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WORLD’S CLINICAL NEWS LEADER Vol.39 No.2 • 5-6/2021

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Radioactive Cement Safer For Spinal Tumor Treatment

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njecting brachytherapy cement into bone is a safer alternative to conventional radiation therapy (RT) for spinal tumors, according to a new study. Developed by researchers at the University of California Irvine (UCI, USA; www.uci.edu) Cont’d on page 19

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Deep Learning X-Ray Algorithm Detects ARDS, Offering COVID-19 Game-Changer

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esearchers have found a solution that could help provide the right care to COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS) which is a life-threatening lung injury that progresses rapidly and can often lead to long-term health problems

or death, but can be difficult for physicians to recognize. A research team at the Michigan Center for Integrative Research in Critical Care (MCIRCC; Ann Arbor, MI, USA) has developed a new artificial intelligence (AI) algorithm that analyzes chest XCont’d on page 13

Pan-Corona Antivirals Can Treat COVID -19 At Earliest Symptoms

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Image Processing Software Detects Ischemic Stroke

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new artificial intelligence (AI) solution assesses cerebrovascular status by quantifying computerized tomography (CT) perfusion scans. The icometrix (Leuven, Belgium; www.icometrix.com) icobrain cva is a cloud-based solution designed to provide fully-automated software reports on lesion core volume and perfusion by quantifying Tmax abnormality and cerebral blood

AI Solution Simplifies Prostate MRI Analysis

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Prof. Imre Berger, Director, Max Planck-Bristol Centre for Minimal Biology at the University of Bristol, UK, and co-head of the international research team that discovered the molecule.

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newly-discovered molecule changes the shape of the SARSCoV-2 spike protein, thus inhibiting the virus’ ability to enter healthy cells. The development is expected to give rise to much needed cost-effective early COVID-19 treatments.

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Spot Check Monitor Improves Patient-Centric Care

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n innovative vital signs monitor delivers precise measurements at rapid speeds, advancing patient comfort, clinical efficiency, and safety. The monitor seamlessly links into a host of different third-party electronic medical

Siemens’ USD 16.4 Billion Acquisition of Varian Forges Cancer Treatment Powerhouse

iemens Healthineers has successfully completed the acquisition of Varian Medical Systems, thus strengthening its position as a holistic partner in healthcare. The combined company is creating a unique,

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INSIDE COVID-19 Update. . . . . 3 News Update. . . . . . . . . . 9 Product News . . . . . . 10-14

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novel artificial intelligence (AI) algorithm processes magnetic resonance imaging (MRI) data in order to increase diagnostic accuracy and detect prostate cancer (PC) earlier. The Quibim (Valencia, Spain; www.quibim.com) qp-Prostate suite is a non-invasive imaging tool that uses MRI data and advanced computer models to investigate prostate anatomy in

highly integrated portfolio of imaging, laboratory diagnostics, artificial intelligence and treatment for the global fight against cancer with significant potential for increased value creation. The acquisition aligns perfectly Cont’d on page 14

News Update. . . . . . . . . 17 Product News . . . . . . 16-18

News Update. . . . . . . . . 21 Product News . . . . . . 20-24

Industry News. . . . . . . . . . 25 International Calendar . . . 26

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COVID-19 Update

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Pan-Corona Antivirals Can Treat COVID-19 at its Earliest Symptoms

linical trials will shortly be launched into pivotal, cost-effective antiviral treatments for COVID-19 following the discovery of a molecule which changes the shape of the SARS-CoV-2 spike protein and in so doing inhibits the virus’ ability to enter cells. A team of top scientists from the University of Bristol (Bristol, UK) who made the recent breakthrough discovery has founded Halo Therapeutics Ltd. (Bristol, UK), a new biotech company for developing ground-breaking and newly patented potential treatments for coronavirus. Studies show the treatments are potentially ‘pan-corona antivirals’ in that they will work against all coronavirus strains - including the highly contagious UK, South African and Brazilian variants. The company is preparing for clinical trials. If approved, the antivirals could be used by patients globally at the first sign of COVID-19 symptoms - stopping the virus in its tracks. The team of scientists had found that exposing the SARS-CoV-2 (coronavirus) virus to a free fatty acid called linoleic acid locks the virus’ spike protein into a closed, non-infective form stopping it in its tracks. The company is now preparing to make an application to start clinical trials with infected patients. If proven to be effective, the antivirals could be used by people of all ages worldwide at the first sign of COVID-19 symptoms, or if they have been in contact with someone with the virus, preventing the virus from taking hold and stopping further transmission. Lab studies indicate the antiviral will work against all pathogenic coronavirus strains including the highly contagious UK, South African and Brazilian variants by preventing the virus from penetrating cells in the nose, throat and lungs. The treatments under development by Halo Therapeutics include a nasal spray and an asthma-type inhaler, and offer the possibility of a game-changing pan-coronavirus antiviral to treat patients at all stages of the disease and to reduce the transmission of the virus. The Halo Therapeutics team is currently engaging investors to help finance multiple parallel clinical trials. If approved, the antiviral treatments could potentially start rolling out to patients globally. “The aim of our treatment is to significantly reduce the amount of virus that enters the body and to stop it from

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multiplying,” explained Professor Imre Berger, Director of the Max Planck-Bristol Centre for Minimal Biology at Bristol and one of the team leading the drug’s development. “Then, even if people are infected with the virus or exposed to it, they will not become ill because the antiviral prevents the virus from spreading to the lungs and beyond. Importantly, because the viral load will be so low it will likely also stop transmission.” “Our vision is that at the first sign of the disease, whether you come into contact with someone who has COVID-19 or you have early symptoms, you would self-medicate at home to stop the virus in its tracks and prevent you from getting ill,” added Professor Christiane Berger-Schaffitzel from Bristol’s School of Biochemistry.

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COVID-19 Update

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s hospitals and healthcare institutions around the world rush to order large volumes of COVID-19 remedies, the hospital/medical devices industry continues its unprecedented expansion to meet exploding global demand. The report that follows provides a survey of news and advances from February 1, till April 30, 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of HospiMedica or visit www.HospiMedica.com. ECMO Life-Support Therapy Can Improve Survival of COVID-19 Patients with Severe Respiratory Failure, Suggests Study A study by physician-researchers at Beth Israel Deaconess Medical Center (BIDMC Boston, MA, USA; www.bidmc.org) and the Brigham and Women’s Hospital (Boston, MA, USA; www.brighamandwomens.org) has provided new evidence that critically ill patients with COVID-19 who were treated with extracorporeal membrane oxygenation (ECMO) - which does the work of the lungs by removing carbon dioxide and adding oxygen to blood outside the body - had better odds of survival than those who were not treated with ECMO. The findings represent the only published study to investigate ECMO’s efficacy for treatment of critically ill patients with COVID-19. COVID-19 Pneumonia Treated With Ultra-Low Doses of Radiotherapy in ULTRA-COVID Study Researchers at La Milagrosa Hospital (Madrid, Spain; www.lamilagrosa.com) designed a prospective study of Ultra-Low Doses of Therapy with Radiation Applied to COVID-19 (ULTRA-COVID) for patients who suffer pneumonia, are not candidates for invasive mechanical ventilation and show no improvement with medical therapy. Based on preliminary results of two patients diagnosed with COVID-19 pneumonia treated with ULTRA-COVID, significant clinical response and a good radiological response was observed in both cases after one radiotherapy session, resulting in both patients being discharged from hospital in less than two weeks after radiation treatment. Breakthrough Coronavirus Treatment Cures Moderate/Serious COVID-19 Patients within Days A new coronavirus treatment developed by scientists at the Ichilov Medical Center (Tel Aviv, Israel; www.tasmc.org. il) has helped several moderate-to-serious COVID-19 patients recover from the disease within days in Phase 1 trials, according to a report by The Times of Israel. In what is being hailed as a “huge breakthrough,” all the 30 COVID-19 patients with moderate or worse symptoms who had been administered the EXO-CD24 substance recovered from the disease.

Experimental Antiviral Drug Proves Dramatically Effective at Preventing and Treating COVID-19 Using a novel in vivo research model containing human lung tissue, scientists at the University of North Carolina School of Medicine (Chapel Hill, NC, USA; www.med. unc.edu) have demonstrated that a broad spectrum, experimental drug EIDD-2801 proved dramatically effective at preventing and treating SARS-CoV-2 infection in human tissue in the lab. Scientists tested how the orally administered experimental drug EIDD-2801 halts SARS-CoV-2 replication and prevents infection of human cells in a new in vivo model containing human lung tissue. They found that the drug was extremely effective at preventing and treating SARSCoV-2 infection. Eli Lilly’s Combination Antibody Drug for COVID-19 Granted FDA Emergency Use Authorization Eli Lilly and Company’s (Indianapolis, Ind, USA; www.lilly.com) neutralizing antibodies bamlanivimab (LY-CoV555) and etesevimab (LY-CoV016) administered together have been authorized for the treatment of recently diagnosed, mild to moderate COVID-19 in patients who are high risk for progression to severe COVID-19. The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for investigational bamlanivimab 700 mg and etesevimab 1400 mg together for the treatment of mild to moderate COVID-19 in patients aged 12 and older who are at high risk for progressing to severe COVID-19 and/or hospitalization. Lung Ultrasound Can Predict Clinical Progression of Severe COVID-19 Patients Lung ultrasound, considered a simple method for diagnosing lung disease, can also help predict the clinical progression of severe COVID-19 patients, according to a new study by researchers at the University of São Paulo’s Medical School (FM-USP; São Paulo City, Brazil; www.fm.usp.br). The study results showed that the higher the lung ultrasound score, the greater the risk of admission to an intensive care unit (ICU), intubation, and death. Roche’s Arthritis Drug Tocilizumab Significantly Reduces Deaths in Patients Hospitalized with Severe COVID-19 Roche’s (Basel, Switzerland; www.roche. com) anti-inflammatory treatment Actemra (tocilizumab) has been found to reduce the risk of death when given to hospitalized patients with severe COVID-19. The Randomized Evaluation of COVID-19 Therapy (RECOVERY) study by researchers at the University of Oxford (Oxford, UK; www.ox.ac. uk) also showed that tocilizumab shortens the  Cont’d on page 4

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ISSN 0898-7270

Vol.39 No.2 • Published, under license, by Globetech Media LLC Copyright © 2020. All rights reserved. Rep­ro­duction in any form is forbidden without express permission. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda dört kere yayınlanır, ücretsiz dağıtılır.

