HospiMedica International March 2021

WORLD’S CLINICAL NEWS LEADER Vol.39 No.1 • 2-3/2021

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Robotic-Assisted Solution Simplifies TKR Procedures

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daptable robotic technology utilizes advanced planning capabilities and a next-generation design to help surgeons accurately resect bone during total knee replacement (TKR) procedures.

The DePuy Synthes (West Chester, PA, USA; www.depuysynthes.com)

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Optoacoustic Technology Enhances Breast Cancer Diagnostics

n innovative breast cancer imaging system combines ultrasound (US) and optoacoustics (OA) to help differentiate between benign and malignant breast lesions.

The Seno Medical Instruments (Seno; San Antonio, TX, USA;

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www.senomedical.com) Imagio OA/US system is indicated for use by trained and qualified healthcare providers to evaluate palpable and non-palpable breast abnormalities in adult patients who are referred for diagnostic imaging breast workup, following clinical presentation Cont’d on page 15

AI Algorithm Predicts Mortality Risk for COVID -19 Patients

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CT Radiomics Helps Classify Small Lung Nodules

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machine-learning (ML) algorithm can be highly accurate for classifying very small lung nodules found in low-dose CT lung screening programs, according to a new study.

Researchers at the BC Cancer Research Center (BCCRC; Vancouver, Canada; www.bccrc.ca) trained a linear discriminant analysis (LDA) ML algorithm-using data from the Pan-Canadian

ynamic chest radiography (DCR) holds promise for assessment of tumor invasion and adhesion in the parietal pleura, according to a new study.

Researchers at Kanazawa University (Japan), Duke University (Durham NC, USA), and Yokohama City University (Japan) conducted a proof-of-concept study to investigate the feasibility of preoperative evaluation of pleural invasion/adhesion Cont’d on page 13

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DCR Identifies Pleural Invasion of Lung Tumors

n international research team based in Germany has developed an Artificial Intelligence algorithm called COVEWS, short for “COVID-19 Early Warning System,” which draws on medical data derived from thousands of patients around the world to reliably predict a COVID-19 patient’s risk of dying for up to eight days in advance. HospiMedica’s special COVID19 Update section starts on page 3.

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Clinical Wound Dashboard Elevates Patient Care

n interactive dashboard provides an intuitive cockpit view of wound and patient data sets to deliver more informed wound care.

The Perceptive Solutions (Stevens Point, WI, USA; www. perceptivesol.com) Wound-

Augmented Reality System Advances Joint Arthroplasty

new head-mounted augmented reality (AR) intra-operative system guides joint arthroplasty and hip replacement surgery.

The Surgical Planning Associates (SPA; Boston, MA, USA) HipInsight AR is a surgical guidance

COVID-19 Update. . . . . 3 News Update. . . . . . . . . . 11 Product News . . . . . . . 6-10

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INSIDE

platform that combines cloudbased preoperative planning and real-time interoperative guidance, enabling surgeons to be more precise during the most critical aspects of the procedure. The HipInsight system also provides a seamless and intuitive solution, 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

GLOBETECH >>> MEDIA <<<

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COVID-19 Update

AI Algorithm Predicts Mortality Risk for COVID -19 Patients

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newly-developed algorithm that has been trained with machine learning methods uses COVID-19 as an example to predict patients’ individual mortality risk.

An international team led by researchers at the Max Planck Institute for Intelligent Systems (Tübingen, Germany; www.mpg.de) has developed the algorithm and trained it to predict individual mortality risk for patients with COVID-19 by drawing on the data of thousands of patients around the world. The algorithm that aims to help medical professionals with mortality predictions for COVID-19 patients can also be trained to predict mortality risk for other diseases, and thus support physicians in decision-making processes.

The algorithm called Covews, which is short for COVID-19 Early Warning System, draws on medical data to reliably predict a patient’s risk of dying up to eight days in advance with a sensitivity of more than 95%. This means that in 95 out of 100 cases, the algorithm can detect whether a patient will die unless preventative measures are taken. At the same time, Covews works with a specificity of just under 70% for a prediction eight days in advance, meaning that in about 70 out of 100 cases in which death is predicted, the patients ultimately die. In other words, the algorithm sounds a false alarm in only 30 out of 100 cases and is significantly better for shorter time horizons. The algorithm can also be trained to make less sensitive, but more specific predictions.

To develop and especially to train Covews, the researchers used 33,000 anonymized data records from a cohort called Optum, which tracks patients in various hospitals in the US. They fed the algorithm information about how several routinely collected patient health parameters evolved over the course of the disease, and whether or not the person died from COVID-19. As a result, Covews learned to identify patterns in the data sets that indicated a high risk of mortality. The international team then tested how accurately Covews estimated this risk on about 14,000 other data sets from the Optum cohort. By testing Covews on data from the TriNetX global health network, which includes about 5,000 patients with positive COVID tests in the US, Australia, India, and Malaysia, the researchers showed that the algorithm not only predicts mortality risk with a high degree of certainty with data sets from this cohort, but also with data from other hospitals.

Although Covews makes reliable predictions, it will likely take quite some time before it is used in practice. This is partly because at many hospitals, the available data are not sufficiently structured, making the development of suitable software based on the algorithm particularly challenging. In any case, by making Covews freely available on the internet, the researchers are laying the groundwork for putting the algorithm into practice quickly. Not only could it be used for COVID-19 patients; with the right training, it could also predict mortality risk for other diseases.

“Doctors must thus always decide on treatment measures,” said Stefan Bauer

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of the Max Planck Institute for Intelligent Systems who led the international team of researchers. “However, our algorithm can provide insights that people can’t derive from the data, and that can help with medical decisions.”

Image: Artificial Intelligence Algorithm Predicts Individual Mortality Risk for COVID-19 Patients (Photo courtesy of patrikslezak)

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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 December 1, 2020 till January 31, 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of HospiMedica or visit www.HospiMedica.com.

CTA Scans May Offer Fast and Early Detection of COVID-19 in Stroke Patients Examination of the lungs via computed tomography angiogram (CTA) scans helped researchers at the Albert Einstein College of Medicine (New York, NY, USA; www.einstein.yu.edu) screen for and detect COVID-19 earlier than traditional nasal swab tests in acute stroke patients. In a new study, researchers using CTA scan results in combination with COVID-19 symptom questionnaires were able to detect COVID-19 with 83% accuracy.

Artificial Intelligence Algorithm Analyzes Chest X-Rays to Detect COVID-19 in Seconds A team of researchers at the University of Minnesota (Minneapolis, MN, USA; www. twin-cities.umn.edu) recently developed and validated an artificial intelligence (AI) algorithm that can evaluate chest X-rays to diagnose possible cases of COVID-19. When a patient arrives in the emergency department with suspected COVID-19 symptoms, clinicians order a chest X-ray as part of standard protocol. The algorithm automatically evaluates the X-ray as soon as the image is taken. If the algorithm recognizes patterns associated with COVID-19 in the chest X-ray - within seconds - the care team can see that the patient likely has the virus.

Fujifilm Launches Droplet-Reduction Mouthpiece to Reduce COVID-19 Risk in Endoscopic Examinations FUJIFILM Corporation (Tokyo, Japan; www. fujifilm.com) has launched a new droplet reduction mouthpiece named B1 to potentially increase safety and reduce risks arising from COVID-19 during endoscopy procedures.

The mouthpiece B1 incorporating a sponge rubber, a droplet reduction accessory, and a drape shield specifically created to catch and reduce the droplets emitted by the patient during endoscopic examination of the upper gastrointestinal tract, helps minimize the risk to healthcare workers and fellow patients from becoming infected with COVID-19 and various other pathogens.

Nasally Administered Drug Could Generate Nasal Mucosal Immunity against SARS-CoV-2 Tiziana Life Sciences plc (London, UK; www.tizianalifesciences.com) has initiated

clinical trial with COVID-19 patients in Brazil with nasally administered Foralumab, a fully human anti-CD3 monoclonal antibody that could generate nasal mucosal immunity against SARS-CoV-2 in the respiratory tract and lungs. Nasally administered Foralumab, by acting locally, could potentially suppress excessive cytokine storm and hyperinflammation in respiratory tract and lungs of COVID-19 patients.

Free Artificial Intelligence Software for Rapid Detection of COVID-19 from CT Scans Launched Globally Novarad (Salt Lake City, UT, USA; www. novarad.net) has launched its new COVID-19 AI Diagnostic Assistant worldwide to make fast, accurate diagnosis of COVID-19 possible - free of charge. In partnership with Intel Corp., and leveraging Azure, Microsoft’s cloud computing service, Novarad is offering free use of its diagnostic system that combines DICOM routing, encryption, an AI processing engine, and secure reporting for the detection of COVID-19 from Computed Topography (CT) scans.

Statins Reduce Mortality by 22-25% in COVID-19 Patients A study by researchers from the Universitat Rovira i Virgili (URV Tarragona, Spain; www.urv.cat) and Pere Virgili Institut (IISPV Tarragona, Spain; www.iispv.cat) has found that people who are being treated with statins, a drug that helps to reduce cholesterol in the blood and thus prevent cardiovascular diseases, have a 22% to 25% lower risk of dying from COVID-19.

Although the research was never intended to demonstrate that administering statins to COVID-19 patients would reduce the risk of death, it does open the way for studies that may confirm this finding.

Rapid Changes in Inflammation Biomarker Could Be Key Predictor of COVID-19 Outcomes Researchers analyzing levels of inflammation, known to be associated with severity of illness, by looking at C-reactive protein (CRP) trends in COVID-19 patients COVID-19 patients at the Brigham and Women’s Hospital (Boston, MA, USA; www. brighamandwomens.org) found that a rapid rise in CRP levels during the first 48-to-72 hours of hospitalization was predictive of subsequent respiratory deterioration and intubation, while steadier CRP levels were observed in patients whose condition remained stable. The results from a study population of 100 COVID-19 patients also provided insight into the underlying mechanisms at play in COVID-19 infections.

AI System Distinguishes COVID-19 from Flu and Other Respiratory Diseases A new artificial intelligence (AI) system developed by scientists at Tsinghua University (Beijing, China; www.tsinghua.edu.cn)

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ISSN 0898-7270

Vol.39 No.1 • Published, under license, by Globetech Media LLC Copyright © 2020. All rights reserved. Rep­ro­duction in any form is forbidden without express permission.

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HospiMedica International February-March/2021

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COVID-19 Update Cont’d from page 4

can help doctors distinguish COVID-19 from flu and other respiratory diseases in less than three seconds. The AI system identifies the differences in CT scans of patients to accurately distinguish between these illnesses. Amidst the approaching influenza season and the growing threat of a second wave of COVID-19 infections across the world, the AI system will allow healthcare workers to distinguish between the two respiratory illnesses having similar symptoms.

Regeneron’s REGEN-COV2 Becomes First Antibody Cocktail for COVID-19 to Receive FDA EUA Regeneron Pharmaceuticals, Inc.’s (Tarrytown, NY, USA; www. regeneron.com) antibody cocktail casirivimab and imdevimab administered together (formerly known as REGN-COV2 or REGEN-COV2), a therapy currently being investigated for use in COVID-19, has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Casirivimab and imdevimab administered together are authorized for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40 kg, who have received positive results of direct SARS-CoV-2 viral testing and are at high risk for progressing to severe COVID-19 and/or hospitalization.

Eli Lilly’s Antibody Therapy Granted FDA EUA for Treatment of COVID-19 Eli Lilly and Company’s (Indianapolis, Ind, USA; www.lilly.com) investigational neutralizing antibody bamlanivimab (LY-CoV555) 700 mg has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for the treatment of recently diagnosed COVID-19. Bamlanivimab is authorized for the treatment of mild to moderate COVID-19 in adults and pediatric patients 12 years and older with a positive COVID-19 test, who are at high risk for progressing to severe COVID-19 and/or hospitalization.

Hospitalized COVID-19 Patients Receiving Inhaled Nebulized Interferon Beta-1a Show Greater Improvement Data from a Phase 2 clinical trial of Synairgen plc’s (Southampton, UK; www.synairgen.com) inhaled formulation of interferon beta-1a has shown positive results in hospitalized COVID-19 patients. The trial randomized 101 hospitalized COVID-19 patients to either SNG001, Synairgen’s inhaled formulation of interferon beta-1a, or placebo. SNG001 was shown to be well tolerated and patients who received the drug had greater odds of improvement and recovered more rapidly.

Teleradiologists Highly Accurate at Diagnosing COVID-19 on Chest CTs A new study by a group of French radiologists has found that teleradiologists can be highly accurate in diagnosing COVID-19 from chest computed tomography (CT) scans and their performance can be on par with senior radiologists. The researchers found that the results illustrated the high diagnostic accuracy in diagnosing COVID-19 of teleradiologists with various degrees of experience, in settings with different levels of prevalence, as well as excellent inter-observer agreement for chest CT. Arthritis Drug Tocilizumab Found Effective in Treating Sickest COVID-19 Patients Critically ill COVID-19 patients treated with the arthritis drug tocilizumab are significantly more likely to have improved outcomes, according to the REMAP-CAP trial, led by the Imperial College London (London, UK; www.imperial.ac.uk) and the Intensive Care National Audit & Research Centre (ICNARC) in the UK and Utrecht University (Utrecht, the Netherlands; www.uu.nl). The results show that treatment with tocilizumab, an immunosuppressive drug used to treat rheumatoid arthritis, reached a key efficacy endpoint among critically ill patients with severe COVID-19, compared to patients who did not receive

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Korean Firm Celltrion’s Anti-COVID-19 Monoclonal Antibody Treatment Kills SARS-CoV-2 Celltrion Group’s (Incheon, Korea; www.celltrionhealthcare.com) COVID-19 monoclonal antibody treatment candidate demonstrated promising safety, tolerability, antiviral effect, and efficacy in patients with mild symptoms of COVID-19 in Phase 1 clinical trial. The results indicate that the patient population treated with CT-P59, Celltrion’s anti-COVID-19 monoclonal antibody treatment candidate, experienced about 44% reduced mean clinical recovery time in comparison to the average placebo recovery time. None of the patients treated with CT-P59 required hospitalization or antiviral therapy as a result of COVID-19.

Web-Based Algorithms Applied to Low-Dose CTs Could Automate Detection of COVID-19 The Technical University of Munich (TUM Munich, Germany; www.tum.de) is starting a new research project that will focus on using computer tomography (CT) and machine learning to classify the COVID-19 pulmonary disease which is a novel viral pulmonary inflammation. The aim of the project is to apply machine learning methods to low-dose CTs of COVID-19 patients in order to perform individual, automated detection, quantification and risk evaluation of the disease.

Overuse of CT on COVID-19 Patients Raises Concerns A new study by the International Atomic Energy Agency (IAEA Vienna, Austria; www.iaea.org) has found lack of guidance on specific Computed Tomography (CT) protocols for imaging patients with COVID-19 pneumonia. The study revealed that CT was most often used to assess disease severity and less commonly for assessing suspected COVID-19 pneumonia and in outpatient settings. Conversely, the study identified several areas of concern, including those stemming from frequent report on the use of CT for initial diagnosis of suspected COVID-19 pneumonia.

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PRODUCT NEWS

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The VentMeter gas flow analyzer ensures safety and reliability of ventilators with traceable standard calibration (RCB) and simple operation and handling. It features the PulmoTrend software to maintain performance record.

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COVID-19 Update Cont’d from page 5

any immune modulation treatment. Patients receiving tocilizumab were more likely to improve (measured by a combination of organ support, such as a breathing machine, in the ICU and surviving the hospital admission) compared to patients who received no immune modulator.

Antibody Cocktails at Low Doses Could be More Effective At Treating COVID-19 Pairs of antibodies may be more effective than single antibodies at preventing and treating COVID-19, according to a new study by researchers at the University of North Carolina at Chapel Hill (Chapel Hill, NC, USA; www.unc.edu) and The Rockefeller University (New York, NY, USA; www.rockefeller.edu). The researchers have also suggested that in addition to blocking SARS-CoV-2’s entry into cells, the antibodies may combat the virus by enlisting various types of white blood cells to fight the infection.

GE Healthcare Launches First X-Ray AI Algorithm to Help Assess Endotracheal Tube Placement for COVID-19 Patients GE Healthcare (Chicago, IL, USA; www.gehealthcare.com) has launched a new artificial intelligence (AI) algorithm to help clinicians assess Endotracheal Tube (ETT) placements, a necessary and important step when ventilating critically ill COVID-19 patients. The AI solution is one of five included in GE Healthcare’s Critical Care Suite 2.02, an industry-first collection of AI algorithms embedded on a mobile X-ray device for automated measurements, case prioritization and quality control.

COVID-19 Findings Presented At RSNA 2020 Suggest AI Can Boost CT’s Performance in Predicting Disease Severity Chest computed tomography (CT) when combined with artificial intelligence (AI) can become a valuable tool for diagnosing COVID-19, according to presentations on chest imaging made at a scientific session at the RSNA 2020. In the first presentation, scientists shared results from a study conducted by Nvidia (Santa Clara, CA, USA; www.nvidia. com) that combined a deep-learning algorithm with chest CT to predict if COVID-19 patients needed to be admitted to the ICU. In another presentation, researchers from the University of Pennsylvania (Philadelphia, PA, USA; www.upenn.edu) highlighted their new approach for quantifying the percentage of lung volume involved in airspace disease on chest X-rays by using a convolutional neural network (CNN) algorithm based on 1,000 chest CT scans of COVID-19 patients.

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CPAP Treatment Delivered Early In Admission Can Save Lives of COVID-19 Patients A team of doctors at the Lancaster University (Lancashire, UK; www.lancaster.ac.uk) used Continuous Positive Airway Pressure (CPAP) machines on hospitalized COVID-19 patients to find that their lives can be saved using the medical treatment at an earlier stage.

The researchers found that the early use of CPAP potentially reduces lung damage during the worst of the COVID-19 infection and allows the patient to recover from the inflammatory effects. However, when used later, CPCP does not prevent lung damage thus leading to additional inflammation and a reduction in survival chances.

New Guidance on Managing COVID-19 Patient Airways to Help Improve Outcome of Respiratory Support and Treatment An international research group of experts led by a faculty member at the Perelman School of Medicine of the University of Pennsylvania (Philadelphia, PA, USA; www.upenn.edu) has published an international expert consensus on properly managing COVID-19 patient airways to better facilitate treatment of patients amid the pandemic.

With enough evidence from experts across the medical field, the experts were able to form a tentative consensus on the use of high-flow nasal oxygen and when tracheal intubation is best performed.

Advanced Imaging Techniques Can Help Identify and Treat Nerve Damage in COVID-19 Patients A new study by researchers from the Northwestern Medicine (Chicago, IL, USA; www.nm.org) has shown how advanced imaging technology can pinpoint what may have caused nerve damage in COVID-19 patients and help determine the best course of treatment.

After recovering from COVID-19, some patients are left with chronic, debilitating pain, numbness or weakness in their hands, feet, arms and legs due to unexplained nerve damage. In their study, the researchers have demonstrated how advanced imaging techniques can help physicians identify and treat nerve damage in COVID-19 patients.

First-Ever Oral Antiviral Drug Completely Suppresses Transmission of SARS-CoV-2 Virus within 24 Hours Researchers at the Institute for Biomedical Sciences at Georgia State University (Atlanta, GA, USA; www.gsu.edu) have found that treatment of SARS-CoV-2 infection with a new antiviral drug, MK-4482/ EIDD-2801 or Molnupiravir, completely suppresses virus transmission within 24 hours. Because the drug can be taken by mouth, treatment can be started early for a potentially three-fold benefit: inhibit patients’ progress to severe disease, shorten the infectious phase to ease the

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COVID-19 Update Cont’d from page 6

emotional and socioeconomic toll of prolonged patient isolation and rapidly silence local outbreaks.

Wearable Monitor Remotely Measures Continuous Blood Pressure and Vital Signs of COVID-19 Patients A new wearable patient monitor from Caretaker Medical (Charlottesville, VA, USA; www.caretakermedical.net) utilizes a simple finger sensor to remotely measure blood pressure and multiple vital signs, enabling touchless and clinically distanced monitoring of COVID-19 patients. The Caretaker wireless patient monitor can help clinicians safely monitor quarantine patients without ever entering the room, augment overburdened clinical resources, reduce the use of PPE, and enable safe “clinically distanced” monitoring.

Ragon Institute of MGH, MIT and Harvard (Cambridge, MA, USA; www.ragoninstitute. org) has shown that by measuring the neutralization potency of antibodies which develop in COVID-19 patients, it may be possible to identify those at a risk of severe disease or death and use that to guide treatment options. The scientists have shown that the potency of neutralizing antibodies which developed in COVID-19 patients was significantly reduced in those with severe or fatal disease compared to patients with milder infections.

Hyperpolarized Xenon MRI Can Detect Previously Unseen Lung Damage in COVID-19 Patients Research by the University of Sheffield (Sheffield UK; www.sheffield.ac.uk), in collaboration with the University of Oxford

CorVent Medical’s RESPOND-19 Ventilator Receives FDA EUA for Multiple Patient Use

(Oxford, UK; www.ox.ac.uk), is the first in Europe to use hyperpolarized xenon gas with MRI scanning to identify the impact on lung function as patients recover from COVID-19, when standard MR and CT scans may be normal. The hyperpolarized xenon MRI technique identified weakened lung function in all patients who took part in the study - this damage to lungs from COVID-19 was not visible on a standard MRI or CT scan.