HospiMedica International May-June/2021

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COVID-19 Update Cont’d from page 4

time until patients are successfully discharged from hospital and reduces the need for a mechanical ventilator. Hospital System Remotely Monitors Fetal Health of Pregnant COVID-19 Patients Sheba Medical Center’s (Tel Aviv, Israel; www.shebaonline.org) hospital system will enable real-time fetal and maternal heart rate monitoring and analysis of pregnant COVID-19 patients by midwives and obstetricians, limiting the amount of physical interaction to potentially reduce the risk of coronavirus exposure and spread. Sheba has initiated a pilot to test both the HeraBEAT fetal heart rate monitor and the HeraCARE digital pregnancy monitoring platform from HeraMED Ltd. (Netanya, Israel; www.hera-med.com). Additionally, Sheba will also test the PulseNmore ES ultrasound system from PulseNmore Ltd. (Omer, Israel; www.pulsenmore.com) that docks with the patient’s mobile phone to deliver high quality images which can be viewed live by the hospital physicians via a secure telemedicine platform. Breakthrough Respiration Treatment to Be Used On Critically Ill COVID-19 Patients

www.ridgebackbio.com) study which found that individuals with early COVID-19 who were treated with its investigational oral antiviral agent saw a quick reduction in the infectious SARS-CoV-2 virus. The findings on one secondary objective from the Phase 2a randomized, double-blind, placebo-controlled trial to evaluate the safety, tolerability, and efficacy to eliminate SARS-CoV-2 viral RNA of molnupiravir (EIDD-2801/MK-4482), showed a reduction in time (days) to negativity of infectious virus isolation in nasopharyngeal swabs from participants with symptomatic SARS-CoV-2 infection, as determined by isolation in Vero cell line culture. Endotracheal UVA Light Treatment Significantly Reduces SARS-CoV-2 Viral Load in Critically Ill COVID-19 Patients Data from a new study by Aytu BioScience, Inc. (Englewood, CO, USA; www.aytubio.com) indicate that endotracheal UVA light catheter therapy reduces SARS-CoV-2 viral load and improves clinical outcomes in mechanically ventilated SARS-CoV-2 patients. The first in-human, open label, clinical trial in SARS-CoV-2 patients found that endotracheal  Cont’d on page 5

The intensive care unit (ICU) of the Department of Cardiac Surgery at Sheba Medical Center (Tel Aviv, Israel; www.shebaonline.org) will test the innovative Augmented Respiration Technology (ART) from Inspira Technologies (Ra’anana, Israel; www.inspira-technologies.com) on severely ill COVID-19 patients. ART is the world’s first technology to oxygenate blood directly as a first line support. The ART system is an alternative to highly invasive mechanical ventilation systems, preventing the need for medically induced comas and intubation. The technology solution lowers the risks and costs of existing ventilation systems by allowing patients to remain awake and mobile during treatment, and the simple system design allows for broader medical use. Use of Statins to Lower Cholesterol Increases Survival By 50% in Severe COVID-19 Patients, Finds New Study People who took statins to lower cholesterol were approximately 50% less likely to die if hospitalized for COVID-19, according to a new study by physicians at Columbia University Irving Medical Center (New York, NY, USA; www.cuimc.columbia.edu). Other studies and meta-analyses from China have also suggested a survival benefit from statins among COVID-19 patients. However, these results may not apply to patients in Western countries who generally have more cardiovascular disease. The current study is one of the larger studies confirming the association. Administering Zinc Aids Recovery and Reduces Mortality in COVID-19 Patients, Finds New Study Administering zinc supplements to COVID-19 patients with low levels of this element may be a strategy to reduce mortality and recovery time, according to a new study by physicians and researchers from the Hospital del Mar (Barcelona, Spain; www.parcdesalutmar.cat) and Pompeu Fabra University (Barcelona, Spain; www.upf.edu). The study found that administering zinc to COVID-19 patients not only helped towards their recovery but also helped to prevent risk groups, like the elderly, from suffering the worst effects of the disease. Unique Low-Cost, Non-Electric Ventilator Could Help Hospitals Treat COVID-19 Patients A new low-cost ventilator designed by a team of engineers from Loughborough University (Loughborough, UK; www.lboro.ac.uk) that not require electricity could help hospitals treat COVID patients. The ShiVent system, a unique low-cost, non-electric ventilator developed in response to the COVID-19 pandemic, was created to allow non-specialized workers to treat patients with coronavirus. Merck’s Oral COVID-19 Antiviral Treatment Causes Quick Reduction in SARS-CoV-2 Merck (Kenilworth, NJ, USA; www.merck.com) has announced preliminary results from Ridgeback Biotherapeutics’ (Miami, FL, USA;

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GLUCOSE METERS

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The Philips IntelliVue MX850 bedside patient monitor offers advanced functionality, flexible configuration options and extensive range of measurements, making it well-suited to the demands of high-acuity care environments.

The Rad-G with Temperature is a handheld device providing clinically proven SET pulse oximetry, respiration rate from the pleth (RRp), and other important parameters alongside clinical-grade, noncontact infrared thermometry.

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COVID-19 Update Cont’d from page 5

UVA light treatment was associated with a significant reduction of SARSCoV-2 viral load and improvement in WHO clinical severity scores. Advanced Machine Learning Algorithm Accurately Predicts Risk of COVID-19 Progressing to Severe Disease or Death An advanced machine learning algorithm developed by researchers at Johns Hopkins Medicine (JHM; Baltimore, MD, USA; www.hopkins medicine.org) uses easily obtained “bedside” clinical data to accurately predict a patient’s risk of developing severe COVID-19 or dying from the disease. The advanced machine-learning system can accurately predict how a patient’s bout with COVID-19 will go, and relay its findings back to the clinician in an easily understandable form. The new prognostic tool, known as the Severe COVID-19 Adaptive Risk Predictor (SCARP), can help define the one-day and seven-day risk of a patient hospitalized with COVID-19 developing a more severe form of the disease or dying from it. Aspirin’s Lung-Protective Effects Could Decrease Ventilation, ICU Admission and Death in COVID-19 Patients Researchers from the George Washington University (Washington, D.C., USA; www.gwu.edu) have found that aspirin may have lung-protective effects and reduce the need for mechanical ventilation, ICU admission and in-hospital mortality in hospitalized COVID-19 patients. According to the final results of the study indicating the lung protective effects of aspirin, low dose of the medicine used to prevent stroke and heart attack may reduce the need for mechanical ventilation, ICU admission and in-hospital mortality in hospitalized COVID-19 patients. Ultrasound Waves at Medical Imaging Frequencies Can Damage SARS-CoV-2 and Could Treat COVID-19 Simulations conducted by researchers in MIT’s Department of Mechanical Engineering (Cambridge, MA, USA; www.web.mit.edu) have shown that ultrasound waves at medical imaging frequencies can cause the shell and spikes of the SARS-CoV-2 virus to collapse and rupture, suggesting the possibility of ultrasound-based treatment for COVID-19. The new study suggests that coronaviruses may be vulnerable to ultrasound vibrations, within the frequencies used in medical diagnostic imaging. Small Device Has Big Implications for COVID-19 Monoclonal Antibody Treatments A small, simple device from Hometa (Albany, NY, USA; www.hometa.

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com) has given new viability to the modality of gravity infusion for administering monoclonal antibody therapies to COVID-19 patients. Hometa’s DripAssist Supplemental Infusion Rate Monitor offers a new middle ground between the simplicity of gravity infusion and the assuredness of a pump to ensure monitoring and control while delivering monoclonal COVID-19 antibody therapies. GE Healthcare’s New Wireless Pocket-Sized Ultrasound Enables Quick Lung Scans of COVID-19 Patients at POC GE Healthcare (Chicago, IL, USA; www.gehealthcare.com) has launched a pocket-sized ultrasound even as the COVID-19 pressure on health systems has made handheld ultrasound an essential tool to quickly image the heart and lungs both in and outside the hospital. GE Healthcare has unveiled Vscan Air, a cutting-edge, wireless pocket-sized ultrasound that provides crystal clear image quality, whole-body scanning capabilities, and intuitive software - all in the palm of clinicians’ hands. Novel Oral COVID-19 Vaccine Has Implications for Ease of Administration Anytime and Anywhere Oramed Pharmaceuticals Inc. (Jerusalem, Israel; www.oramed.com), a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, has entered into definitive agreements to form a joint venture focused on the development of novel oral COVID-19 vaccines. The new company, Oravax Medical Inc., is based on Oramed’s proprietary POD oral delivery technology and Premas Biotech’s (Haryana, India; www.premasbiotech.com) novel vaccine technology. The oral COVID-19 vaccine successfully produced antibodies in a pre-clinical study after a single dose and could also be a good candidate for protection against SARS-CoV-2 variants due to triple antigen targeting. Regeneron’s Antibody Cocktail Reduces Hospitalization or Death by 70% in COVID-19 Patients Regeneron Pharmaceuticals, Inc.’s (Tarrytown, NY, USA; www. regeneron.com) investigational antibody cocktail REGEN-COV (casirivimab with imdevimab) reduced hospitalization or death by 70% in non-hospitalized patients with COVID-19 in Phase 3 trial. Regeneron’s antibody cocktail REGEN-COV also significantly shortened the duration of symptoms by four days in the largest trial to date assessing a COVID-19 treatment in infected non-hospitalized patients. Regeneron also announced positive data from two Phase 3 trials of recently infected asymptomatic COVID-19 patients, evaluating REGEN-COV 1,200 mg administered via subcutaneous (SC) administration. The first Phase 3 trial (2069A) assessed the ability of REGEN-COV to reduce the risk and burden of COVID-19 infection among household contacts of SARS-CoV-2 infected individuals. The second Phase 3 trial  Cont’d on page 6 HospiMedica International May-June/2021

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COVID-19 Update Cont’d from page 6

(2069B) of recently infected asymptomatic COVID-19 patients, for evaluating REGEN-COV 1,200 mg administered via SC administration found that REGEN-COV reduced the overall risk of progressing to symptomatic COVID-19 by 31% (primary endpoint), and by 76% after the third day.

Pfizer Evaluates Oral COVID-19 Antiviral Therapy for Prescribing At First Sign of Infection without Requiring Hospitalization Pfizer Inc. (New York, NY, USA; www.pfizer.com) is progressing to multiple ascending doses after completing the dosing of single ascending doses in a Phase 1 study in healthy adults to evaluate the safety and tolerability of an investigational, novel oral antiviral therapeutic for SARS-CoV-2, the virus that causes COVID-19. The oral antiviral clinical candidate PF-07321332, a SARS-CoV2-3CL protease inhibitor, has demonstrated potent in vitro anti-viral activity against SARS-CoV-2, as well as activity against other coronaviruses, suggesting potential for use in the treatment of COVID-19 as well as potential use to address future coronavirus threats. Pfizer CEO Albert Bourla told CNBC that if the clinical trial currently underway for testing the company’s new COVID-19 antiviral therapy goes well and it receives approval from the US Food and Drug Administration, then the drug could be distributed across the US by the end of the year. Thermo Fisher Launches In-Air SARS-CoV-2 Surveillance Solution Thermo Fisher Scientific Inc. (Waltham, MA, USA; www.thermofish er.com) has launched the Thermo Scientific AerosolSense Sampler, a new surveillance solution designed to deliver fast and highly reliable insight into the presence of in-air pathogens, including SARS-CoV-2. Confirming the presence of pathogens like SARS-CoV-2 in a space during a known time interval enables decision makers in hospitals and other indoor facilities to take actions to protect their employees and provide the public with confidence. Thermo Fisher has designed the AerosolSense Sampler to capture a wide variety of in-air pathogens and has specifically validated it for the SARS-CoV-2 pathogen.

its course, and reduce the severity of symptoms and damage in those already infected. COVID-19 Sweat Sensor Alerts Doctors and Patients to Impending Cytokine Storm in Real Time A wristwatch-like device called the SWEATSENSER Dx that is being commercialized by EnLiSense LLC (Allen, TX, USA; www.enlisense. com) measures cytokine levels in passive sweat to alert doctors and patients to a looming COVID cytokine storm. Early detection is important because once a cytokine storm has been unleashed, the excessive inflammation can damage organs, causing severe illness and death. The sweat sensor acts as an early warning system for an impending cytokine storm, which could help doctors more effectively treat COVID-19 patients. Delivering Portable Chest Radiography through Glass (TG-CXR) Reduces COVID-19 Infection Risk in Hospitals A study by technologists at the Department of Radiology, St. Michael’s Hospital, University of Toronto (Toronto, ON, Canada; www.utoronto. ca) to understand the cost and benefit of adopting portable chest radiography through glass (TG-CXR) at a tertiary care centre during the COVID-19 pandemic has found the novel technique to be particularly beneficial. The technique has the benefit of allowing one technologist to stay outside of the patient room while operating the portable radiography machine, thus reducing PPE use, decreasing the frequency of radiography machine sanitization and reducing their exposure to potentially infectious patients. The study also found that adoption of the TG-CXR technique during the COVID-19 pandemic involves a minimal one-time cost, but can result in a significant benefit over the year.  Cont’d on page 7

Widely Used Transplant-Rejection Drug Cyclosporine Identified as Potential New COVID-19 Treatment A team led by scientists in the University of Pennsylvania’s Perelman School of Medicine (Philadelphia, PA, USA; www.pennmedicine.org) has identified nine potential new COVID-19 treatments, out of which three are already approved by the US FDA for treating other diseases and also include the widely used transplant-rejection drug cyclosporine. The study highlights cyclosporine as particularly promising, as it appears to works against SARS-CoV-2 in respiratory and non-respiratory cells, and via two distinct mechanisms: inhibiting cell enzymes called cyclophilins, which the coronavirus hijacks to support itself, and suppressing the potentially lethal inflammation of severe COVID-19. Advantech Launches One-to-One Thermal Screening Kiosk with Video AI-Integrated System to Reduce Spread of COVID-19 Advantech (Irvine, CA, USA; www.advantech.com) has launched its One-to-One Visitor Thermal Screening Kiosk, the cost effective version of its Visitor Thermal Screening System that was released in 2020. This new solution has the original solution’s abilities to monitor and record events for abnormal body temperature with a real-time alarm, but at a budget-friendly price for smaller businesses. Portable Nasal Spray That Destroys SARS-CoV-2 Could Prove to Be Breakthrough COVID-19 Treatment A self-administered nasal spray application from SaNOtize Research & Development Corp. (Vancouver, BC, Canada; www.sanotize.com) that was found to have reduced SARS-CoV-2 log viral load by more than 95% in infected participants within 24 hours of treatment, and by more than 99% in 72 hours could prove to be a breakthrough treatment for COVID-19. Results of clinical trials from SaNOtize Nitric Oxide Nasal Spray (NONS) indicate that it could be a safe and effective antiviral treatment that could prevent the transmission of COVID-19, shorten

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The BeneFusion e Series streamlines workflow via a 3.5” colored capacitive touchscreen, which features an intuitive UI for smooth touch operation, supporting stable and seamless infusions with an automatic multi-channel relay.