New Non-Invasive Ventilation to Help Prevent Strain on Hospitals during COVID-19 Surge A non-invasive respiratory support package comprising of two devices to treat COVID-19 significantly minimizes aerosolized spread in hospitals and aims to free-up

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CorVent Medical (New York, NY, USA; www.corventmedical.com) has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for primary critical care use of the company’s RESPOND-19 Ventilator. Establishing a new category of ventilators, RESPOND-19 is designed for rapid expansion of critical care ventilation capacity to allow hospitals to treat more patients suffering from acute respiratory distress syndrome (ARDS) during times of greatest need.

COVID-19 has transformed the market and RESPOND-19 aims to address the immediate and growing need for flexible, critical care ventilator capacity.

Rapid Test Could Identify COVID-19 Patients Responding To Drug Treatment A new study by researchers at the Rabin Medical Center (Petah Tikva, Israel; www.hospitals.clalit.co.il) shows that a first-of-its-kind rapid test could identify which COVID-19 patients are responding to drug treatments and which patients are still deteriorating and need higher doses of medication.

The researchers demonstrated that a15-minute blood test from MeMed Diagnostics (Haifa, Israel; www.memed.com) for the protein interferon gamma induced protein 10 (IP-10) could help guide treatment with corticosteroids.

Measuring Potency of Neutralizing Antibodies in COVID-19 Patients Could Predict Severe or Fatal Outcomes A new study by scientists at the

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The i-view single use, fully disposable video laryngoscope reduces the risk of cross infection and incorporates a Macintosh blade which allows it to also be used for direct laryngoscopy.

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COVID-19 Update Cont’d from page 7

critical Intensive Care Unit (ICU) resources for those with more severe symptoms. Both the devices from Subsalve USA (North Kingstown, RI, USA; www.subsalve.com) and Nanotronics Health (New York, NY, USA; www.nanotronicshealth.com) have been granted Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to treat COVID-19.

UV Disinfection Robot Neutralizes Coronavirus and Protects Patients and Healthcare Workers from COVID-19 UV disinfection robots from Surfacide (Waukesha, WI, USA; www. surfacide.com) are being increasingly deployed across hospitals around the world to combat the novel coronavirus and further protect patients and healthcare workers from COVID-19. UV disinfection company Surfacide’s Helios System of UV robots are designed to help protect and keep patients and healthcare workers safe. Surfacide’s UV-C technology is scientifically proven to inactivate coronavirus - the family of viruses that make up SARS-CoV-2 and COVID-19.

Biomarker Detection Platform Configured With MRI System Can Rapidly Screen 100,000 Samples per Day for SARS-CoV-2 Menon Biosensors, Inc. (San Diego, CA, USA; www.menonbio sensors.com) has developed a breakthrough biomarker detection technology that can rapidly detect the SARS-CoV-2 virus using standard MRI systems available in hospitals. The advanced system and method, known as Molecular Mirror, is a detection technique that produces 100% accurate results within 30 minutes of bacterial and viral pathogens tests that at scale could be capable of testing upwards of 100,000 patients per day.

New Long-Acting Antibody Combination Treatment Could Give COVID-19 Immunity Researchers have begun two clinical trials for testing a long-acting antibody combination treatment to protect against COVID-19. In the STORM CHASER study, researchers from the University College London Hospitals NHS Foundation Trust (UCLH; London, UK; www. uclh.nhs.uk) have recruited 10 participants to date. They believe the antibody or LAAB, known as AZD7442 and developed by AstraZeneca(Cambridge, UK; www.astrazeneca.com) may offer immediate and long-term protection to people who have been recently exposed to the SARS-CoV-2 virus, to prevent them developing COVID-19.The

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other study, PROVENT, is looking at use of AZD7442 in people who may not respond to vaccination (for instance where someone has a compromised immune system) or are at increased risk of COVID-19 infection due to factors such as age and existing conditions.

New Virtual Screening Strategy Identifies Chemotherapy Medication That Could Be Repurposed to Treat COVID-19 Researchers at the Shenzhen Institutes of Advanced Technology (Shenzhen, China; www.siat.cas.cn) have combined a novel computational drug screening strategy with lab experiments to suggest that pralatrexate, a chemotherapy medication originally developed to treat lymphoma, could potentially be repurposed to treat COVID-19. By combining multiple computational techniques that simulate drug-virus interactions from different, complimentary perspectives, the researchers identified four promising drugs, which were then tested against SARS-CoV-2 in lab experiments. Two of the drugs, pralatrexate and azithromycin, successfully inhibited replication of the virus. Further lab experiments showed that pralatrexate more strongly inhibited viral replication than did remdesivir, a drug that is currently used to treat some COVID-19 patients.

Newly Discovered Anti-COVID-19 Nanobodies Can be Inhaled to Coat Lungs and Airways for Preventing Infections Researchers from the National Institutes of Health (NIH Bethesda, MA, USA; www.nih.gov) have isolated promising mini antibodies against COVID-19 from a llama that can be aerosolized and inhaled to coat the lungs and airways for preventing and diagnosing infections.

The team isolated a set of promising, tiny antibodies, or “nanobodies,” against SARS-CoV-2 that were produced by a llama named Cormac.

Preliminary results suggest that at least one of these nanobodies, called NIH-CoVnb-112, could prevent infections and detect virus particles by grabbing hold of SARS-CoV-2 spike proteins. In addition, the nanobody appeared to work equally well in either liquid or aerosol form, suggesting it could remain effective after inhalation.

COVID-19 Study Shows Umbilical-Cord Derived Mesenchymal Stem Cells Reduce Risk of Death and Quicken Time to Recovery A unique and groundbreaking randomized controlled trial by researchers from the University of Miami (Coral Gables, FL, USA; www. welcome.miami.edu) has shown that umbilical cord derived mesenchymal stem cell infusions safely reduce risk of death and quicken time to recovery for the severest COVID-19 patients. The researchers believe that treating COVID-19 with mesenchymal stem cells makes sense and their findings have implications for studies in other diseases as well. The next step is to study use of the stem cells in COVID-19 patients who have not yet become severely ill but are at risk of having to be intubated,

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COVID-19 Update Cont’d from page 8

to determine if the infusions prevent disease progression.

Online Risk-Stratification Tool Predicts Deterioration among Hospitalized COVID-19 Patients Researchers from the UK Coronavirus Clinical Characterization Consortium (ISARIC4C; London; UK; www.isaric4c.net) have developed a new risk-stratification tool which can accurately predict the likelihood of deterioration in adults hospitalized with COVID-19. The online tool could support clinicians’ decision making - helping to improve patient outcomes and ultimately save lives.

FDA-Approved Patient Isolation Solution Enables Hospitals to Quickly Set Up Emergency Isolation Rooms for COVID-19 Patients A revolutionary solution for patient isolation from JUD care (Shenzhen, China; www. clearofchina.com) that enables hospitals to quickly set up emergency isolation rooms has obtained approval from the US Food and Drug Administration (FDA) and could help battle the COVID-19 pandemic. sROOM, a portable negative pressure isolation room, is specially designed to quickly isolate patients while ensure public safety and a great user experience during a large-scale airborne infectious disease outbreak, such as COVID-19.

Machine Learning Tool Gives Early Warning of Cardiac Issues or Blood Clots in COVID Patients A team of biomedical engineers and heart specialists at the Johns Hopkins University (JHU; Baltimore, MD, USA; www.jhu.edu) have developed an algorithm that warns doctors several hours before hospitalized COVID-19 patients experience cardiac arrest or blood clots. The COVID-HEART predictor developed using data from patients treated for COVID-19 can forecast cardiac arrest in COVID-19 patients with a median early warning time of 18 hours and predict blood clots three days in advance.

Umbilical-Cord Derived Mesenchymal Stem-Cell Infusions Save Sickest COVID-19 Patients A unique and groundbreaking randomized controlled trial by researchers at the University of Miami Miller School of Medicine (Miami, FL, USA; www.med.miami.edu) has shown that umbilical-cord derived mesenchymal stem cell infusions safely reduce risk of death and quicken time to recovery for the severest COVID-19 patients. The researchers believe that treating COVID-19 with mesenchymal stem cells makes sense as they not only help correct immune and inflammatory responses that go awry, but also have antimicrobial activity and have been shown to promote tissue regeneration. When given intravenously, mesenchymal stem cells migrate naturally to

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the lungs. That’s where therapy is needed in COVID-19 patients with acute respiratory distress syndrome, a dangerous complication associated with severe inflammation and fluid buildup in the lungs.

Innovative Combination of Upper-Room GUV Lights and HEPA Filtration Offers Cost-Effective COVID-19 Control Solution for Hospitals An innovative combination of HEPA filtration-based air purifiers and upper-room germicidal ultraviolet (GUV) lights provided

by AeroMed Technologies (Utica, NY, USA; www.aeromed.com) is helping to protect patients and hospital personnel from COVID-19.

Upper-room GUV units are designed to irradiate air that may be potentially contaminated with bacteria, viruses or mold. Upper-room GUV lights have become a crucial, cost-effective product in the fight against COVID-19.

Rapid Blood Test Identifies COVID-19 Patients that Need ICU Care and Intubation A relatively simple and rapid blood test developed by scientists at Washington University (St. Louis, MO, USA; www. medicine.wustl.edu) can predict - within a day of a hospital admission - which patients with COVID-19 are at highest risk of severe complications or death. Their study suggests that measuring mitochondrial DNA in the blood of patients with COVID-19 can help predict which patients are at highest risk of severe disease, requiring more intensive care.

New AI Research to Help Predict COVID-19 Resource Needs from Series of X-Rays Facebook AI (Menlo Park, CA, USA; www. ai.facebook.com), in collaboration with NYU Langone Health’s Predictive Analytics Unit and Department of Radiology (Brooklyn, NY, USA; www.med.nyu.edu) has developed machine learning (ML) models that could help doctors predict how a COVID-19 patient’s condition may develop, in order to help hospitals ensure they have sufficient resources to care for patients. The scientists have developed three ML models that can help hospitals know whether COVID-19 patients are likely to need escalated treatment and plan accordingly.

Encouraging Results on Ivermectin for Reducing Viral Transmission in Mild COVID-19 Patients A small pilot study led by the University of Navarra Clinic (Pamplona, Spain; www.unav. edu) and the Barcelona Institute for Global Health (ISGlobal; Barcelona, Spain; www. isglobal.org) suggests that early administration of ivermectin can reduce viral loads and symptom duration in patients with mild COVID-19, which in turn could help reduce viral transmission. Ivermectin is an antiparasitic drug that has been shown to reduce SARS-CoV-2

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COVID-19 Update Cont’d from page 9

replication in vitro (in cell lines), albeit at concentrations that exceed those recommended for human use. The new study warrants further exploration in larger clinical trials.

Innovative Negative Pressure Ventilator Could Provide Additional Treatment Options for COVID-19 Patients with Respiratory Failure A new negative pressure ventilator created by Exovent (London, UK; www.exovent.info) could provide additional treatment options for patients with respiratory failure, including those with COVID-19.

The negative pressure ventilator designed to assist the recovery of COVID-19 patients and for the treatment of pneumonia and COPD has been unveiled by Exovent, a UK task force comprising of anesthetists, nurses and engineers for rapid innovation to combat the unique challenge presented by this highly contagious and aggressive disease.

Respiratory Device Using Low-Flow Extracorporeal Carbon Dioxide Removal Technology Aids Recovery in COVID-19 Patients with Pneumonia The Hemolung Respiratory Assist System (RAS), a low-flow extracorporeal carbon dioxide removal (ECCO₂R) respiratory device from ALung Technologies, Inc. (Pittsburgh, PA, USA; www.alung.com), is helping treat COVID-19 patients with acute respiratory failure The Hemolung RAS is the only ECCO₂R device currently granted an Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) for the treatment of COVID-19. ECCO₂R therapy with the Hemolung RAS allows carbon dioxide to be removed from the blood independently of the lungs with the aim of facilitating the avoidance or reduction of intubation and invasive mechanical ventilation.

ECMO/CRRT Combined Support an Important Technique Treatment for Critically Ill COVID-19 Pneumonia Patients A new study by researchers at the Fudan University (Shanghai, China; www.fudan.edu.cn) has found that extracorporeal membrane oxygenation (ECMO) combined with continuous renal replacement therapy (CRRT) is an important treatment technique for the treatment of critically ill COVID-19 patients with SARS-CoV-2 pneumonia. The researchers have concluded that the survival rate of patients with cardiopulmonary failure treated with ECMO/CRRT in whom conventional treatment failed in this group was 100%, which indicates that combined treatment

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with ECMO and CRRT is an important treatment technique for the treatment of critically ill COVID-19 patients with SARS-CoV-2 pneumonia.

NSAIDs Might Exacerbate or Suppress COVID-19 Depending on Timing, Study Suggests New research by Yale University School of Medicine (New Haven, CT, USA; www.medicine.yale.edu) has shown that non-steroidal anti-inflammatory drugs (NSAIDs) reduced both antibody and inflammatory responses to SARS-CoV-2 infection in mice. The research has revealed that NSAIDs taken during COVID-19 could be harmful or beneficial, depending upon the timing of administration.

MRI-Based Technology Maps Effects of COVID-19 on Body’s Key Organs The UK’s Medicines & Healthcare products Regulatory Agency (MHRA) has approved the use of CoverScan MD, an MRI-based technology developed by Perspectum Group (Oxford, UK; www.coverscan. com) that maps the effects of COVID-19 on several of the body’s key organs. With 1 in 20 COVID-19 patients predicted to experience ongoing symptoms, or “Long COVID”, CoverScan MD quickly and safely provides medical professionals with the information critically needed to assess and evaluate patients.

Functional MRI Can Provide Clearer Picture of Unresponsive COVID-19 Patient’s Brain Function and Potential for Recovery A new study led by a team at Massachusetts General Hospital (Boston, MA, USA; www.massgeneral.org) has provided proof of principle that clinicians may be able to use advanced imaging techniques like functional MRI to get a clearer picture of the brain function of unresponsive COVID-19 patients and their potential for recovery. In the study, a patient with severe COVID-19 who, despite prolonged unresponsiveness and structural brain abnormalities, demonstrated functionally intact brain connections and weeks later recovered the ability to follow commands.

AI-Based Multi-Modal COVID-19 Risk Score Improves Severity Prediction of Hospitalized COVID-19 Patients The AI-Severity Score, a machine learning model developed by Owkin (New York, NY, USA; www.owkin.com), trained on multimodal data sets that include CT scans of the lungs, and is plug and play, can predict the severity of a COVID-19 patient’s disease prognosis with a performance that surpasses all other currently published score benchmarks. The AI-Severity Score has been developed to help identify hospitalized COVID-19 patients at risk for severe deterioration.

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Lung Ultrasound Can Predict Clinical Progression of Severe COVID-19 Patients, Finds Study

L

ung 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 reported by Agência

FAPESP. Given the importance of diagnostic imaging of the lungs to the treatment of severe COVID-19 patients, researchers at the University of São Paulo’s Medical School (FM-USP; São Paulo City, Brazil) assumed it could also be useful to screen patients admitted with the infection based on predicted outcome. They chose lung ultrasound to test the hypothesis because the method is widely used in ERs, as well as being fast, easy to perform with portable equipment, and inexpensive. In the study, the team applied an ultrasound examination protocol covering 12 lung regions in 180 COVID-19 patients undergoing treatment at the hospital.

The study subjects were patients diagnosed by RT-PCR and admitted to the hospital between March and May 2020, in the initial stages of the pandemic. The researchers performed lung ultrasound exams on the volunteers and calculated their scores on the day of admission to the ER. The median age of the subjects was 60, and well over half (58%) were male. The scoring methodology, known as the LUS protocol, entailed examining 12 lung regions in the anterior, lateral, and posterior aspects of the chest wall on both sides.

Each region was evaluated by aeration pattern, with scores ranging from zero to 3 points according to the worst pattern observed. The final score was the sum of points in all 12 regions, ranging from zero to 36.

The results showed that the higher the lung ultrasound score, the greater the risk of admission to an intensive care unit (ICU), intubation, and death.

Patients scoring 14-16 were most likely to require ICU care, and a fatal outcome was most likely for those with scores above 20. The average LUS was 18.7, with a standard deviation of 6.8. Of the 180 patients enrolled, 109 (60%) were discharged alive, 74 (56%) were treated in the ICU, 52 (39%) were intubated and 61 (33%) died.

“We found lung ultrasound to be a good predictor of the need for intensive care with endotracheal intubation and the risk of death for COVID-19 patients admitted to the emergency room. It can be a simple, cheap way to estimate the prognosis for patients infected by the virus,” Heraldo Possolo de Souza, principal investigator for the study, told Agência FAPESP. “Point-of-care lung ultrasound is extremely important in the pandemic. It can be performed at the bedside by ER staff who don’t need to be as highly trained to interpret the images as they do in the case of a chest CT scan, for example,” said Julio Cesar Garcia de Alencar, the first author of the article on the study.

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Features include five transducer connectors for fast probe switching to adapt to demanding clinical environments; fast boot time and smart stand-by function; one touch image optimization through intelligent real-time algorithms; and two exclusive solutions, easyMode and easyColor, which simplify the number of parameters to be adjusted by the users and drive ultrasound image optimization in just three swipes. Options include Virtual Navigator for fusion imaging, QElaXto shearwave elastography, and automation tools such as eScan and eDoppler.

“The MyLab X8 Ultrasound System is uniquely suited for the demands of a myriad of applications, whether in the hospital or in the office,” said Robert Lewis, President and General Manager at Esaote North America. “Esaote has a legacy of producing high quality imaging solutions that are accessible and incorporate advanced technologies. We are committed to developing fully featured and versatile imaging systems with unmatched efficiency and scalability.”

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The Sonosite PX ultrasound system offers advanced image clarity for high confidence when treating and diagnosing patients. The new interface combines touch and physical controls for improved efficiency.

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3D Ultrasound Upgrades AAA Surveillance Options

novel ultrasound abdominal aortic aneurysm (AAA) model provides diagnostic confidence without exposing patients to high doses of radiation and nephrotoxic contrast agents.

The Royal Philips (Amsterdam, The Netherlands; www.philips. com) Philips AAA Model integrates 3D ultrasound technologies and innovative software into a single solution that automatically segments and quantifies the size of the aneurysm sac to improve surveillance of known untreated (native) AAAs, as well as those that have undergone endovascular aneurysm repair (EVAR). The model provides several key measurements, including the maximum anterior-to-posterior (AP) diameter, partial volume of the AAA, and centerline.

The maximal diameter of an AAA is ideally measured perpendicular to the centerline; Philips AAA Model provides it throughout the volume of the 3D acquisition. And knowing the partial volume is beneficial, as it has been observed that more than one-third of small AAAs considered to be stable based on diameter alone were actually growing in volume. According to Philips, this suggests that measuring partial volume has the potential to supplant diameter as the most important single parameter in the diagnosis and surveillance of AAAs. “Regular surveillance of abdominal aortic aneurysm patients is essential, but today’s standard of care has downsides,” said Bich Le, general manager of Ultrasound at Royal Philips. “The Philips Abdominal Aortic Aneurysm Model seamlessly integrates leading Philips technologies, including Philips Premium Ultrasound System (EPIQ Elite),

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Philips Array Transducer (X6-1 xMATRIX), and innovative software into a single solution, to help improve the experience and outcomes for clinicians and patients alike.”

Typically, AAAs are identified incidentally during abdominal imaging exams but, in some cases, remain undetected until rupture. A ruptured AAA has an 80% mortality rate, emphasizing the importance of routine surveillance. The current standard of care for AAAs includes computed tomography angiography (CTA) and standard ultrasound scans.

Image: A new ultrasound model helps monitor AAA progression (Photo courtesy of Philips)

Digital Wrist Tomosynthesis Assesses Women’s Bone Health

new study shows how digital breast tomosynthesis (DBT) scanners can also be used to perform bone density measurements.

Researchers at Henry Ford Health System (Detroit, MI, USA; www.henryford.com) conducted a study to explore the feasibility of using DBT devices for digital wrist tomosynthesis (DWT) so as to measure bone mineral density (BMD), cortical bone thickness, and microstructural properties of the wrist bone. The results were then correlated to reference measurements acquired via microcomputed tomography and dual energy x-ray absorptiometry (DXA). The researchers recruited five patients, (19 to 75 years of age), who aligned their left hand on a generic hand template taped to a DBT machine.

The results showed that measurements from DWT imaging

with a DBT scanner were highly repeatable; in ex-vivo trials, DWT derived BMDs were strongly correlated with reference measurements, as was the cortical thickness measured at lateral and medial cortices, and the majority of microstructural measures. In-vivo

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Medical Imaging

Optoacoustic Technology Enhances Breast Cancer Diagnostics

or Cont’d from cover other imaging examinations such as screening mammography.

Imagio uses laser optics and grayscale ultrasound to provide fused, functional, and anatomical breast imaging.

The OA images provide a unique blood map in and around breast masses, while US provides a traditional anatomical image. Through the appearance (or absence) of two hallmark cancer indicators, angiogenesis and deoxygenation, radiologists can confirm or rule out malignancy, without necessitating the use of ionizing radiation (x-rays) or contrast agents. In addition to imaging enhancement, Imagio also includes SenoGram, an artificial intelligence (AI) physician decision support tool that aids in the interpretation of the new images.

“Optimizing the diagnosis of breast masses requires a combination of very high sensitivity, over 98%, while simultaneously maximizing specificity and minimizing false positives and biopsies of benign masses,” said A. Thomas Stavros, MD, chief medical officer of Seno.