The Breas Vivo 65 is an advanced homecare ventilator designed to deliver secure and comfortable (life-support) treatment to adult and pediatric patients, featuring a comprehensive set of modes, circuits and accessories.

The BlueDop Vascular Expert kit accurately detects lower limb arterial disease by using a patented process to determine ABPI in less than a minute. The kit includes BlueDop Egg with BlueDop Vascular Expert software.

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COVID-19 Update Cont’d from page 7

Deep Learning Algorithm That Detects ARDS with Expert-Level Accuracy Could Be Game-Changer in COVID-19 Treatment Researchers at the Michigan Center for Integrative Research in Critical Care (MCIRCC; Ann Arbor, MI, USA; www.mcircc.umich. edu) have found a solution that could help provide the right care to COVID-19 patients with Acute Respiratory Distress Syndrome (ARDS) which is a life-threatening lung injury that progresses rapidly and can often lead to long-term health problems or death, but can be difficult for physicians to recognize. The research team has developed

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a new artificial intelligence (AI) algorithm that analyzes chest X-rays for ARDS and have shown that it can identify ARDS findings with higher accuracy than many physicians. New Treatment Based on Natural Molecules Improves Lung Function, Could Keep COVID-19 Patients off Ventilator A new treatment developed by researchers at The Ohio State University (Columbus, OH, USA; www.osu.edu) is among the first known to reduce the severity of acute respiratory distress syndrome (ARDS) caused by the flu in animals and could also keep COVID-19 patients off the ventilator. Tests done in mice infected with high doses of influenza showed that the treatment could improve lung function in very sick mice and prevent progression of disease in mice that were pre-emptively treated after being exposed to the flu. The hope is that it may also help humans infected with the flu, and potentially other causes of ARDS) such as SARS-CoV-2 infection.

Adaptable Ultrasound System Facilitates Bedside Exams

new point-of-care ultrasound system (POCUS) offers advanced image clarity, a suite of workflow efficiency features, and an adaptable form factor. The Fujifilm SonoSite (Bothell, WA, USA; www.sonosite. com) Sonosite PX boasts adaptable work surface positioning for optimal ergonomics, which together with the small footprint and adjustable height allow closer bedside access for the clinician. A simplified, intuitive user interface displays most-used controls, calculations, and annotations. A library of over 140 onboard scanalong three dimensional animation educational videos aid new users to execute a quality POCUS exam, supported by a new range of linear, curved, and phased array transducers. Information essential to completing an exam and storing it in the electronic health record (EHR), such as patient information, reports, worksheets, and other documentation are all placed in one location, saving time and effort and allowing intuitive navigation of the Sonosite PX user interface. Ultrasound findings annotated at the point-of-care are also integrating seamlessly by the Sonosite Synchronicity solution, a POCUS workflow manager that supports unbroken credentialing, quality assurance, and billing across departments and institutions. “Every aspect of Sonosite PX was designed specifically for the clinicians on the front lines of medicine. To optimize clinician ergonomics and improve efficiency, the system has an innovative

and adaptable work surface that can be used in a horizontal or vertical position based on the situational needs of the exam,” said Rich Fabian, President and COO of FujiFilm Sonosite. “The exceptional image clarity is the result of a new proprietary imaging technology; seeing anatomy more clearly with Sonosite PX provides an unparalleled level of confidence for diagnostic and procedural applications.” The exponential growth of POCUS in the intensive care unit (ICU) and hospital clinical wards has been driven by mounting clinical evidence showing heightened patient safety and less risk of complication when key interventions are performed with ultrasound guidance at the point of care, such as imaging the abdomen, heart, and lungs, and when guiding interventional procedures, such as nerve blocks and targeted injections. Image: The Sonosite PX POCUS system (Photo courtesy of FujiFilm) HospiMedica International May-June/2021

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Filtration System Optimizes Fluoroscopy X-Ray Beam

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novel system reduces unnecessary radiation exposure during fluoroscopically guided procedures by containing the X-ray beam in the relevant region of interest (ROI). The ControlRad (Atlanta, GA, USA; www.controlrad.com) ControlRad Select is intended for use with the Siemens Healthcare (Erlangen, Germany; www.healthcare.siemens.com) Artis zee C-arm fluoroscopic system during diagnostic, surgical, and interventional procedures; it cannot be used independent of the Artis zee system. The ControlRad Select consists of a radiation filtering system semi-permanently fixed to the Siemens Medical Artis zee C-arm, in order to aid in reducing both patient and clinicians’ radiation exposure. The system claims to reduce radiation dose by 85% outside the clinician-selected ROI, and within the un-collimated field of view (FOV). Components include a touch tablet that provides operational control via a graphical user interface (GUI) that enables the clinician to select the ROI; a titanium filter that is partially transparent to X-ray radiation; ControlRad proprietary hardware, software and firmware modules; and a communication interface. The filter is installed on top of the C-arm’s collimator, and does not affect or modify functionality. “Radiation from C-arm procedures may increase the risk of brain cancer, cataracts, strokes, and atherosclerosis in over 17 million fluoroscopic procedures in the United States very year,” said Chris Fair, president of the Mobile C-arm division at ControlRad. “Regardless of whether it is a spine or orthopedic procedure, pain management or urology case, our technology reduces radiation exposure and protects those who are saving the lives of others.”

Portable Gamma Ray Camera Speeds Up Cancer Location

“The health risks to the medical staff due to lifetime radiation exposure in cath labs have been well documented, including increased incidence of cataracts, atherosclerosis and even left-brain tumors,” said Simon Dixon, MD, chief of cardiology at Beaumont Hospital (Royal Oak, MI, USA). “We recently completed a clinical trial designed to evaluate how this novel technology might reduce radiation exposure. I have long been passionate about finding innovative ways to improve safety for my colleagues in the lab while they are performing lifesaving procedures for our patients.” Image: The ControlRad Select optimizes the X-ray beam to reduce radiation by 85% (Photo courtesy of ControlRad)

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hybrid gamma camera (HGC) could improve tumor localization in procedures such as sentinel lymph node biopsy, according to a new study. Developed at Loughborough University (LBORO; United Kingdom; www.lboro.ac.uk) and the University of Leicester (United Kingdom; www.le.ac.uk), the HGC combines a stereoscopic gamma-ray pinhole camera and stereoscopic optical imaging, taking two different images from different angles and then calculating the exact position of whatever is being observed. The device, which is about the size of a hairdryer, can be used to calculate the depth of a radioisotopic source beneath the skin surface, without any external positional tracking, with a mean deviation of less than five mm for imaging distances of 50–250 mm. The researchers are planning to work with medical professionals in Uruguay to test the HGC, as currently there are only three 3D nuclear imaging centers--in Montevideo, Durazno, and Salto--that are capable of gamma ray imaging, and patients must travel hundreds of kilometers for initial imaging, and then return to their city of origin for surgery. If patients cannot attend one of these nuclear medicine centers, they risk having all their axillary nodes removed for sentinel lymph node (SLN) biopsy, instead of less invasive surgery. The study was published on February 11, 2021, in Physics in Medicine & Biology. “The camera works by using a pinhole which allows an image of the source of gamma radiation to be taken. Doing this twice from two slightly different positions allows the camera to triangulate the exact distance from the source giving an accurate 3D reading,” said lead author Sarah Bugby, PhD, of the LBORO School of Science. “By combining gamma and optical imaging, this 3D information will tell the user where and how deep a source of radioactivity is. This has applications in radioguided surgery, and may also find use in other areas in the nuclear industry.” Stereoscopic imaging triangulation is a well-established technique for distance estimation, such as in astronomy to measure the vast distances to stars. As the HGC acquires both gamma and optical images, with a known relationship between the magnification factor of each, source distance can be calculated to the imaging surface. Combining the two measurements therefore allows the calculation of source depth beneath the surface.

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C-ARM

FLAT PANEL DETECTOR

CT SYSTEM

The OSCAR Classic image intensifier C-Arm offers 800mm free space and 180º orbital rotation, providing a convenient operation environment for the operator. Its low dose mode sets and manages the radiation dose automatically.

The Aquarius 8600 flat panel detectors are offered in both Cesium Iodide (CsI) and Gadolinium Oxysulfide (GdOS), in addition to IDC’s XSeries CCD-based DR technology platform.

The Persona CT 85cm CT System is equipped with best-in-class detector and system design, advanced image-processing technologies, higher rotational speed, and greater noise reduction to provide precision and accuracy.

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Minimal-Footprint MRI Scanner Helps Address Overloads and Backlogs

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he Esaote (Genova, Italy; www.esaote.com) O-scan Elite MRI facilitates transversal, sagittal, coronal and oblique section imaging of the arm, including hand, wrist, forearm, and elbow, but excluding the upper part of the arm; and portions of the leg, including foot, ankle, calf, and knee, but excluding the thigh. As the O-scan MRI runs on a standard power outlet, and does not require helium cooling, it is a viable, cost effective solution that also impacts patient comfort. For pathologies in which it can be beneficial to image the joint in real-time movement, the Esaote True Motion can perform a regular MRI sequence. The Elite configuration comes with the Esaote AgilExam AI software, which recognizes the anatomy and automatically suggests the setup of the MRI scan according to the chosen protocol, improving image consistency and reducing exam times. Once the scout scan has been acquired, setup time for a complete exam is a matter of seconds, during which AgilExam adjusts the slice orientation and number of slices of all the scans, as per the chosen protocol. AgilExam is available for the knee, ankle, and wrist, but is not compatible with MRI conditional implants. “The Esaote Extremity MRI creates excellent diagnostic images of the elbow, wrist, hand, and fingers from the upper extremity and the knee, ankle, foot and toes from the lower extremity,” said Eric Lazar, MD, of University Radiology (East Brunswick, NJ, USA). “The patient reclines comfortably in an open-air environment while only the imaged body part lies within the machine. This is the first of its kind through our suite of 23 offices, and we are happy to welcome patients to our East Brunswick flagship office for this new service.”