“Other modalities have reported improvements in specificity, but these have often come at the expense of the desired high sensitivity.”

Optoacoustic imaging is an imaging modality that uses nonionizing laser pulsing of biological tissues to initiate a photoacoustic

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DCR Identifies Pleural Invasion of Lung Tumors

of lung tumors with DCR, using a four-dimensional (4D) extended cardiac-torso (XCAT) computational phantom with simulated respiratory and cardiac motions; to simulate lung tumors, a 30-mm diameter sphere was inserted into each lobe of the phantom.

The virtual patient during respiration was virtually projected using an X-ray simulator in posteroanterior (PA) and oblique directions, and sequential bone suppression (BS) images were created. Measurement points (tumor, rib, and diaphragm) were automatically tracked on the simulated images by a template matching technique.

The researchers then calculated five quantitative metrics related to the movement distance and directions of the targeted tumor, and evaluated whether DCR could distinguish between tumors with and without pleural invasion/adhesion.

The results showed precise tracking of the targeted tumor, without undue influence of rib shadows. There was a significant difference in all five quantitative metrics between the lung tumors with and without pleural invasion. Metrics related to movement distance were effective for tumors in the middle and lower lobes, while those related to movement directions were effective for tumors close to the frontal chest wall on the oblique projection view. The oblique views were useful for the evaluation of the space between the chest wall and a moving tumor. The study was published on February 3, 2021, in Medical Physics.

“Imaging modalities like cine MRI or breathing chest CT can be used to assess tumor invasion and adhesion, but both are more costly than x-ray; MRI often isn’t available, while CT carries a higher radiation burden than radiography,” said lead author Rie Tanaka, PhD, of Kanazawa University. “With DCR, a series of sequential chest radiographs are obtained of a standing patient through a 10-second respiratory cycle. Except for the breathing pattern, images are acquired in the same manner as a conventional radiograph.”

Preoperative assessment of tumor invasion and adhesion is

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effect, in which part of the energy is absorbed and converted into heat, leading to a transient thermoelastic expansion, which generates a wideband ultrasonic emission. As the optical absorption is closely associated with physiological properties–such as hemoglobin concentration and oxygen saturation–the photoacoustic signal, detected by ultrasonic transducers, is proportional to local energy deposition.

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imperative when planning surgical excision of lung tumors. If the tumor moves independent of parietal or mediastinal pleura, it means that it is not invasive or strongly adheres to lung tissue, and therefore may be easier to remove surgically.

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Multi-Parametric Prostate MRI Underestimates Tumors

new study suggests that multi-parametric MRI (mpMRI) routinely measures radiologic tumor size (RTS) as smaller than actual pathologic tumor size (PTS).

Researchers at the David Geffen School of Medicine (Los Angeles, CA, USA; https://medschool.ucla.edu) conducted a study involving in 441 consecutive patients with 461 prostate cancer lesions who were scheduled for radical prostatectomy. The aim of the study was to evaluate agreement between RTS (defined as maximum tumor diameter on mpMRI), and whole mount histopathology PTS. The disparity in size was assessed, and clinical, pathological, and radiographic predictors of pathological tumor size were examined.

The results showed that mean RTS (1.57cm) regularly underestimated mean PTS (2.37 cm), regardless of preoperative covariates, and the degree of underestimation increased with smaller RTS and lower PI-RADSv2 scores. PTS was also significantly larger for biopsy Gleason GG5 compared to GG1; PI-RADSv2 5 lesions compared to PI-RADSv2 4 lesions; and higher prostate specific antigen (PSA) density. The study was published in the February 2021 issue of Journal of Urology.

“Our study suggests that by relying on RTS alone we can only be sure of complete ablation of the mpMRI detected lesion if a large margin is used in the largest diameter, especially for tumors less than two cm,” concluded lead author Aydin Pooli, MD, and colleagues. “Smaller margins, although acceptable, will have a lower degree of certainty for complete ablation of the prostate lesion.

Incorporating tracked biopsy around the mpMRI detected prostate

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lesion could help overcome the tumor characterization limitations.”

Multiparametric MRI refers to the multiple sequences required to make the diagnosis, consisting of both anatomic T1-weighted and T2-weighted MRI sequences, and functional sequences, such as diffusion-weighted imaging MRI and dynamic contrast-enhanced MRI. By combining different types of scans, a clearer picture of the scanned area becomes available. Injecting a contrast agent also helps to enhance the image.

Image: mpMRI imaging measures prostate tumor size as smaller than true (Photo courtesy of Alamy)

Digital Wrist Tomosynthesis Assesses Women’s Bone Health

measurements were quick and tolerated well by the volunteer patients with no discomfort, and appeared to be different between young and old participants in a preliminary comparison. The study was published on December 13, 2021, in Bone.

“DWT is feasible in a mammography setting, and informative on bone mass, cortical thickness, and microstructural qualities that are known to deteriorate in osteoporosis. To our knowledge, this study represents the first application of DBT for imaging bone,” concluded lead author Yener Yeni, PhD, and colleagues. “It is reasonable to

expect that with increasing adoption of DBT and continued high adherence to breast screening, bone screening would become more prevalent if offered in coordination with DBT breast exams.”

Osteoporosis is defined as a bone density of 2.5 standard deviations below that of a young adult, as measured by DXA. It is the most common reason for a broken bone among the elderly, and may be due to a lower than normal peak bone mass and a greater than normal bone loss. It is more common in women than men, with 2-8% of males and 9-38% of females affected after menopause, usually due to lower levels of estrogen.

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Medical Imaging

Home Reading Station Allows Radiologists to Work from Afar

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new radiology solution specifically designed for remote reading provides the same level of quality, security, and performance as a hospital workstation.

Developed jointly by Barco (Kortrijk, Belgium; www.barco. com) and VisionTek (Schaumburg, IL, USA; www.visiontek. com), the eGFX Home Read Station combines a pre-installed Barco MXRT-display controller with the VisionTek Thunderbolt 3 Mini eGFX Enclosure. The sleek, portable device sits on a desk or hidden away beneath it, discretely handling graphic intensive medical scan applications. To use, a laptop or PC are connected to the enclosure to start reading medical images and obtain access to additional features, such as Barco’s clinical tools and QAWeb. The eGFX Home Read Station provides four DisplayPort 1.4 video outputs; two USB 3.0 ports on the front for added Image: The eGFX Home Read Station connecting a laptop to connectivity; a RJ 45 Gigabit Ethernet port for high speed Barco Monitors (Photo courtesy of VisionTek) network connectivity; dual Thunderbolt 3 controllers for dedicated bandwidth; an aluminum design for lightweight performance; and a compact design and small footprint. The system is compatible with Barco display systems and validated mobile workstations from Lenovo, Dell, and HP. Using Barco QAWeb Enterprise, quality and compliance of all workstations can be managed remotely, so software updates and security scans can be executed easily.

“This configuration is seamlessly deployable and mirrors the hospital readPRINT MAGAZINE ing environment, providing the same diagnostic confidence and medical compliINTERACTIVE ance maintained within hospital walls,” DIGITAL EDITION said Mike Sklar, VP of Healthcare Sales WEB PORTAL for the Americas at Barco. “It’s paired ENGLISH • SPANISH with Barco’s QAWeb calibration and monitoring software, which is the industry’s first and only web-based service for high-grade quality assurance.”

“VisionTek’s Mini eGFX enclosure powered by Barco MXRT series graphics boards and diagnostic displays allow radiologists to remotely read scans in the safety of their home office,” said Michael Innes, president of VisionTek. “VisionTek is very proud to play a small part in technology innovation that impacts some of the most critical healthcare applications within the radiology community.”

The Covid-19 pandemic has forced MOBILE a significant portion of the workforce VERSION to work from home. Remote reading .com allows radiologists to work more efficiently, ensure optimal working conditions, and enables a flexible work schedule. On-call demand and weekend and ­­PRINT MAGAZINE • INTERACTIVE DIGITAL EDITION late-evening duties, for example, can be WEB PORTAL • MOBILE VERSION • MOBILE APPS performed at home instead of at the hosE-NEWSLETTER • E-MAIL MARKETING pital. With the millennial generation and ONLINE SOLUTIONS • SHOW DISTRIBUTION digital natives entering the workforce, home reading is becoming a standard benefit in radiology hiring.

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The SYS-50 syringe pump offers eight kinds of infusion modes and features an occlusion pre-alarm system that makes infusion safer.

Other features include a 3.5-inch touchscreen operation and syringe slider protection.

The SpiroAir volumetric P.F.T. system features a Gold Standard dry rolling seal spirometer with the most reliable and accurate transducer on the market, ideal for accurate spirometry, lung volume and diffusion measurements.

The F3 is a portable fetal monitor featuring an elegant design, bright color screen and enhanced functionality, and offers an extensive set of monitoring parameters such as FHR, TOCO, DECG, IUP and fetal movement.

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Remote Pulse Oximeter Monitors Patients at Home

fingertip pulse oximetry (SpO2) adapter expands virtual home examination and diagnosis telehealth capabilities.

The Tyto Care (Netanya, Israel, www.tytocare.com) Pulse Oximeter is a finger device that connects by cable to the TytoCare, a hand-held telehealth system that enables comprehensive physical examinations of the heart, skin, ears, throat, abdomen, as well as lungs and body temperature to be completed from afar.

TytoCare facilitates live video medical examinations; provides a cloud-based data repository with analytics; and uses built-in guidance technology and machine learning algorithms to ensure accuracy and ease of use for patients and useful insights for healthcare providers.

During the SpO2 exam, users are prompted to place their finger in the adapter for 15 seconds. Upon completion, blood oxygen and heart rate results appear immediately on the screen of the SpO2 adaptor and the TytoCare device itself, recorded for subsequent review by the clinician, and sent to the patients’ electronic health record (EHR). The clinician can see the results immediately in the TytoCare Clinician Dashboard, and can assess the reliability of the results recorded by viewing the heart rhythm graph generated during the exam.

“The COVID-19 pandemic thrust telehealth into the spotlight, and we are constantly enhancing the TytoCare platform to ensure users have access to the most comprehensive telehealth solution available,” said Dedi Gilad, CEO and Co-Founder of Tyto Care.

“The pandemic will eventually be behind us, yet telehealth will remain a key component in the future of healthcare, providing

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patients with the best possible remote care and clinicians with actionable insights into their patients’ health.”

The TytoCare device comes with a built-in exam camera and basal thermometer, together with a range of adaptors that include an otoscope for ear examinations, a stethoscope (with volume, bell, and diaphragm filters) adaptor for auscultation of the heart and lungs, a tongue depressor adaptor, and ear buds. It also includes the TytoApp for conducting live video telehealth exams, reviewing them, and communicating with physicians.