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MRI scanners can have ultraweak, weak, medium, strong, and superstrong magnetic fields, as measured in Tesla units. Highest-quality scans are usually taken with the aid of superconducting magnetic systems that generate very strong magnetic fields, providing the highest image resolution. But such high-field systems require liquid helium to keep the superconducting magnets cool, which demands high-power consumption, large separate facilities, and improved shielding. Image: The O-scan Elite dedicated MRI for extremities (Photo courtesy of Esaote)

Glass-Free Cesium Detector Benefits Medical Imaging

new cesium flat panel detector (FPD) offers superb resolution, better detail, and a reduced exposure dose as compared to gadolinium detectors. The Carestream (Rochester, NY, USA; www.carestream.com) Lux 35 Detector is a lightweight, glass-free ergonomically designed FPD that enables easier handling and minimizes accidental drops and slips, allowing for easier positioning. Its light weight (just 2.3 kg), small size (only 35 cm x 43 cm), and beveled edges provide more patient comfort, especially with bedridden patients. Specially designed strategically placed finger grips help position the detector effortlessly, and a graphical user interface (GUI) on the back displays status and error

information notifications. The Lux 35 uses Carestream’s ImageView Software – powered by Eclipse – for high image quality and consistent presentation. The wireless detector also features proprietary X-Factor for sharing with other compatible Carestream DRX equipment. LED lights on the detector provide immediate information on its status, informing the radiographer that the detector is connected and in ready status, and alerting them when the battery is low and needs to be swapped out. The Lux 35 supports a variety of image-processing options, including Tube and Line Visualization, Pneumothorax Visualization, EVP Plus,  Cont’d on page 12 HospiMedica International May-June/2021

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Medical Imaging

3D Imaging System Improves Surgical Suite Efficiency

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new radiographic system provides precise standard and volumetric interoperative imaging for spinal and orthopedic procedures. The GE Healthcare (GE; Chicago, IL, USA; www.gehealthcare.com) OEC 3D is built on GE’s OEC Elite C-arm platform, and includes a 31x31 cm CMOS detector designed to provide high resolution images with a field of view large enough to capture L2 to S1 in a single shot. The 200° isocentric sweep creates 3D images with 19x19x19 cm volume and 512³ voxel resolution. In addition to 3D imaging, the system also provides a comprehensive 2D imaging chain, which allows surgical units to store multiple image types within the same patient case for easy reference. The OEC 3D detailed, fully reconstructed multi-planar 3D images displayed on a 4K ultra high definition (UHD) monitor, all delivered less than 30 seconds after a scan is completed. The GE 3DXR reconstruction engine allows surgeons to analyze the volume reconstructed images quickly and easily with the aid of an advanced visualization package with preferred layouts and views, such as drag and drop, paging, and zoom. Advanced visualization also enables change of perspective views, panning through slices, and adjusting planes in coronal, sagittal, and axial views. A step-by-step guide is designed to make scanning easy and intuitive by taking users through each stage of 3D scanning, from pre-scan to completion, allowing those with minimal training to complete a scan. For user convenience, familiar OEC icons and interfaces enable control from the C-arm’s OEC Touch, OEC Touch Tableside, remote user interface (RUI), or workstation. The OEC 3D has also been designed to integrate seamlessly with navigation systems, and the open interface architecture is

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AI Algorithm Automates Cystic Fibrosis CT Scan Analysis

new artificial intelligence (AI) algorithm can analyze CT scans of cystic fibrosis (CF) patients in several seconds, without human interference. The Thirona (Nijmegen, The Netherlands; www.thirona.eu) Pragma-AI is designed to automatically identify lung abnormalities related to CF, such as collapsed lung tissue and abnormal airways. Sensitive, objective information on the pattern and extent of CF lung disease is immediately available, helping clinicians monitor disease progression and supporting clinical treatment planning. Pragma-AI is part of the company’s LungQ quantification software package, which precisely detects emphysematous regions in the lungs, air-trapping, airway morphology, and fissure completeness. “Artificial intelligence algorithms make medical image analysis easier, more accurate and more effective; but it is hard work. Developing an algorithm that works as well as, and sometimes even better than a clinician, takes time,” said Eva van Rikxoort, Managing Director of Thirona. “The algorithm will be able to quickly and accurately detect bronchiectasis and mucous quantifications in very young patients with CF, making personalized treatment easier.” “These developments pave the way for using the PRAGMA method in both clinical trials and clinical care. It allows for large scale investigation of CF lung disease in both research studies and clinical trials. This is a crucial component in the evaluation of new expensive treatment options for patients suffering from CF,” said Professor Harm Tiddens, MD, of Erasmus Medical Center (Rotterdam, The Netherlands). “CF patient registries, collecting information on the health status of CF patients, have already shown interest in the PRAGMA-AI method.” CF is an autosomal recessive genetic disorder that affects mainly the lungs, but also the pancreas, liver, and intestine. It is characterized by abnormal transport of chloride and sodium across an epithelium, leading to thick, viscous secretions. The name refers to the characteristic scarring (fibrosis) and cyst formation within the pancreas, first recognized in the 1930’s. Difficulty breathing is the most serious symptom, resulting from frequent lung infections that are usually treated with antibiotics and other medications.

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built for future integrations with robotics or AI applications. “We’re thrilled to introduce OEC 3D to clinicians who want amazing 3D volumetric images quickly during intraoperative procedures,” said Gustavo Perez Fernandez, president and CEO of GE Healthcare Image Guided Therapies. “Built on the successful OEC Elite C-arm platform, the familiar performance and functionality of the OEC 3D C-arm will make 3D imaging routine for complex spine and joint replacement procedures.” With the rise of minimally invasive procedures such as spinal fusion or lumbar spine scoliosis, seeing all the anatomy of interest, such as cortical rims, pedicle diameters, or orbital floors in fine detail is critical. And omplex spine procedures, which include insertion and placement of pedicle screws and prevention or correction of deformities, also require precise views of spinal structures. Image: The OEC 3D system with C-arm (Photo courtesy of GE Healthcare)

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PHANTOM PATIENT FOR VMAT & IMRT CIRS

ULTRASOUND SYSTEM

X-RAY SYSTEM

The CIRS Shoulder, Head and Neck End-to-End Verification Phantom (SHANE) is designed for endto-end testing of treatment planning systems and can be used for every step in this process.

The X-CUBE 90 diagnostic ultrasound system provides high-resolution images based on X+ Architecture and X+ FIT technology, featuring increased data transmission capacity and speed.

The DRX-Compass X-ray system has just the right selection of advanced features and options to take your workflow to a new level of efficiency. It delivers exceptional image quality that supports accurate diagnosis.

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AI Suite Detects Most Common Chest X-Ray Findings

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new collaboration between Royal Philips (Amsterdam, The Netherlands; www.philips.com) and Lunit (Seoul, South Korea; www.lunit.io) will make Lunit’s AI software, the Insight CXR chest detection suite accessible to users of Philips’ diagnostic X-ray solutions. CXR detects ten of the most common findings in a chest X-ray, incluindg small and subtle pulmonary nodules overlapped in the hilar shadow, ribs, heart, and diaphragm, enabling radiologists to reduce overlooked lung cancer cases, especially during regular check-ups. Lunit Insight CXR is designed to instantly analyze of chest X-ray images by mapping radiological findings and displaying a scored calculation of actual existence. The algorithm shows a 9799% accuracy rate in the detection of lung nodules, calcifications, consolidation, fibrosis, pneumothorax, pneumoperitoneum, cardiomegaly, pleural effusion, mediastinal widening, atelectasis, and tuberculosis. Data on the detected lesions is presented in the form of heatmaps and/or contour maps, with an abnormality score reflecting the AI’s calculation of the actual presence of the detected lesion. “Radiology departments and their technologists are continually under pressure. They face high patient volumes, and every improvement in workflow can make a big impact,” said Daan van Manen, general manager for diagnostic X-ray at Philips. “Our partnership with Lunit to incorporate their diagnostic AI into our X-ray suite combines with a host of smart workflow features in the Philips radiography unified user interface (Eleva), across our digital radiography systems that enables a smooth and efficient, patientfocused workflow.” “By partnering with Philips, one of the biggest medical device companies globally, our AI will be available to its significant global installed base. With the start of this partnership, we look forward to

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further expanding our collaboration to make data-driven medicine the new standard of care,” said Brandon Suh, CEO of Lunit. “Lunit will continue to build upon its current AI offering, making it better and better with time, and will continue to deliver best-in-class AI.” Image: Insight CXR detects abnormalities on a chest X-ray image (Photo courtesy of Lunit)

Glass-Free Cesium Detector Benefits Medical Imaging

Bone Suppression, and many more. “The lightweight Lux 35 Detector helps ease stress on radiographers, especially when doing mobile imaging, as they are constantly moving the detector from machine to patient,” said Jill Hamman, worldwide marketing manager of Global X-ray Solutions at Carestream. “The lighter weight and ergonomic finger grips result in less stress and fatigue on radiographers. Easier positioning of the detector can help

speed up the time it takes to conduct mobile imaging rounds as well.” FPDs in various cassette formats for general radiographic examinations are equipped either with a Cesium Iodide (CsI) or GOS (Gadolinium oxysulfide) scintillator. CsI typically yield more detailed, higher resolution images, with a better light output. And since CsI panels are more sensitive to dose levels, the radiation dose is about 10% lower than on in a GOS FPD. GOS FPDs, however, usually come with a lower price tag. HospiMedica International May-June/2021

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Medical Imaging

Deep Learning X-Ray Algorithm Detects ARDS, Offering COVID-19 Game-Changer

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rays for ARDS. Many patients who die from COVID-19 die from complications associated with the ARDS which occurs when fluid builds up in the lungs’ air sacs and deprives the organs of the oxygen they need to function. Accurately interpreting a patient’s chest X-ray is a critical component of diagnosing ARDS. However, studies demonstrate that up to 65% of patients with ARDS are diagnosed late or missed and do not receive evidence-based therapies that improve outcomes. Every day of delay in evidence-based treatment is associated with increased mortality. Thus, there is an urgent need for computational tools that can analyze chest radiology studies to support clinicians with real-time ARDS surveillance and ensure fidelity with evidence-based treatments. The MCIRCC research team showed that their AI algorithm that analyzes chest X-rays for ARDS could, in fact, identify ARDS findings with higher accuracy than many physicians. It also performed well when it was externally validated in patients from another hospital system. The algorithm they used, a type of machine-learning model called deep convolutional neural networks (CNNs), had 121 layers and seven million parameters. Using an innovative approach, the team then trained the algorithm to identify common radiologic findings, but not ARDS, on 450,000 chest x-rays from publicly available sources. Then they trained the algorithm to detect ARDS using a unique dataset of 8,000 chest x-ray studies carefully reviewed and annotated for ARDS by Michigan Medicine physicians. This approach is called transfer learning, which has many parallels to

how humans learn. Further research is needed to evaluate the impact of the algorithm in a clinical setting, but the team at MCIRCC is confident that it will be game-changer. They envision it will help physicians identify ARDS patients more quickly and accurately, and ensure patients receive evidence-based care. “In our previous work, we found that physicians have difficulty identifying findings of ARDS on chest X-rays,” said Dr. Michael Sjoding, a pulmonary critical physician at Michigan Medicine and lead author of the study. “Early recognition and treatment are key factors in treating ARDS. Delays can be catastrophic. We now have a highly reliable way to identify ARDS patients, which will also allow us to study them more effectively.”

AI Solution Simplifies Prostate MRI Analysis

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extreme detail. The suite automatically detects, identifies, and segments each prostate region, including the transitional zone, peripheral zone, and the seminal vesicles, as well as other areas defined in the PI-RADS v2.1 guidelines. It also automatically runs processing steps, such as arterial input function (AIF) selection, motion correction, and spatial smoothing algorithms in order to improve image quality and minimize heterogeneity across vendors. The web-based DICOM viewer enables users to configure and modify the processing steps. Reporting is also accelerated with qp-Prostate’s automated rules engine, allowing an end-to-end workflow. Reports can be sent to the picture archive and communication system (PACS) instantaneously and synced with a patient’s folder, so that complete medical information is available to radiologists at any time. Users can edit the standard PI-RADS v2.1 templates and re-launch any analysis if deemed necessary. The tool works with both biparametric (T2+DWI and T2+DCE) or multiparametric (T2+DWI+DCE) MRI exams. “We challenged ourselves to build the world’s finest AI platform for prostate imaging, to help increase diagnostic precision as a tireless companion to the clinician, helping transform the men’s care journey,” said Angel Alberich Bayarri, MD, CEO of Quibim. “Instead of analyzing the prostate as a whole, the solution can segment the prostate’s transitional zone, peripheral zone and seminal vesicles, as well as other regions to extract clinically meaningful quantitative information from the MRI examination as a potential aid for early and accurate clinicians’ diagnosis.” “MRI is the perfect modality for prostate evaluation, however only 5% of radiologists are trained to interpret prostate MRI data,” said Professor Luis Martí-Bonmatí, MD, co-founder of Quibim. “qp-Prostate shortens the learning curve and reduces the workload for radiologists, potentially increasing productivity by reducing image reading time, and generates more meaningful insights for patient diagnosis and monitoring.” Early detection of PC is an important, but challenging task for oncologists, as early-stage disease is asymptomatic. Current diagnostic tools, such as prostate-specific antigen (PSA) markers in blood have limitations, and may result in patients undergoing invasive biopsies or even unnecessary surgeries.