Image: The TytoCare hand-held telehealth system (Photo courtesy of Tyto Care)

Clinical Wound Dashboard Elevates Patient Care

Zoom clinical wound dashboard, a part of the WoundZoom software platform, is designed to ascertain treatment protocols by integrating advanced three dimensional (3D) imaging, content management, and analytic software. Intuitive workflows, automated image capture, and complete documentation at the point of care help eliminate errors and enables efficient case management, with clinical analytics and reporting available both offline and online for remote patient management (RPM).

The integration with WoundZoom imaging hardware delivers accurate, high-resolution non-contact 3D wound images--including length, width, depth, area and volume--with automated tissue classification and composition. Clear, consistent, and coherent reference points are marked to precise mark wound borders and measurements, including wound healing progression. A standardized

wound assessment and documentation process is provided, which includes secure electronic medical record (EMR) access for RPM through laptop, smartphone, or tablet device.

“We are proud to release this intuitive and insightful dashboard to support our customers as they care for their patients,” said Mark Lacerte, President of Perceptive Solutions. “The ability to have a snapshot of an organization’s entire wound care patient population helps administration and clinicians identify trends across the population and take appropriate actions to help deliver better wound care for their patients.”

The guiding principles of wound care are focused around defining the wound, identifying any associated factors that may influence the healing process, and selecting the suitable wound dressing or treatment device to aid the healing process.

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Mathematical Model Could Help Clinicians to Safely Allow Two COVID-19 Patients Share a Single Ventilator

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team of engineers have developed a mathematical model that could help clinicians to safely allow two COVID-19 patients to share a single ventilator.

Members of the University of Bath’s Centre for Therapeutic Innovation and Centre for Power Transmission and Motion Control (Bath, England) have published a first-of-its-kind research paper on dual-patient ventilation (DPV), following their work which began during the first wave of the SARSCoV-2 virus in March 2020. DPV presents several challenges: accurate identification of patients’ lung characteristics over time; close matching of patients suitable to be ventilated together, and the risk of lung damage if airflow is not safely maintained.

Image: Lung Ultrasound Can Predict Clinical Progression of Severe The BathRC model enables doctors to calculate the amount of COVID-19 Patients, Finds Study (Photo courtesy of Rovena Rosa/ restriction required to safely ventilate two patients using one Agência Brasil) ventilator.

As a practice, DPV is strongly advised against by healthcare bodies given the potential for lung damage, and the team NE DES W stresses that their findings should only be IGN used in extreme situations where patients outnumber available equipment. No testing has been carried out on patients, instead the research so far has taken place WORLD’S MEDICAL PRODUCT MARKETPLACE using artificial lungs, normally used to calibrate ventilators. The model equates the ventilator circuit to an electrical circuit with resistance and compliance SIGN UP considered equivalent to electrical FOR FREE! resistance and capacitance; this enabled a simple calculator to be created.

While DPV has been previously attempted during the COVID-19 pandemic, the paper is the first to provide clinicians with the calculations needed to safely ventilate two patients with one machine. The model is able to predict tidal lung volumes accurate to within 4%. In addition to further testing, some hurdles remain before clinicians could safely attempt dual-patient ventilation using the BathRC model. The team plans to publish further research soon into how to create an adjustable airflow restrictor.

“We are not advocating dual-patient ventilation, but in extreme situations in parts of the world, it may be the only option available as a last resort. The COVID-19 crisis presents a potential risk Connecting Buyers with of hospitals running short of ventilators, so it is important we explore contingencies, Suppliers Worldwide such as how to maximize capacity,” said Reach new sources of supply Professor Richie Gill, Co-Vice Chair of Identify latest products and technologies the Centre for Therapeutic Innovation Send inquiries directly to suppliers Receive latest product alerts and the project’s principal investigator.

Chat live with suppliers “This isn’t something we’d envisage being needed for critical-care patients.

However, one of the issues with COVID is that people can need ventilation for TradeMed provides a sophisticated yet easy-to-use global B2B platform for sourcing medical equipment. TradeMed connects buyers and sellers worldwide through a safe, secure and dyseveral weeks. If you could ventilate two namic network. Solely dedicated to medical products, TradeMed is the premier choice for medrecovering patients with one machine ical suppliers, hospital decisionmakers and buyers worldwide, regardless of size or budget. it could free up another for someone in critical need.”

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TRANSPORT VENTILATOR

VENTILATOR

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The Oxylog 3000 plus for transport ventilation offers high performance ventilation with features such as AutoFlow®, integrated capnography and non-invasive ventilation.

The Flow-iC20 ventilator uses technology that combines high power with high sensitivity and accuracy to gently optimize gas exchange in the lungs and minimize the risk of complications.

The V20 vital signs monitor features an intuitive and clear LCD Touch Display and can be connected to any hospital network (LAN or Wi-Fi) for convenient patient data management.

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Idiopathic Intracranial Hypertension Prevalence is Escalating

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he incidence of idiopathic intracranial hypertension (IIH) is rising considerably, corresponding to population increases in body mass index (BMI), claims a new study.

Researchers at Swansea University (United Kingdom; www.swansea. ac.uk/) conducted a retrospective cohort study of 35 million patient years of routinely collected healthcare data in order to characterize trends in incidence, prevalence, and healthcare outcomes in the IIH population of Wales between 2003 and 2017; in all there were 1,765 cases of IIH in 2017 (85% of them female). The researchers noted BMI, deprivation quintile, cerebrospinal fluid (CSF) diversion surgery, and unscheduled hospital admissions in both case and control cohorts.

The results showed that the prevalence of IIH in Wales increased sixfold between 2003 and 2017, with a concomitant threefold increase in incidence. This matched with obesity rates: while 29% of the study population was obese in 2003, 40% were so by 2017. IIH prevalence was also associated with increasing deprivation and destitution. Nine percent of IIH cases had CSF shunts placed, with less than 0.2% having bariatric surgery.

Unscheduled hospital admissions were also higher in the IIH cohort, as compared to the control cohort. The study was published on January 20, 20201, in Neurology.

“The considerable increase in IIH incidence is multifactorial, but likely predominately due to rising obesity rates. The worldwide prevalence of

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obesity nearly tripled between 1975 and 2016, and therefore these results also have global relevance,” concluded senior author William Owen Pickrell, PhD, and colleagues. “Around 85% of our IIH cohort were female, similar to other studies, and we also found a significant association with increased deprivation, particularly in women.”

IIH is a condition of unknown etiology strongly associated with obesity, predominantly affecting women of childbearing age. It causes chronic disabling headaches, visual disturbance, and in a minority of patients, permanent visual loss. The definitive management is weight loss, but a minority of patients requires placement of CSF diversion shunts to preserve vision.

CT Radiomics Helps Classify Small Lung Nodules

Early Detection of Lung Cancer (PanCan) study--to characterize, analyze, and classify small lung nodules as malignant or benign by extracting approximately 170 texture and shape radiomic features, following semiautomated nodule segmentation on the images. They then compared the performance of the algorithm with that of the Prostate, Lung, Colorectal, and Ovarian (PLCO) m2012 malignancy risk score calculator on another dataset.

The study cohort consisted of 139 malignant nodules and 472 benign nodules that were approximately matched in size. The researchers applied size restrictions (based on Lung-RADS classification criteria) to remove any nodules from the dataset that would already be considered suspicious, which would include any nodule with solid components greater than 8 mm in diameter. The results showed the ML algorithm significantly outperformed the (PLCO) m2012 risk-prediction model, especially when demographic data were added to radiomics analysis.

The study was presented at the AACR Virtual Special Conference on Artificial Intelligence, Diagnosis, and Imaging, held during January 2021.

“The best results were achieved in a subset of patients who were younger than 64, female, did not have emphysema, smoked fewer than 42 pack years, did not have a family history of lung cancer, and were not current smokers,” said senior author and study presenter Rohan Abraham, PhD. “Combined with clinician expertise and experience, this has the potential to enable earlier intervention and reduce the need for follow-up CT.” Current lung nodule classification relies on nodule size, a factor that is of limited use for sub-centimeter nodules, or on volume doubling time, a variable that requires follow-up CT exams. As a result, very small lung nodules, with solid components of less than 8 mm in diameter (and therefore below the Lung-RADS 4A risk-stratification threshold), are very difficult to classify, and they are often given a “wait and see” management plan.

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Critical Care

Surface Temperature Scanners Are Unreliable Fever Detectors

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nfrared thermographic screening for Covid-19 and other febrile infections can result in a large number of false negatives, according to a new study.

Researchers at the University of Portsmouth (United Kingdom; www.port.ac.uk) and Jozef Stefan Institute (Ljubljana, Slovenia; www. ijs.si/ijsw) conducted a review of literature regarding infrared (IR) thermometers and found that different IR thermometers give different results varying by as much as 2° C, and that more than 80% people tested using IR thermography can give a false negative result, due to a myriad of reasons, such as ambient temperature, infections, sunburn, exercise, and blood pressure. In addition, measuring skin temperature does not give an accurate estimation of deep body temperature.

The researchers suggest therefor, that as a direct measure of deep body temperature is impractical out of the hospital setting, and is also more expensive, overly invasive, and too time consuming for practical widespread use, taking two temperature measurements, one of the finger and the other of the eye, is likely to be a better and more reliable indicator of a fever-induced increase in deep body temperature. The study was published on January 21, 2021, in Experimental Physiology.

“If scanners are not giving an accurate reading, we run the risk of falsely excluding people from places they may want, or need, to go, and we also risk allowing people with the virus to spread the undetected

infection they have,” said senior author Professor Michael Tipton, PhD, of the University of Portsmouth. “The pandemic has had a devastating global effect on all aspects of our lives, and unfortunately, it’s unlikely to be the last pandemic we face. It’s critical we develop a method of gauging if an individual has a fever that’s accurate and fast.”

The most common and widespread symptom of COVID-19 is a fever, followed by loss of taste and smell and a host of other symptoms, including dry cough, sputum production, shortness of breath, muscle or joint pain, sore throat, headache chills, nausea or vomiting, nasal congestion, and diarrhea.

Robotic-Assisted Solution Simplifies TKR Procedures

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VELYS robotic-assisted solution is a table mounted system that adapts to the surgeon’s workflow and simplify knee replacement surgery by integrating with the DePuy Synthes ATTUNE Total Knee system. The instinctive, integrated design uses proprietary technology to maintain and control the saw cut plane in order to execute reproducible surgeon-controlled bone cuts. An instinctive user interface streamlines procedures via a fast registration process that improves efficiency.

A high-speed camera, triple-drive motion technology, and hydrophobic optical reflectors work together to adjust and control the resection plane for accurate, consistent execution. Pre-resection assessment of knee alignment and predicted gap balance help plan optimal ATTUNE Knee implant position and predict joint stability.

PROADJUST single-page planning software adjusts parameters to personalize alignment and balance relative to soft tissues throughout the full range of motion, prior to execution of bony cuts. Finally, post-resection assessment helps verify final gap balance and overall leg alignment for an intra-operative confirmation of implant position.

“Coupled with the ATTUNE Total Knee, the VELYS roboticassisted solution is highly differentiated, and can help improve clinical outcomes and increase patient satisfaction, providing a more attractive clinical solution to current options on the market,” said Aldo Denti, company group chairman of DePuy Synthes. “With the addition of the VELYS robotic assisted solution to our VELYS Digital Surgery Platform, we are continuing our vision to be the most personalized and connected orthopaedics company.”

“I’ve used the VELYS robotic-assisted solution in several of my ATTUNE Knee procedures and have found it to be accurate, fast and efficient. I’ve found my knees to be well balanced at the end of the procedure and my patients are doing well post-operatively,” said orthopedic surgeon Mark Clatworthy, MD, of Mercy Ascot Hospital (Auckland, New Zealand). “The device enables me to evaluate the bony anatomy and soft tissue envelope of the knee to plan the optimal implant position, and then use the robotic-assisted solution to deliver and execute the plan.”

During TKR, arthritic bone and cartilage are removed from the knee and replaced with anatomically shaped metal and plastic components impacted onto the bone or fixed using polymethylmethacrylate

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(PMMA) cement. The surgery involves detachment of part of the quadriceps muscle from the patella, which is displaced to one side to allow exposure of the distal end of the femur and the proximal end of the tibia.

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SURGICAL SMOKE EVACUATOR BUFFALO FILTER

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The ViroVac surgical smoke evacuator features a customizable (variable) filter life, compact shelf design and three-port filter with filter life tracking technology. Compact design allows for easy placement on shelf or counter.

The TruSystem 7500 SensorLine surgical table offers intelligent functionality for increased safety and flexibility. Features include overload protection, collision monitoring, extended X-ray range, iso-centric tilt, and more.

Feather Disposable Microtome Knives consist of special disposable blades and holder, with state-ofthe-art Feather sharpening technology giving blades unsurpassed cutting performance.

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New Angioplasty System Alleviates Peripheral Artery Disease

novel sirolimus-eluting balloon (SEB) treats long tibial occlusive lesions in peripheral artery disease (PAD) patients with critical limb ischemia (CLI).

The MedAlliance (Nyon, Switzerland; www.medalliance.com) Selution sustained limus release (SLR) balloon technology is based on unique micro-reservoirs made from a biodegradable polymer intermixed with the anti-restenotic drug Sirolimus. The manufacturing process for the SEB micro-reservoirs results in millions of miniature, precisely formed, drug delivery pods, of uniform size and with the same drug elution properties.

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ogy (CAT) process.

This mixes the micro-reservoirs with amphiphatic lipids--containing both positive and negative ions--that envelop them to ensure they remain on the SBE during its insertion into the artery and delivery to the lesion.

Once expanded, the amphiphatic lipid carrier is attracted to negatively charged membranes in the endothelial cells, resulting in adhesion of the micro- reservoir coating, and subsequently providing the controlled, sustained release of the drug. After more than 90 days, the micro-reservoirs are fully biodegraded, and the vessel is returned to its natural state, with nothing left behind.

“Selution SLR is designed to deliver the same safety and performance as best-in-class

drug eluting stent technology, with the added benefit of leaving nothing behind,” said Jeffrey Jump, chairman and CEO of MedAlliance.

“Our breakthrough technology has shown to be effective and safe in below the knee diseases in highly complex patients.”

Sirolimus is a macrolide rapamycin (mTOR) macrocyclic lactone inhibitor used to coat coronary stents, prevent organ transplant rejection, and treat a rare lung disease called lymphangioleiomyomatosis. It is naturally produced by the bacterium Streptomyces hygroscopicus and was isolated for the first time in 1972 by Surendra Nath Sehgal from samples found on Easter Island, which led to its original name, rapamycin after the native name of the island, Rapa Nui.

Medical Tablet Monitors Patients During Emergencies

n end-to-end tablet helps clinicians remotely monitor larger patient populations during emergency situations, such as the COVID-19 pandemic.

The Royal Philips (Philips; Amsterdam, The Netherlands; www.philips.com) Philips Medical Tablet with IntelliVue XDS software is designed to enable remote access to patient monitoring information outside of the hospital setting via wireless (WiFi) connectivity. The tablet runs on Microsoft (Redmond, WA, USA; www.microsoft. com) Windows 10, making it easy to deploy and integrate into existing clinical structures and workflows, including electronic medical records (EMRs), lab results, picture archiving and communication systems (PACS), and third-party information.

It can be also used as an extended screen, working as a companion to smaller or transport monitor, such as an IntelliVue X3 or MX100 monitor, in post-operative care or step-down units. As a clinical workspace that combines monitoring views and the hospital’s IT applica-

tions, clinicians can simultaneously use it to interact across multiple systems. The Philips Medical Tablet can also connect to multiple monitors across the same network, allowing clinicians to remotely monitor a multitude of patients, thus minimizing contact with potential pathogens and reducing personal protective equipment (PPE) changes.

“As clinicians work to navigate increased workloads, safety concerns, and transitions to remote care settings, they require solutions that map to these increasingly challenging circumstances,” said Peter Ziese, general manager of monitoring analytics at Philips. “The Philips Medical Tablet with IntelliVue XDS software gives clinicians critical patient data like vital signs and clinical decision support applications right at their fingertips, empowering them to make informed care decisions no matter where they are.”

The COVID-19 pandemic has created a variety of challenges across multiple care settings within the hospital, including higher than nor-

mal patient volume in emergency rooms, personnel shortages, reduced bed capacity and limited resources, particularly personal protective equipment (PPE). These challenges often lead to overcrowding, increased clinician workload, demand on resources and the added obstacle of trying to create separation between infected and non-infected patients to minimize the spread of disease.

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Functional Plate System Treats Distal Radius Fractures

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ynamic fragment reduction technology assists surgeons to precisely align broken bones, including volar tilt and articular congruity.

The McGinley Orthopedics (Casper, WY, USA; www.mcginleyortho pedicinnovations.com) Lever Action Plate System is designed to optimize fragment alignment and deliver independent fixation of the central and radial column. Contoured to sit just proximal to the watershed line on the distal radius, the dynamic reduction tool uses one or two subchondral beams to dynamically align volar tilt. The beams elevate the lunate and scaphoid facets--independently or together--allowing not only restoration of anatomic volar tilt, but also reduction of die-punch, sagittal, and coronal split fractures in situ.

The system comes with optional variable angle screws of varying sizes with patented locking technology, and can also be used for subchondral fixation. It is intended for use in combination with the IntelliSense Drill, an orthopedic drill that uses integrated sensors to provide the surgeon accurate drill bit location and depth information by identifying three different bone layers, the proximal hard outer cortical layer, the soft, non-resistant medullary layer, and finally the distal hard outer cortical layer.

“This technology allows surgeons to easily align complex wrist fractures with a twist of a dial. The ability to dial in the volar tilt is a game changer,” said orthopedic surgeon Dan Zlotolow, MD, of Shriners Hospitals for Children (Philadelphia, PA, USA), who worked with engineers at McGinley Orthopedics to develop the system, and who implanted the first plate in the United States in February 2021. “The surgery was a great success. This young snowboarder is now reaping the benefits of this innovative technology.”

Current techniques for treating radial fractures are imprecise, resulting in inferior anatomic alignments, which can lead to traumatic arthritis. Failure to restore an alignment also risks placement of screws in unsatisfactory positions, including within the wrist joint. In some cases, the patient may need a repeat surgery to revise the alignment and replace the conventional plate, further increasing the chances of stiffness and/ or traumatic arthritis.

Tiny Cardiac Implant Closes Congenital Heart Defects

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minimally invasive transcatheter implant the size of a pea closes patent ductus arteriosus (PDA) in premature infants.

The Abbott (Abbott Park, IL, USA; www.abbott.com) Amplatzer Piccolo Occluder is a PDA closure device made of selfexpanding, nickel-titanium wire single-layer mesh. The occluder is inserted percutaneously and guided into either the aortic or pulmonary artery via an anterograde (venous) approach, which is recommended in neonates weighing less than two kilograms, or via a retrograde (arterial) approach. The Amplatzer Piccolo is intended for infants weighing over 700 grams and more than three days old.

The tightly woven device closes the congenital shunt immediately after placement, and subsequently integrates fully into the tissue, obviating the need for additional procedures related to the PDA. Features include intaglio wire treatment to reduce nickel leaching, extremely low-profile delivery that facilitates delivery in small vasculatures using a 4 F catheter, a symmetrical design that offers procedural flexibility, and predictable placement thanks to a disc size that facilitate positioning in the duct.

“The Piccolo Occluder greatly increases our ability to close PDAs in the tiniest, most medically fragile babies, offering better options for patients who need corrective treatment and are high risk to undergo heart surgery,” said pediatric interventional cardiologist Jeremy Ringewald, MD, of St. Joseph’s Children’s Hospital (Tampa, FL, USA). “Since the device is implanted through a minimally invasive procedure, many of the premature babies who are critically ill in the neonatal intensive care unit can be weaned from the breathing machine soon after the procedure.”

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Image: Dr. Dan Zlotolow and the first Lever Action Plate implanted RS TO LY IBUO APP R T T DIS TED I INV

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Diamond Studded Ablation System Treats Atrial Fibrillation

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novel radiofrequency (RF) ablation system treats patients with recurrent, symptomatic paroxysmal atrial fibrillation (PAF) unresponsive to drug therapy.

The Medtronic (Dublin, Ireland; www. medtronic.com) DiamondTemp Ablation (DTA) is a temperature-controlled, open-irrigated RF ablation system embedded with industrial-grade diamonds, which have 200-400 times greater thermal conductivity (compared to conventional RF ablation catheters), enabling a low irrigation flow-rate and accurate real-time measurements of tissue temperature; the result is more efficient energy delivery. The DTA also delivers continuous real-time feedback and high-resolution electrogram (EGM) signals as a physical indicator of lesion formation, as well as guidance for ablation location.

In a study involving 482 patients with recurrent, symptomatic PAF that compared the DTA system to a contact force-sensing ablation system, DTA demonstrated a complication-free rate of 96.7%, versus 93.4% in controls, with

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primary effectiveness met in 79.1% and 75.7%, respectively. Additionally, the DTA system demonstrated procedural advantages compared to the control group, with shorter total RF times and individual RF ablation duration, and a reduction in volume of infused saline. The study was published in the in January 2021 issue of Journals of the American College of Cardiology (JACC) Clinical Electrophysiology.

“The DIAMOND-AF trial results are encouraging not only because the DTA system was shown to be safe and effective, but because the outcomes underscored significant procedural efficiencies for clinicians,” said senior author Tom McElderry, MD, of the University of Alabama (Birmingham, USA). “Improved efficiencies, including shorter total RF ablation times and individual RF ablation durations, are important for both the well-being of the patient

and the productivity of the physician and lab staff.”