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PET/CT SCANNER

DIAGNOSTIC MONITOR

MRI ENTRYWAY SYSTEM

The Biograph Vision Quadra is a CE-Marked positron emission tomography/computed tomography (PET/ CT) scanner that is designed for clinical use as well as translational. It has an extended 106 cm axial field of view (FoV).

The C12MPG Gemini Series 12MP Large Format Diagnostic Monitor, a color LED backlit LCD, doubles the resolution and eliminates the gap between screens in multi-head display configurations.

The TechGate MRI entryway system is deployed via remote control to provide immediate physical restriction of access to unauthorized individuals, allowing technologists to focus on care of patient and efficient room turnaround.

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Radioembolization Microspheres Treat Hepatocellular Carcinoma

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selective internal radiation therapy (SIRT) platform delivers radioactive glass microspheres directly to liver tumors, with minimal exposure to surrounding healthy tissue. Boston Scientific (Natick, MA, USA; www.bostonscientific.com) TheraSphere treatment is a low toxicity SIRT comprised of millions of microscopic glass beads containing yttrium (Y-90) that are delivered to a Hepatocellular Carcinoma (HCC) through a catheter placed into the hepatic artery, which provides the main blood supply to the HCC. The microspheres, which are unable to traverse the tumor vasculature, are embolized within the tumor, exerting a local beta radiation radiotherapeutic effect, as the average range of the radiation in tissue is 2.5 mm, with a maximum range less than one centimeter. TheraSphere is available in three dose sizes, each supplied with an administration set consisting of a single use, pre-assembled vial with inlet and outlet lines that facilitate infusion of the microspheres to the catheter. Each milligram of TheraSphere contains between 22,000 and 73,000 microspheres of Y-90. The treatment does not require hospitalization, and is typically performed as an outpatient procedure in as little as an hour. TheraSphere has been approved by the FDA after almost 20 years of humanitarian exemption device (HDE).

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Image: A vial of Thera-Sphere contains millions of microscopic glass beads containing yttrium (Photo courtesy of Boston Scientific)

“The FDA approval will expand access to TheraSphere, which has demonstrated improvement in both survivability and quality of life through 20 years of clinical trials and real-world outcomes in the more than 70,000 patients globally,” said Peter Pattison, president of interventional oncology and peripheral interventions at Boston Scientific. “We expect to continue to focus our efforts on bringing this treatment  Cont’d on page 15

Siemens’ USD 16.4 Billion Acquisition of Varian Forges Cancer Treatment Powerhouse

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with the “Upgrading” phase of Siemens strategy. Siemens Healthineers (Erlangen, Germany; www.siemens-healthineers.com) and Varian Medical Systems (Palo Alto, CA, USA; www. varian.com) are building on the long-standing strategic partnership called “EnVision” to establish a comprehensive digital, diagnostic and therapeutic ecosystem that includes treatment management. With Varian, Siemens will leverage AI-assisted analytics to advance the development and delivery of data-driven precision care and redefine cancer diagnosis, care delivery and post-treatment survivorship. Through early and accurate detection as well as more efficient diagnosis, increased treatment quality and access, Siemens will support and acceler-

ate Varian’s mission to reduce uncertainty for cancer patients and increase the level of cancer survivorship. “With the completion of this transaction, we are now best-positioned to take two leaps together: a leap in cancer care and a leap in our impact on healthcare overall. Together, we are establishing a strong and trusted partner capable of supporting customers and patients along the entire cancer care continuum as well as through all major clinical pathways,” said Dr. Bernd Montag, CEO of Siemens Healthineers AG. “Through the transformative combination of Varian and Siemens Healthineers, our united company will address the growing need for personalized, data-driven diagnosis and precision cancer care that enables us to fight back against globally increasing cancer rates,”

said Chris Toth, CEO of Varian, a Siemens Healthineers company. “By bringing together our unique and highly complementary portfolios and capabilities, we will support oncology clinicians and patients in achieving better outcomes and move even closer to achieving our vision of a world without fear of cancer.” In a related development, it was reported that Siemens Healthineers is considering the sale of the ultrasound segment of its imaging division. A number of private equity funds are said to be interested in acquiring the segment which is valued at around USD 1 billion. According to the company’s latest annual report, rising demand for ultrasound systems to diagnose and monitor COVID-19, failed to offset the overall decline in routine and elective procedures due to the pandemic during the past year. HospiMedica International May-June/2021

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Medical Imaging

Wireless Handheld Scanner Extends Ultrasound’s Reach

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cutting-edge, wireless, pocket-sized ultrasound scanner provides crystal clear image quality, whole-body scanning capabilities, and intuitive software. The GE Healthcare (GE; Little Chalfont, United Kingdom; www. gehealthcare.com) Vscan Air is an ultra-compact device that delivers high-intensity ultrasound signals, allowing both shallow and deep exams to be completed effortlessly with a simple flip of the two-sided probe, one side with a high frequency linear probe, and the other with a convex transducer probe, without the need to switch probes in-between or during clinical exams. Proprietary SignalMax technology offer crystal clear imaging capabilities, including for whole-body scanning. Additional benefits include an intuitive user interface, with software presets for fast scanning, a single-button for easy image capture and freezing, and intuitive set-up and scan start-up so users can pair Image: The GE Healthcare Vscan Air probe and app (Photo courtesy the probe and start scanning immediately. DICOM protocols connect of GE Healthcare) the scanner to the hospital’s picture archiving and communication system (PACS) and upload images seamlessly; auto-anonymized images can be seamlessly shared with patients post-scan. The probe also meets a high, military-grade durability standard, withstanding droplets, water exposure, extreme temperatures, and high-level disinfection techniques. “We pioneered handheld ultrasound when we brought the first pocket-sized ultrasound with color Doppler to market, and now we see Vscan Air as delivering on the future of healthcare at a time when ultrasound has proven to be an essential tool at the point of care,” said Anders Wold, President and CEO of Global PRINT MAGAZINE Ultrasound at GE Healthcare. “Now, more than ever, clinicians need smaller and smarter tools that increase access and efficiency both INTERACTIVE in and outside of the four walls of the hospital. DIGITAL EDITION The Vscan Air exemplifies customer-driven inWEB PORTAL novation that enables more personalized care ENGLISH • SPANISH for patients worldwide.” The exponential growth of point of care ultrasound in the intensive care unit (ICU) and hospital clinical wards has been driven by mounting clinical evidence showing heightened patient safety and less risk of complication when key interventions are performed with ultrasound guidance at the point of care, such as imaging the abdomen, heart, and lungs, and when guiding interventional procedures, such as nerve blocks and targeted injections.

PREMIER MULTIMEDIA PLATFORM SERVING THE WORLD’S HOSPITAL / MEDICAL COMMUNITY Anytime, Anywhere, On the Go...

Radioembolization Microspheres Treat Hepatocellular Carcinoma

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to more patients, as well as further investigating the therapy for different cancer segments, including prostate and brain.” As healthy liver tissue is mainly perfused by the portal vein, and most liver malignancies derive their blood supply from the hepatic artery, trans-arterial radioembolization (TARE) using radioactive Yttrium radioactive glass microspheres can be selectively administered to the tumors. The microspheres lodge in the small vessels of the tumor (embolization), emitting localized RT to targeted segments, results in tissue necrosis. The Y-90, with a half-life of 3.85 days, decays to Zirconium-90.

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MOBILE VERSION DAILY CLINICAL NEWS

­­ PRINT MAGAZINE • INTERACTIVE DIGITAL EDITION WEB PORTAL • MOBILE VERSION • MOBILE APPS E-NEWSLETTER • E-MAIL MARKETING ONLINE SOLUTIONS • SHOW DISTRIBUTION

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EMERGENCY BLOOD TESTING NOVA BIOMEDICAL

RESUSCITATOR HERSILL

AUTOMATED EXTERNAL DEFIBRILLATOR (AED)

The EMS™ Stat Data Link is a portable system that measures lactate, hematocrit, hemoglobin, glucose, and ketone from capillary blood drop. Results are available in seconds using single-use biosensors and portable meters.

The REVIVATOR Plus adult manual resuscitators offer easy handling, high touch sensitivity and durability. The 360º rotation freedom of the mask and patient valve allows comfortable ventilation from any position.

The A16 portable and automated external defibrillator (AED) for pediatric/adult use allows for semi-automatic or fully automatic operations. Weighing at 1.97 kgs, it has fast shock delivery time and is easy to operate.

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Hydrophilic Catheter Promotes Discrete Bladder Drainage

new intermittent catheter helps women who use them void comfortably and with a high level of discretion. The Hollister (Libertyville, IL, USA; www.hollister.com) Infyna Chic is a ready to use, disposable, 13 cm long catheter with a Nelaton tip that is available in four color-coded channel sizes (8, 10, 12, and 14 F). The hydrophilic catheter is designed to be lubricated when in comes into contact with sterile water or a saline solution, which eases friction on the urethra upon insertion. Catheter stiffness has been designed to support easy, one-handed, touch-free insertion. The Infyna Chic comes enclosed in a pink pearlescent polypropylene carrying case. The disposable case also features a unique flip cap that is easy to open and close with just one hand, and does not leak when reclosed after use. The single use case and catheter are supplied in boxes containing 30 catheters each. When needed, a standard collection bag can be attached to the catheter, even without removing it from the case. “At Hollister, we understand how important discretion is for women who use intermittent catheters. We are thrilled to address this need by bringing our discreet, beautiful and easy to use Infyna Chic catheter to the US market,” said Abinash Nayak, vice president Americas for Hollister Incorporated. “We look forward to continuing to deliver innovative solutions that help make life more rewarding and dignified for people who use our products and services.” Women with neurogenic bladder disorders like spinal cord injury, spina bifida or multiple sclerosis, and those with other bladder disorders

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MEDIANA

such as urethral strictures or post-operative urinary retention, need to be continuously catheterized to empty their bladders to avoid potential urinary tract infections (UTIs). Image: The Infyna Chic intermittent catheter in pink (Photo courtesy of Hollister)

Spot Check Monitor Improves Patient-Centric Care

record (EMR) systems, and can also connect to a unit’s central monitoring system (CMS), allowing nursing staff to monitor patient data from spot check and continuous monitoring at the same time, anywhere. The Mindray Medical (Shenzen, China; www.mindray.com) VS9 vital signs monitor is designed to unlock the full potential of routine observations, from inpatient admissions and on to spot checks, displaying all monitoring parameters on a vivid, 10.1” touch monitor. Non-invasive blood pressure (NIBP) values are taken in just 15 seconds using patented Mindray TrueBP technology, with respiration rate (RR) detected from a SpO2 finger sensor powered by the TrueResp algorithm. In addition, an ARTEMA Sidestream sensor measures CO2 levels with a 50 ml/min sampling rate, and optional temperature monitoring using the SmarTemp, Genius 3, Exergen TemporalScanner, and HeTaiDa thermometers is available. An integrated automated early warning score (EWS) solution provides customizable escalation messages to support timely clinical

interventions. The patient’s EWS scores can also be integrated into the CMS dashboard, allowing clinicians to monitor patient status in a comprehensive manner. Swapping and switching between parameters, workflow profiles, and assessment tools, enables a flexible, fully customizable range of observation profiles to fit different patient groups, departments, or clinical tasks. In addition, the Mindray M-IoT device manager provides detailed status and diagnostics of all Mindray vital signs devices and other Mindray products across the hospital setting, maximizing the clinical efficiency of installed devices. “Every feature of the VS9 has been designed to allow caregivers to do more, in less time,” said Jim Roberts, marketing manager for Mindray in the United Kingdom. “The VS9 is uniquely suited to help hospitals align with this target, by providing custom workflow profiles for different rounds, extensive manual parameters, and rapid vitals that can be seamlessly uploaded and reviewed as part of a connected workflow.” HospiMedica International May-June/2021

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Bronchial Rheoplasty System Targets Chronic Bronchitis