“Medtronic continues to drive clinical research and innovation to find differentiated solutions that meet the needs of patients and clinicians, who are on the front lines of patient care,” said Rebecca Seidel, president of cardiac ablation solutions at Medtronic. “DTA is the only FDA-approved, temperature-controlled, irrigated RF ablation system on the market today.

The addition of DTA will enable Medtronic to continue to expand our portfolio in new ways with cutting edge arrhythmia solutions to help patients control their AF.” AF ablation using RF energy is a minimally invasive approach to create lesions (scar tissue) that interrupt irregular electrical signals in the heart, in a procedure known as pulmonary vein isolation (PVI). Since the pulmonary veins are often the major source of the cardiac arrhythmia, PVI via catheter ablation remains the cornerstone treatment for AF patients who are unresponsive to drug therapy.

Intercostal Space Guide Supports Emergency Thoracostomies

n innovative device improves the accuracy of lateral decompression needle and chest tube placement during thoracostomy procedures.

The SAM Medical (Wilsonville, OR, USA; www.sammedical.com) ThoraSite is an anatomical landmark guide that is designed to provide a safer approach to the pleural space during emergency procedures, such as the treatment of collapsed lungs and chest wounds following pneumothorax, hemothorax, and similar conditions. In such emergency situations, field providers often consume valuable time counting ribs to identify the appropriate intercostal space for a lateral thoracostomy. The ThoraSite aids them by referencing the patient’s own anatomical landmarks to position a Safe Zone Window (SZW)

directly over the ideal procedure site.

The disposable guide uses two known axes in order to orient itself to a perpendicular intersection point above the intercostal area; the first axis positions the ThoraSite accurately between the anterior axillary and midaxillary line, while the second axis aligns the window over the 3rd, 4th, or 5th intercostal space. An arrow aligns the guide with the anterior iliac crest/hip, while an axilla hook aligns it along the anterior axillary line/midaxillary axis. The dual-sided laminated device is also optimized for low-light conditions, compatible with night vision devices, and suitable for X-rays imaging.

“In time sensitive situations there needs to be a simplified, efficient solution to identify the appropriate intercostal spaces and simplify the cognitive burden associated with tho-

racostomies,” commented Sam Scheinberg, MD, founder and CEO of SAM Medical.

“ThoraSite was developed to address this problem. ThoraSite reduces procedure time by quickly facilitating procedure site location, increases likelihood of appropriate needle/ tube placement, and decreases iatrogenic injury.”

An estimated 50,000 injuries per year and one in four trauma deaths is directly the result of thoracic injuries, with thoracic trauma is a contributing factor in another 25% of trauma patients who die of their injuries. Correctly performed lateral emergency needle thoracostomies, which are commonly performed in the prehospital and emergency department setting, could help reduce this mortality rate.

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Annuloplasty Ring Advances Mitral Valve Repair

Surgical Techniques

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n implanted circumferential mitral valve ring reshapes and resizes annular geometry, facilitating leaflet edge-to-edge repair.

The Valcare Medical (Herzliya, Israel; www.valcaremedical.com) AMEND annuloplasty device is based on a D-shaped ring designed to reduce valvular incompetence, using a proprietary remote mechanism that controls the shape of the ring by modifying its geometry, using a series of four independently deployed anchors in different zones that attach the ring to the mitral valve annulus. The device is delivered using a proprietary catheter through the chest and into the heart under ¬fluoroscopic and echo guidance via sub-xiphoid transapical or transseptal delivery.

The implant emerges from the catheter in a linear form and transforms into the closed D-shape ring in the heart’s left atrium. Once deployed, the ring is re-positioned to match the annulus of the original mitral valve, and the septal lateral (anterior-posterior) dimension is further reduced for better lea¬flet coaptation to eliminate mitral regurgitation. Endothelization and ingrowth both around and within the implant aid structural integrity and long-term performance. The AMEND device is currently limited to investigational use, and is not commercially available.

“AMEND’s distinctive design provides a transcatheter surgical-like solution and creates a platform for multiple treatment options for patients, as a stand-alone solution or in combination with edge-to-edge or chordal reconstruction therapies,” said Shuki Porath, CEO of Valcare Medical. “The AMEND platform also serves as infrastructure for Valcare’s mitral replacement system and tricuspid repair solution.”

Mitral valve regurgitation, the most common form of valvular heart disease, is a disorder of the heart in which the valve does not close properly, causing regurgitation of blood from the left ventricle through the mitral valve and into the left atrium when the left ventricle contracts, causing blood to return back into the left atrium.

Image: The AMEND mitral repair annuloplasty ring (Photo courtesy of Valcare Medical)

Innovative Spinal Implant Mimics Honeycomb Structure

A

novel Titanium (Ti) cervical interbody implant is modeled on a honeycomb pattern, encouraging bony ingrowth into the graft spaces.

The NGMedical (Nonnweiler, Germany; www.ngmedical.de) cervical BEE 3D cage features a lightweight, open, anatomical design with hexagonal honeycomb endplates that promote optimal primary fixation by surface contact and pins, and encourages bony fusion.

The intelligent honeycomb endplate design helps reduce the risk of subsidence significantly, while enhancing fusion, and also minimizes the risk of X-ray artefacts, due to a reduced Ti content.

“The BEE cage provides maximum surface area due to the honeycomb structure and laterally accessed lumen,” said Josh Sandberg of NGMedical.

“This implant, along with its streamlined and elegant instrumentation, is perfectly suited, as it addresses every key metric, including anatomical design for bony fusion, maximum porosity with improved imaging, and increased surface area minimizing subsidence.”

Interbody fusion devices are a prosthesis used in spinal fusion procedures, replacing the intervertebral disc and enhancing stability in the region by maintaining foraminal height and decompression while the spine fuses. Once placed, the cages resist flexion and extension forces, as well as axial forces across the ventral and middle columns. Over time, the packed bone graft material is gradually replaced by natural bone, forming a solid section.

Image: The BEE 3D interbody cervical implant (Photo courtesy of NGMedical)

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The LED5 MC large surgical light with LED technology provides high contrast and a life-like as well as precise illumination of the surgical field. It is available as multi-color LED (MC) and with a multi-facetted lens system.

The Smarter Practico is a versatile operating table that has been designed to improve ergonomics with the widest range of posture possibilities and is powered by smart controls that help work more fluently.

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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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 (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 that allow the surgeon to conveniently reach up and make quick adjustments. A touch-free

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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)

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.

HospiMedica International February-March/2021

24

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Industry News

Market for AI in Medical Imaging to Reach USD 1.5 Billion by 2024

T

he global market for AI-based clinical applications for use in medical imaging is set to reach almost USD 1.5 billion by 2024 despite a slower-than-expected uptake of these products and the impact of the COVID-19 pandemic.

The market growth is projected to accelerate as the pandemic subsides and customer confidence in AI-based clinical solutions increases, with a peak annual growth rate of 44% forecast for 2022. These are the latest findings of Signify Research (Cranfield, UK; www.signifyresearch. net), an independent supplier of market intelligence and consultancy to the global healthcare technology industry.

In 2019, 86% of the world market for AI-based clinical applications for medical imaging was accounted for by four clinical specialties (in order of market size): cardiology, neurology, breast, and pulmonology.

Cardiology is forecasted to enjoy the largest revenue growth, followed by pulmonology, and these four clinical segments are projected to still account for more than 75% of the market in 2024. However, new product introductions of AI solutions for other clinical segments, most notably prostate and liver imaging, are on the rise.

Until now, the growth of the global market for AI-based clinical applications for use in medical imaging has been less rapid than anticipated by several industry experts due to several technical and commercial barriers, and a further set back dealt by the COVID-19 global pandemic. These barriers to market adoption, including the utility of AI in clinical practice, lack of clinical validation, challenges of workflow integration, and limited reimbursement, must be fully addressed before the use of AI in radiology becomes mainstream.

“The market is highly dynamic and continues to evolve at a rapid pace, said Dr. Sanjay Parekh. Senior Analyst at Signify Research. “There

R

Philips Acquires Medical Device Integrator in the U.S.

oyal Philips (Amsterdam, the Netherlands; www.philips.com) has signed an agreement to acquire Capsule Technologies, Inc. (Andover, MA, USA; www.capsuletech.com), a provider of medical device integration and data technologies for hospitals and healthcare organizations.

Capsule’s Medical Device Information Platform - comprised of device integration, vital signs monitoring and clinical surveillance services - connects almost all existing medical devices and EMRs in hospitals through a vendor-neutral system. Capsule’s platform captures streaming clinical data and transforms it into actionable information for patient care management to enhance patient outcomes, improve collaboration between care teams, streamline clinical workflows and increase productivity. Capsule serves over 2,800 hospitals and healthcare organizations in 40 countries across the world.

Philips will acquire Capsule for a cash consideration of USD 635 million (approximately EUR 530 million). The acquisition of Capsule is a strong fit with Philips’ strategy to transform the delivery of care along the health continuum with integrated solutions. Philips’ current portfolio already includes real-time patient monitoring, therapeutic devices, telehealth, informatics and interoperability solutions. The combination of Philips’ industry-leading portfolio with Capsule’s leading Medical Device Information Platform, connected through Philips’ secure vendor-neutral cloud-based HealthSuite digital platform, will greatly enrich and scale Philips’ patient care management solutions for all care settings in the hospital, as well as remote patient care.

“Integrated patient care management solutions supported by essential real-time patient data and AI are core to our strategy to improve patient outcomes and care provider productivity by seamlessly connecting care,” said Roy Jakobs, Chief Business Leader Connected Care at Royal Philips.

“The acquisition of Capsule will further expand our patient care management offering. We look forward to integrating our strengths, adding a vendor-neutral medical device integration platform that further unlocks the

25

are frequent product launches, and the availability of regulatory approved products is accelerating. Since 2018, almost 60 AI-based clinical applications for medical imaging have received US-FDA approval, while a similar number of solutions have received CE Mark approval.”

Despite the many challenges of bringing medical imaging AI solutions to market, “radiology AI is here to stay,” added Dr. Parekh. “From enhanced productivity and increased diagnostic accuracy, to more personalized treatment planning and improved clinical outcomes, AI will play a key role in enabling radiologists to meet the demands of their workload. The increasing volume of diagnostic imaging procedures, exacerbated by the current backlog of imaging exams due to national lockdowns, coupled with the shortage of radiologists in many countries, will undoubtedly further increase the need for AI in radiology.”

HospiMedica International February-March/2021

power of medical device data to enhance patient monitoring and management, improve collaboration and streamline workflows in the ICU, as well as other care settings in the hospital and beyond its walls.”

“We are very excited to become part of Philips and step up on our goal of empowering clinicians with simplified workflows and timely, actionable insights,” said Hemant Goel, CEO of Capsule Technologies. “Together, we will be even better positioned to liberate, aggregate, analyze, and share clinical data from connected devices that will support clinicians making more informed decisions, and ultimately drive the transformation from reactive care to insight-driven, proactive care delivery.”

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