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novel electrosurgical system delivers non-thermal pulsed energy to the airways to improve the cough and mucus symptoms of chronic bronchitis. The Gala Therapeutics (Menlo Park, CA, USA; www.galathera peutics.com) RheOxh system is comprised of an ablation catheter that targets the cells responsible for mucus hypersecretion in the airways, and a complementary minimally-invasive bronchoscopic procedure to deliver the catheter to the lungs. Once in place, the RheOx catheter delivers short bursts of high frequency, short duration electrical energy to the inner walls of the bronchi, causing the mucus-producing cells to break open and die. Within days, the abnormal cells in the airway epithelium and sub-mucosal tissue layers are replaced by new cells, which produce less mucus and improve the cough response and mucus symptoms of chronic bronchitis. The treatment involves two sessions delivered under general anesthesia. The right lung is treated during the first treatment session and the left lung is treated at the second treatment session, approximately one month later. “Patients with Chronic Bronchitis suffer daily with mucus hypersecretion and cough. We developed the Bronchial Rheoplasty procedure to directly treat the abnormal airway cells responsible for chronic bronchitis, which are not impacted by inhaled medications,” said Jonathan Waldstreicher, MD, CEO of Gala Therapeutics. “This is a significant milestone towards bringing a breakthrough therapy to millions of chronic bronchitis patients in the United States.” “Chronic bronchitis is a debilitating disease which results in symptoms that impact quality of life which commonly persist following guideline based medical treatment,” said Professor Frank Sciurba, MD, of the University of Pittsburgh (PA, USA). “Prior feasibility study results suggest that bronchial rheoplasty using RheOx

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Image: The RheOx bronchial rheoplasty system (Photo courtesy of Gala Therapeutics)

COVID Vaccine May Cause False Positive Mammograms

new study suggests that axillary adenopathy identified on mammography following coronavirus disease (COVID-19) vaccination is becoming more common. Researchers at Massachusetts General Hospital (MGH; Boston, USA; www.massgeneral.org) and Harvard Medical School (HMS; Boston, MA, USA; https://hms.harvard.edu) found unilateral axillary adenopathy that was ipsilateral to recent (prior six weeks) vaccination was on the rise. The adenopathy was benign, however, with no further imaging indicated if no lymphatic nodes were palpable six weeks after the last dose of vaccination. The researchers also suggested a pragmatic management approach for screening mammography, screening MRI, and diagnostic imaging work-up of breast symptoms. For patients with palpable axillary adenopathy in the setting of ipsilateral recent vaccination, a clinical follow-up of the axilla is recommended. In all these scenarios, axillary ultrasound is recommended when clinical concern persists six weeks after vaccination. In patients with recent breast cancer diagnosis in the pre- or peri-treatment setting, prompt recommended imaging is encouraged, as well as vaccinating the patient in the thigh or contralateral arm. The recommendations are intended to reduce patient anxiety, provider burden, and costs of unnecessary evaluation of enlarged nodes in the setting of recent vaccination, and avoid further delays in vaccinations and breast cancer screening during the pandemic. “Radiologists’ communication with clinicians and patients should stress the importance of avoiding delays in either vaccinations or recommended imaging tests to ensure their optimal care throughout the pandemic,” said lead author Professor Connie Lehman, MD, PhD, chief of breast imaging at MGH. “Our practical management plan extends the impact of our recommendations to the full spectrum of patients having imaging tests after vaccination. Advanced planning can support our patients to feel confident and safe to receive their

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is well tolerated, reduces symptoms, and may significantly improve quality of life for patients.” Chronic bronchitis is the most common subtype of chronic obstructive pulmonary disease (COPD), and is associated with increased cough, excessive phlegm and shortness of breath for more than three months of each year. It mainly affects smokers and former smokers, but secondhand smoke, vaping, exposure to airborne chemicals, pollution, and other irritants can also contribute to the disease. Despite treatment with inhalers, many patients have persistent symptoms.

HospiMedica International May-June/2021

vaccinations as well as undergo recommended imaging in their usual care.” Clinically detected axillary and supraclavicular lymphadenopathy was reported in 1.1% of the Moderna COVID-19 vaccine recipients, and in 0.3% of Pfizer-BioNTech COVID-19 vaccine recipients within 2-4 days after vaccination.

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HEART-LUNG SUPPORT SYSTEM

ECG MACHINE

RESPIRATORY HUMIDIFIER

The Cardiohelp System is a small, lightweight and highly portable heart-lung support system suitable for all indications requiring extracorporeal circulation for cardiopulmonary support.

The FCP-8100/FX-8100 resting electrocardiograph machine weighs only 1.2 kg but enables superior performance and allows a wide range applications. Its large 7-inch widescreen LCD offers ease of use for checking patient data.

The NF5 high flow heated respiratory humidifier uses smart temp and humidity monitoring and closed-loop feedback mechanism to provide patients with accurate high-flow nasal O2 therapy (HFNC).

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Exoskeleton Orthopedic Casts Form-Fit Human Anatomy

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hygienic, fully custom, and breathable orthosis provides a better solution for healing broken bones than existing casting and splinting technologies. ActivArmor (Pueblo, CO, USA; www.activarmor.com) is a custom fabricated, 100% recyclable ABS plastic cast for immobilizing the thumbs, fingers, hands, wrists, arms, and lower limbs. The proprietary manufacturing process starts with an optical scan (precise to 0.5 mm) that creates a three-dimensional (3D) model of the patient’s limb. A 3D printer then fabricates a completely individualized and fitted splint, based on the physician’s specific instructions and each patient’s unique needs. The clamshell sections of the cast are locked into place to form a lattice-like structure. Benefits of the custom made cast include an exact fit that allows the tissues to remain in the desired position for optimal rest and healing; a custom design that allows doctors the freedom to immobilize or free-up specific areas, which is not possible with prefabricated devices; observation of skin condition through the lattice frame; water safety that allows the patinet to bathe or swim without concern for the device losing its ability to provide support; and reduced need for maintaining product inventory and/or storage of prefabricated devices. ActivArmor casts comes in a variety of colors. “The products are made from one hundred percent ABS, which is the same plastic as Legos. They’re tested for biocompatibility, microporosity, et cetera, so they don’t trap moisture against the skin, so they’re completely hygienic,” said Diana Hall, President and COO of ActivArmor. “You can wash, bathe, and shower like normal. It’s about

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continuing your active lifestyle while healing, while being immobilized. If you need a splint later in the healing phase, this transitions to a removable splint.” Traditional casts are a shell, frequently made from plaster or fiberglass that encase a limb or other parts of the body to stabilize and hold anatomical structures, most often broken bones, in place until healing is confirmed. Advantages of plaster casts include accurate molding for a snug and more comfortable fit. The major disadvantage is that the limb is unreachable during treatment; skin becomes dry and scaly; and cutaneous complications abound. In hot weather, staphylococcal infection of the hair follicles and sweat glands can lead to severe and painful dermatitis. Image: Exoskeleton Orthopedic Casts Form-Fit Human Anatomy (Photo courtesy of ActivArmor)

Image Processing Software Detects Ischemic Stroke

flow (CBF) abnormality, and correlation with the mismatch in volume and ratio; providing an arterial input function/venous output function (AIF/VOF) graph; and providing insights into the perfusion state of the tissue through perfusion maps. The analysis provides color-coded segmentation, and also includes information on the correctness of the selected arterial input function and the quality of the output. Both the report and the perfusion maps can be delivered directly to the picture archiving and communication systems (PACS) and to and e-mail inbox. The automated assessment of tissue parameters in an acute clinical setting can improve patient outcomes and care by ensuring they get the right treatment (thrombectomy, blood thinners, etc.) in a timely manner.

“With the launch of icobrain cva we address a persisting need in the treatment of acute ischemic stroke,” said Wim Van Hecke, CEO of icometrix. “By democratizing advanced CT perfusion analysis for healthcare systems worldwide, we take the next step in our mission to become a holistic brain solution provider.” Rapid and effective revascularization is the mainstay of acute ischemic stroke treatment. Until recently, intravenous recombinant tissue-type plasminogen activator (r-tPA) was the only established therapeutic option. New studies have proven the benefit of endovascular treatment, and thrombectomy with stent retrievers is now recommended as the standard of care for acute ischemic strokes with a proximal large vessel occlusion in the anterior circulation. HospiMedica International May-June/2021

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Critical Care

Wearable Sensor Monitors Newborn’s Bilirubin Levels

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new study describes a neonatal colorimetry-based device that provides real-time detection of jaundice and simultaneous sensing of vital signs. Developed at Yokohama National University (YNU; Japan; www. ynu.ac.jp) and the National Institute of Health Sciences (NIHS; Kawasaki, Japan; www.nihs.go.jp), the wearable transcutaneous bilirubinometer is composed of a flexible polydimethylsiloxane (PDMS) three-dimensional (3D) printed lens formed over light emitting diodes (LEDs) and oxygen saturation (SpO2) and heart rate (HR) photo detectors. The lens, integrated circuits to control and process tasks, and a coin cell battery supply are held in a blackened PDMS and Ecoflex structure. The sensing part of the device contacts the neonate’s forehead. In clinical experiments on 50 babies, the device demonstrated the possibility of simultaneous detection of bilirubin, SpO2, and HR, and could consistently measure bilirubin during phototherapy; however, the device was not accurate enough to suffice for clinical decision-making. According to the researchers, the results show the potential of a future combined-treatment approach that automaticly links between the wearable bilirubinometer and a phototherapy device for optimization of neonatal jaundice treatment. The study was published on March 3, 2021, in Science Advances. “We have developed the world’s first wearable multi-vital device for newborns that can simultaneously measure neonatal jaundice, blood oxygen saturation, and pulse rate,” said senior author Hiroki Ota, PhD, of the YNU Department of Mechanical Engineering, and colleagues. “The real-time monitoring of jaundice is critical for neonatal care. Continuous measurements of bilirubin levels may contribute to the improvement of quality of phototherapy and patient outcome.”

Radioactive Cement Safer For Spinal Tumor Treatment Cont’d from cover

Spine-Rad brachytherapy cement includes radioactive isotopes that are dispersed evenly, so that radiologists don’t need to measure the total amount of radioactivity; the dose delivered to the tumor is independent of the volume of cement and the amount injected. To validate the function of the cement, the researchers conducted animal and computational studies to evaluate the short-term efficacy, safety, migration of radioactivity into blood, urine, or feces; and the radiation dose from phosphorus-32 (P-32) emissions to the spinal cord and soft tissues. The results showed that at 17 weeks post-injection, physical examinations were all normal, and no activity was detected in blood, urine or feces. The researchers found no evidence of the P-32 isotope in the circulating blood, no changes in blood work related to radioactivity, no neurological deficits, and that radiation dose rates outside the injection site were minimal. The study was presented at the annual meeting of the Orthopaedic Research Society, held virtually during February 2021. “Currently, multiple sessions of external beam radiation are used to treat cancer that has spread to the spine. But with the brachytherapy bone cement, a single injection can provide an equivalent, targeted tumor treatment with significantly less threat to the spinal cord and nerves,” said senior author and study presenter Professor Joyce Keyak, PhD. “You can have this procedure and be done with it. And you can do it when tumors are smaller to prevent further bone and spinal cord damage, while limiting the pain and side effects that patients often feel.” Cancers that begin in the breast, prostate, lung, thyroid and kidney can spread to the vertebrae and weaken them while causing pain to the patient. Gamma radiation therapy to kill the tumor is toxic to bone, spinal cells and nerves, leading to paralysis. Because of this, RT is often delayed in patients with metastatic cancer as long as possible, leaving them in pain as tumors progress.

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Neonatal jaundice is a physiological phenomenon caused by hemoglobin in the prenatal fetus which is rapidly broken down into bilirubin after birth. As metabolic capacity of the neonate liver is immature, it cannot process large amounts of bilirubin, leading to hyperbilirubinemia; excess bilirubin is deposited in the skin, turning it yellowish. Hyperbilirubinemia can also cause deposition in the basal ganglia, resulting in neurologic dysfunctions such as mental retardation, athetotic cerebral palsy, sensorineural deafness, and upper gaze paralysis. To combat the jaundice, blue light phototherapy is administered, transforming the bilirubin into a hydrosoluble photoisomer that can be easily excreted in urine. Image: A wearable transcutaneous sensor measures bilirubin levels in babies (Photo courtesy of Ota Hiroki/ YNU)


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AUGMENTED REALITY SURGICAL ALL-IN-ONE ENDOSCOPE SYSTEM PHILIPS AMBU NAVIGATION

The ClarifEye Augmented Reality Surgical Navigation to advance minimally-invasive spine procedures is an image-guided therapy solution combining imaging and augmented reality (AR) navigation into one system.

TELE PACK+ is an ALL-IN-ONE system that combines a monitor, LED light source, FULL HD camera control unit and documentation with integrated network function in a portable and compact unit.

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BENQ MEDICAL TECHNOLOGY

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3D-Printed Guides Aid Breast Conservation Surgery

D printed-breast surgical guides (3DP-BSG) can help delineate the tumor area during breast-conserving surgery (BCS), according to a new study. Developed at Asan Medical Center (AMC; Seoul, Korea; http://eng. amc.seoul.kr) and Gyeongsang National University Changwon Hospital (Republic of Korea; www.gnuch.co.kr/gnuh), the 3DP-BSG are to mark the safety excision margin, 0.5 cm outside of the tumor edges. Fabricates using supine magnetic resonance imaging (MRI) scans and 3D images, the guide fits on the surface of the breast and includes a hole at the nipple, with direction markers indicating the opposite nipple and the suprasternal notch to prevent rotation. The digital model is exported to a 3D printer in a stereolithography (STL) file format. To test their accuracy and efficacy, the guides were used in a prospective study that included 39 patients who underwent BCS and neoadjuvant systemic therapy (NST). Overall, tumor-positive resection margins were found in four patients (10.3%), compared to the 40% rate of tumor-positive margins reported in the literature. Over a three-year follow-up, three (7.7%) of the patients suffered recurrent breast cancer, compared with the five-year 12.1% local recurrence rate reported in literature. The study was published on February 9, 2021, in Scientific Reports. “By using 3D-printed breast surgical guides as a localization method in patients receiving neoadjuvant systemic therapy, it is possible to precisely target the original tumor area observed in the pretreatment MRI,” concluded senior author Beom Seok Ko, MD, of AMC, and colleagues.

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SURGICAL LIGHT

“The advantages of the method are that it is painless, does not include radiation, and does not increase the procedure time. In addition, it allows for the preservation of normal breast tissue and precise tumor removal, enhancing the cosmetic effect.” Several localization methods have been used to remove tumors that are challenging to identify with breast palpation alone. The most commonly used method, wire localization, may be associated with complications such as vasovagal syncope and pneumothorax, leading to problems during surgery like migration, cutting, and loss. Newer localization methods, such as radio-guided occult lesion localization (ROLL) and radioactive seed localization have also been developed due to the limitations of WL, and have been useful in BCS patients who underwent NST. Image: (A) MRI-based 3DP-BSG modeling; (B) Marking on the skin surface using 3DP-BSG and targeting the tumor inside the breast by injecting blue dye; (C) After removal of the guide. (Photo courtesy of AMC)

Patient Specific Talus Spacer Treats Avascular Necrosis

n additively manufactured patient specific implant allows patients suffering from avascular necrosis (AVN) to regain motion and reduce pain in the ankle. The Additive Orthopaedics (Little Silver, NJ, USA; www.additiveorthopaedics.com) Patient Specific Talus Spacer is a three dimension (3D) printed implant that is designed to provide a joint-sparing alternative to other surgical interventions commonly used in late-stage AVN that may disable motion of the ankle joint. Constructed of a porous lattice structure in order to support bony in-growth, the advanced talus implant includes complex geometries that lead

to enhanced osteointegration, which are not possible with traditional manufacturing processes. The Patient Specific Talus Spacer is 3D printed for each patient individually, modeled from a computed tomography (CT) scan, and is fitted to the patient’s specific anatomy. During the replacement surgery, the patient’s talus bone is removed and replaced with the implant, which is made from cobalt chromium alloy. While fusion may become necessary in the future (should the condition worsen), the Additive Orthopaedics Talus Spacer provides a joint-sparing procedure, as it allows the patient to retain motion in the ankle joint.  Cont’d on page 21

Image: The 3D printed Patient Specific Talus Spacer (Photo courtesy of Additive Orthopaedics) HospiMedica International May-June/2021

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Robotic Digital Microscope Aids Image-Guided Surgery

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n innovative digital surgical microscope allows neurosurgeons to see more, assisted with a robotic arm to position the camera conveniently. The Aesculap (Tuttlingen, Germany; www.aesculap.de) Aeos platform includes a digital microscopic mounted on a multi-axis robotic arm to enable surgeons to execute precision movements in a range of procedures, including neurosurgery, spine, ENT, and more. Powered by True Digital Surgery (TDS; Goleta, CA, USA; www.truedigitalsurgery.com), Aeos augments 3D optics via state-of-the-art algorithms that enable the surgeon to customize the image to match that of an optical microscope, but through a headsup display that can be viewed simultaneously on 55” 4K monitor. Features include a 1:10x zoom ratio, a working distance of 20-45cm, reliable lock-on-target features, and robotically assisted motion and stability. Image and personalized control settings, once derived, may be saved with a push of a button, allowing faster Image: The Aesculap Aeos Robotic Digital Microscope (Photo courworkflow set-ups. The platform also allows for surgical tools, such tesy of Aesculap) as endoscopes, to be integrated into the system. As an option, the RS Aesculap Aeos can import images generated by CT or MRI scanTO LY IBUO APP R T ners in standard DICOM format, so that they can be displayed in T DIS TED I INV real-time in picture in picture (PIP) or side by side format. A wide range of image modes includes built-in 3D near-ultraviYOUR GLOBAL SOURCE FOR STERILIZATION ACCESSORIES olet (nUV) illumination and visualization with augmented reality (AR) overlays, as well as 3D digital near-infrared (DIR) illumination THERMO for effective background visualization, which aids identification of RESISTANT nearby non-fluorescing structures, without the need to switch back GLOVES to white light. All images, including nUV and DIR augmentations, can be displayed in high-quality live view and slow motion playUp to 37 cm back on multiple 3D 4K monitors. in length “This platform was developed with True Digital Surgery’s unmatched experience in 3D visualization and vivid imagery, STERILIZABLE INSTRUMENT coupled with the invaluable insights and global sales and support & WORK-SURFACE MATS TURBO WASHING capabilities gained from our strategic partnership with Aesculap,” Thermo-Resistant (-60 °C to 300 °C) MACHINES TRAYS said Aidan Foley, Chairman and CEO of TDS. “We like to say we Fully Washable & Flexible can see beyond the tissue and provide a solution to the limitations Suitable for central sterilization services of conventional surgical microscopes, especially during this chalSterilizable Heavy Silicone Cover & Transport Tablet lenging time for the global medical community.” “Together with True Digital Surgery, we have developed such SILICON INSTRUMENT MAT MICRO INSTRUMENT MAT an innovative solution with the new Aesculap Aeos,” said Andreas Front Back Knapp, vice president of global marketing and R&D neurosurgery and power systems at Aesculap. “We are pleased to market this fully digital surgical microscope platform globally, fulfilling the most important requirements of our surgeons with regards to superior WASHING TRAYS MAT WASHING TRAYS MAT visualization capabilities, robotic-assisted positioning and improved ergonomics.”

Patient Specific Talus Spacer Treats Avascular Necrosis

cont’d from page 20

“Avascular necrosis of the talus is extremely painful and debilitating for these patients. The Patient Specific Talus Spacer is another example of how 3D printed devices can improve the standard of care,” said Greg Kowalczyk, President of Additive Orthopaedics. “Surgical treatment options are below-the-knee amputation or joint fusion, which results in loss of motion of the ankle, and can have poor outcomes.” AVN of the ankle joint is a serious and progressive condition that causes death of bone tissue stemming from a lack of blood supply to the area. It is often caused by a sudden injury--such as a broken bone or a dislocated joint--or sustained damage to the tissue that develops over time, causing the damaged bone to turn necrotic. When a joint is affected, such as the ankle, the cartilage also deteriorates, leading to arthritis and pain. Late-stage AVN of the ankle may result in the talus partially or fully collapsing.

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OPERATING TABLE

SMOKE EVACUATION SYSTEM

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The Famed OPTIMA (5.15) operating table can be controlled through the remote control and locked in place easily. while modular tabletop segments can be exchanged to suit the current case or use a full potential of 350kg of max load.

The IES 3 smoke evacuation system eliminates 98.6% of the smoke with evacuation 1 cm directly above the source. Its ULPA-15-filter removes 99.9995% of the 0.1 μm particles in the operating room for a safe working environment.

The XLT-85F LED surgical headlamp has an illumination spot that provides 85,000 Lux with a fixed 2 inch diameter (measured at 14”), bringing light to the areas you need to see

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Artificial Spinal Prosthesis Reconstructs Cervical Discs

n innovative disc prosthesis restores disc height and maintains segmental motion in the cervical region of the

spine. The Spineart (Geneva, Switzerland; www. spineart.com) Baguera C cervical disc prosthesis is designed to maintain the natural behavior of a functional spinal unit by restoring segmental motion and disc height in the cervical spine, following a single-level or two-level discectomy procedure for symptomatic cervical disc disease. The prosthesis, which is made of two titanium plates interconnected by a polyethylene (PE) central core, permits the patient to experience controlled neck mobility in all six degrees of freedom, with independent angular rotations and translational motions. A sloping anatomical design optimizes fit between the implant and disc space in order to maximize end-plate coverage, with an additional three upper and three lower fins to enhance primary and secondary stability. The

guided mobile PE core prevents excessive constraints on the facet joints and significantly lower contact pressure distribution. In addition, the dual titanium plates are coated with Diamolith, a diamond-like-carbon (DLC) product that reduces artifacts under magnetic resonance imaging (MRI), for better postoperative control. Baguera C has received the Euroean Unin CE Mark of approval, and is undergoing a FDA investigational device exemption (IDE) clinical trial. “The enrollment of the first patient in our Baguera C two-level trial in the United States is an important achievement, made possible by the relentless work of our employees and partner surgeons,” said Jerome Trividic, President of Spineart USA. “We have embarked on an ambitious project to gather additional solid scientific evidence of safety and effectiveness for our Baguera C artificial disc, with the ultimate goal of providing spine surgeons in the U.S. and their patients with new treatment options.”

Disc replacement via arthroplasty has become a common surgical option for treatment of degenerative cervical disc pathologies, and is considered to be a viable alternative to anterior cervical discectomy and fusion (ACDF). The implanted artificial disc functions similar to a joint, allowing for flexion, extension, side bending, and rotation, thus maintaining motion in the treated vertebral segment. Image: The Baguera C cervical disc prosthesis (Photo courtesy of Spineart)

Software Application Guides Anterior Approach THA

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ew generation distortion-correcting, implant-agnostic, intraoperative-alignment technology aids direct anterior hip total hip arthroplasty (THA) procedures. The OrthoGrid Systems (Salt Lake City, UT, USA; www.orthogrid.com) OrthoGrid Hip is intended to assist precise positioning of THA components intraoperatively by measuring their positions relative to the bone structures of interest, as identified from radiology images, with greater accuracy and efficiency. The software suite features a comprehensive suite of tools, including cup inclination and version tools that enable orthopedic surgeons to target specific acetabular cup positioning and measure acetabular cup inclination and anteversion angles during cup placement.

The AI-enabled guidance technology imports images from C-arms using grids that reveal fluoroscopic distortion, facilitating intra-operative decisions on pelvic pitch, pelvic obliquity, hip offset, acetabular cup position, and leg length in order to achieve the desired biomechanical alignment. An overlay feature is available for surgeons who prefer the overlay technique. OrthoGrid Hip is compatible with all current implant and C-arm manufacturers, and has been shown to decrease surgical time by up to fifteen minutes. “We are thrilled to bring this latest version of our OrthoGrid Hip software to market,” said Richard Boddington, co-founder and co-CEO of OrthoGrid. “The small footprint, noninvasive design, and cost-effective price point make it  Cont’d on page 23 HospiMedica International May-June/2021

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Surgical Techniques

Delaying Gunshot Treatments Diminish Postoperative Morbidity

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new study suggests that delaying surgical intervention following high-velocity maxillofacial injuries can improve healing. Researchers at Galilee Medical Center (GMC; Nahariya, Israel; www.gmc.org.il) and the Azrieli Faculty of Medicine at Bar Ilan University (Safed, Israel; https://medicine. biu.ac.il) conducted a study comparing the number of postoperative complication rates in 60 Syrian patients admitted to GMC over a five-year period (May 2013 to May 2018) for the treatment of high-velocity maxillofacial injuries sustained during the civil war. Patients arriving early (within 24 hours) were compared to those who arriving late (14-28 days). Both groups received definitive surgical treatment within 48 hours of admission. The results showed that postoperative complications in the early group were found to be significantly higher compared to the delayed arrival group, suggesting that the unintentional delay in providing surgical treatment may have contributed to a critical revascularization period (CRP) that resulted in an improved postoperative healing and decreased morbidity and complications. The study was published on January 21, 2021, in Scientific Reports. “While the timing of intervention and the extent to which each step of treatment is applied may be controversial, we believe that allowing sufficient time for CRP is an imperative step for providing optimal treatment outcomes,” concluded lead author Professor Samer Srouji, MD, of Bar Ilan University, and colleagues. “We believe that the benefit stems from neovascularization, the formation and repair over time of blood vessels in the injured region, which improves the supply of blood and oxygen to the area and, in turn, leads to smoother healing and fewer complications following surgery.” Image: A wounded Syrian child hospitalized at Galilee Medical Center (Photo courtesy of GMC)

Software Application Guides Anterior Approach THA

cont’d from page 22

an easy decision for hospitals and surgery centers, as they look to recover from this backlog of elective procedures created by the COVID-19 pandemic.” “I started using OrthoGrid Hip when the first generation came out a few years ago. The technology has allowed me to consistently achieve hip symmetry without interfering with my surgical workflow or adding to my operative or fluoroscopy times,” said Cass Nakasone, MD, of the University of Hawaii (Manoa, USA), and department chief for the bone and joint center at Straub Clinic and Hospitals (Honolulu, HI, USA). “I have been eagerly awaiting the new cup tools and leg length measurement features in this new version.” Fluoroscopy utilizing a mobile C-arm is the most widely used technology for placement and alignment in orthopedics. While fluoroscopy has a positive impact on THA outcomes, image distortion--caused by continuously variable electromagnetic forces (EMF)--can potentially lead to incorrect adjustments. The most prevalent type of distortion is the S-Distortion, which can cause up to 19 mm variation from one side of field of view to the other.

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The Kick EM is a portable, streamlined and minimalistic electromagnetic surgical navigation system consisting of a field generator, connection panel and the Kick monitor cart. Design and easy set up make it ideal for small ORs.

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Adaptable Seal Minimizes Aortic Manipulation During Anastomosis

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novel sealing system minimizes aortic manipulation during on and offpump coronary artery bypass grafting (CABG). The Vascular Grafts Solutions (VGS; Tel Aviv, Israel; www.graftsolutions.com) Viola is a clampless proximal anastomosis system that combines a standard punching mechanism and an adjustable sealing element that accommodates to the aortic wall, creating an optimal seal with minimal bleeding. Viola is also suitable for multiple use, allowing surgeons to create three to four anastomosis with a single unit. The result is protected, clean, and dry proximal anastomosis suturing of the aorta during CABG without partial clamping, which can lead to neurologic complications. “Our vision has always been to advance cardiovascular surgery. We are committed to this long journey and in the last decade, we

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were able to develop solutions that address the biggest unmet needs in CABG, vein graft failure and perioperative neurological complications,” said Eyal Orion, MD, founder and CEO of VGS. “Gradually, our focus will shift from generating high quality science that shows the benefits of our technologies to making our solutions a new standard of care in CABG.” “The Viola has important design features that provide reliable and safe mechanism for constructing clampless proximal anastomoses,” said Professor Gil Bolotin, MD, director of cardiac surgery at Rambam Medical Center (Haifa, Israel). “The integrated punching mechanism, the excellent sealing quality which makes a blower unnecessary, and the ability to perform multiple anastomoses with a single device makes the Viola a very attractive tool in our operating room.”

Atherosclerosis of the ascending aorta is known to be a major source for post-operative stroke and cognitive dysfunction following CABG, since the manipulation of diseased aorta (either by cannulation or cross clamping) can lead to release of atherosclerotic material and calcified plaque that can potentially cause neurologic complications. Clampless proximal anastomosis can help prevent postoperative stroke and neurologic events, especially in patients with high grade aortic stenosis. Image: The Baguera C cervical disc prosthesis (Photo courtesy of Spineart)

Surgical Light Delivers Optimal Illumination Performance new series of surgical lights with high-end features provide surgeons with an enhanced working experi-

ence. The Mediland Enterprise (Kueishan, Taiwan; www.mediland.com.tw) SunLED Series of surgical lights is designed to emulate a cloverleaf, with a graceful, smooth three or four leaves configuration. Thanks to the calibrated precision of angles for each leaf, and precise allocation of multi-light sources and multi-modules, the SunLED mixes the light to achieve optimal optics performance in the operating room (OR). Four intelligent light mode patterns, natural white temperature, and shadowless performance provide a range of settings for different surgical needs. A membrane control panel provides simple operation control, with intuitive control and adjustments via a motorized sterile handle

thatallow the surgeon to conveniently reach up and make quick adjustments. A touch-free gesture control mode grants the surgeon the option to change any mode and light pattern while reducing infection risk and improving hygiene. Thermal management and laminar flow design help fulfill hygiene requirements and prevent radiation heat to the patient, while also ensuring a comfortable work zone around the surgeon’s heads. An optional Full HD Camera system meets imaging demands. “We see the demands of surgical equipment from the rise of diseases globally, and we listen to the feedback from our partnered hospitals. Thus, the new series of products are developed to provide clinicians a more convenient and better operating environment,” said Robin Chen, general manager of Mediland Enterprise. “It is essential to optimize the operating room with technologically advanced equipment for

surgeons to perform surgical procedures with higher efficiency and achieve better surgical outcomes.” The laminar airflow principle is designed to control particulate and microbial contamination in ambient air. In optimal conditions, the entire body of air moves with uniform velocity along parallel flow lines, with a minimum of eddies. Image: The SunLED series of surgical lights (Photo courtesy of Mediland Enterprise) HospiMedica International May-June/2021

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Industry News

Rapid AI Penetration to Drive Growth of Global MR Vital Sign Monitors Market

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surge in cases of chronic obstructive pulmonary disease (COPD) and cardiovascular diseases is encouraging clinicians and manufacturers to develop artificial intelligence (AI)-driven MR vital sign monitors, thereby driving the growth of the global MR vital sign monitors market. These are the latest findings of Fact.MR (Rockville, MD, USA; www.factmr.com), a consulting firm that offers market research reports. MR vital sign monitors measure primary vital signs such as body temperature, blood pressure, heart rate, and respiratory rate. MR vital sign monitors provide accurate as well as fast results to evaluate a patient’s health. The MR Vital sign monitor provides necessary information to healthcare professionals about the patient health condition. The MR Vital signs monitor is used in various healthcare settings such as specialty clinics, hospitals, ambulatory surgical centers, and home setting. The MR Vital sign monitor systems are less expensive as compared to other multi-parameter patient monitor devices and provide a fast and accurate result. MR vital sign monitors’ enables healthcare professional to monitor critical

patients even when the patient is undergoing an MR exam. These advantages of MR vital sign monitors system are driving the growth of the MR vital sign monitors market. The rising prevalence of chronic obstructive pulmonary disease and cardiovascular diseases are the key factors driving the growth of MR vital sign monitors market. Additionally, the increasing geriatric population is considered as a major factor in boosting the growth of the global MR vital sign monitors market. The growing geriatric population is at a high risk of chronic disease indications, fueling the growth of the MR vital sign monitors market. Moreover, a significant increase in health care spending and rising disposable income are expected to boost the MR vital sign monitors market. The integration of monitoring devices with information & communication technology has provided numerous benefits to the patients and thus, efficient in promoting healthcare at home. However, the government’s stringent regulations in low middle-income countries may hinder the growth of the global MR vital sign monitors market. The adoption of advanced technology and

ZOLL Acquires Sleep Apnea Treatment Developer

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OLL Medical Corporation (Chelmsford, MA, USA; www.zoll.com), an Asahi Kasei company, has acquired Respicardia, Inc. (Minnetonka, MN, USA; www.respicardia.com), a provider of novel implantable neurostimulators for the treatment of moderate to severe Central Sleep Apnea (CSA). CSA occurs when the brain fails to send appropriate signals to the breathing muscles that stimulate a regular breathing pattern. Respicardia’s remedē System is a revolutionary treatment for CSA, and is the only implantable device approved by the US Food and Drug Administration (FDA) to treat moderate to severe CSA in adult patients with reduced cardiac function. Implanted by a cardiac electrophysiologist during a minimally invasive outpatient procedure, the remedē System delivers electrical pulses to one of the phrenic nerves, which

H

send signals to the diaphragm, restoring a more normal breathing pattern during sleep. ZOLL, which develops and markets medical devices and software solutions that help advance emergency care and save lives, has been a significant investor in Respicardia for more than three years. With products for defibrillation and cardiac monitoring, circulation enhancement and CPR feedback, supersaturated oxygen therapy, data management, ventilation, and therapeutic temperature management, ZOLL provides a comprehensive set of technologies that help clinicians, EMS and fire professionals, as well as lay rescuers, improve patient outcomes in critical cardiopulmonary conditions. “ZOLL and Respicardia both develop innovative therapies for conditions with large unmet clinical needs, and we share a deep commitment to improving patient outcomes,”

said Jon Rennert, CEO of ZOLL Medical. “With this acquisition, ZOLL will combine its expertise in cardiac and respiratory care with Respicardia’s novel remedē System to make a meaningful difference in the health and quality of life for many patients.” Image: Respicardia’s remedē System (Photo courtesy of Respicardia, Inc.)

Hillrom Expands in Ambulatory Cardiac Monitoring

illrom (Chicago, IL, USA; www.hillrom.com) has agreed to acquire Bardy Diagnostics (BardyDx; Seattle, WA, USA; www. bardydx.com) for a cash consideration of USD 375 million. The acquisition of BardyDx, an innovator in digital health and a leading provider of ambulatory cardiac monitoring technologies, complements Hillrom’s current cardiology portfolio of cardiac stress exercise, Holter and resting electrocardiography (ECG) devices. BardyDx provides a differentiated, wearable bio-sensing technology, the Carnation Ambulatory Monitor (or CAM patch), that is engineered for patient-comfort, superior P-wave clarity, exceptional diagnostic yield and superior clinical accuracy. The CAM patch is designed to promote patient compliance, streamline clinical workflow, and yield clinically actionable data in a unique and proprietary CAM report that enables physicians to identify specific arrhythmias to aid clinical decision-making. The device employs a novel circuit design and uses advanced compression algorithms to process the

25

AI to develop remote MR vital sign monitoring devices is expected to gain immense popularity over the coming years. Strategic collaborations and acquisitions among key manufacturers are playing a vital role in improving their competitive landscape in the market, fuelling the demand. Manufacturers are focusing on developing wireless and wearable vital sign monitors for catering to the demand from hospitals and surgical clinics. Based on product type, COPD and glucose level MR vital sign monitors expected to dominate the market. Geographically, North America is expected to record high revenue growth and hold the highest share of the global MR vital sign monitors market due to advanced healthcare infrastructure and technological advancements in the region, followed by Europe. The Asia-Pacific market will record a moderate growth due to low awareness about important measures related to chronic conditions and a large patient pool. The Middle East & Africa and Latin America markets are expected to record low growth due to their weak healthcare management and facilities, and a high percentage of underserved patient population.

HospiMedica International May-June/2021

signal, ensuring P-wave recording and accuracy, a significant attribute for cardiologists and electrophysiologists. Hillrom’s existing global brand, channel and presence in acute and primary care settings, and capabilities around market access, payor contracting, data security and EMR integration, are expected to drive accelerated adoption of the CAM patch and BardyDx’s related suite of ECG analysis services and tools. “This acquisition provides Hillrom with a highly strategic and differentiated diagnostic cardiology platform aligned with our vision of Advancing Connected Care, as well as an attractive recurring, high-growth revenue stream and gross margin profile,” said Hillrom President and CEO John Groetelaars. “BardyDx brings a talented team with significant commercial, clinical and scientific expertise, and dedicated independent diagnostic testing facilities. We look forward to welcoming the 230 employees who will join us in our mission of enhancing outcomes for patients and their caregivers.”


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