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WORLD’S CLINICAL NEWS LEADER ISSN 0898-7270 Vol.40 No.1 • 2-3/2022
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Avoiding Heart Valve Replacement Surgery
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novel technology could prevent repeat operations to replace a faulty bioprosthetic heart valve, thus helping many patients implanted with bioprosthetic heart valves by avoiding additional complicated replacement surgery.
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Report Identifies Nine Trends to Drive Diagnostic Imaging in 2022
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lliance Healthcare Services (Irvine, CA, USA; www.alli ancehealthcareservices-us.com), a provider of outsourced healthcare services offering diagnostic radiology services, has identified nine trends driving diagnostic imaging in 2022.
Most significantly, Alliance predicts PET/CT to come into focus in 2022. Imaging volumes are returning to pre-pandemic levels despite cyclical COVID disruptions. Amid the volume ups and downs, PET/CT is likely to come into focus. Alliance expects
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Deep-Learning Technique Predicts Clinical Treatment Outcomes
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attery-free, wireless smart sutures can promote healing and monitor wound integrity, gastric leakage, and tissue micro-motion at the same time, claims a new study. Developed at National University of Singapore (NUS; Singapore; www.nus.edu.sg), the new sutures have three key components: a medical-grade multifilament silk suture coated with a conductive polymer to allow it to respond to wireless
reast cancer is one of the leading causes of cancer death in women and a major socioeconomic issue throughout the world. With the detection methods available today, diagnosing breast cancer early enough is still not possible in many cases. As well as the problem of detection, there is an ever-increasing need for improved non-invasive characterization of cancer. Targeted therapies require Cont’d on page 11
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Bioelectronic Sutures for Deep Surgical Wounds
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Hybrid PET/MRI Aids Breast Cancer Diagnosis
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breakthrough deep-learning technique called G-Net simulates counterfactual, time-varying, and dynamic treatment strategies, allowing doctors to choose the best course of action.
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Blood Oxygenator Minimizes Need For Invasive Mechanical Ventilation
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n early extracorporeal respiratory support system that elevates oxygen saturation levels is designed to be a new standard of care as a second-line treatment to minimize the need for invasive mechanical ventilation (MV).
GE Healthcare Acquires BK Medical, Expanding Ultrasound Offerings
E Healthcare has completed its previously announced acquisition of BK Medical in a deal that would expand its ultrasound business from diagnostics into surgical and therapeutic interventions. With this acquisition, GE adds
COVID-19 Update. . . . . 4 News Update. . . . . . . . . . 9 Product News . . . . . . . 6-12
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the fast-growing and relatively new field of real-time surgical visualization to GE’s pre- and post-operative ultrasound capabilities, creating an end-to-end offering through the full continuum of care – from diagnosis through therapy and beyond. Cont’d on page 9
News Update. . . . . . . . . 15 Product News . . . . . . 14-18
News Update. . . . . . . . . 21 Product News . . . . . . 20-24
Industry News. . . . . . . . . . 25 International Calendar . . . 26
GLOBETECH >>> MEDIA <<<
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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 November 1, 2021 until February 15, 2022. For a recap of earlier developments, the reader is invited to refer to previous issues of HospiMedica or visit www. HospiMedica.com. First-Ever Molecules that Target SARS-CoV-2 RNA and Prevent Replication Could Cure COVID-19 Researchers at Duke University (Durham, N.C., USA; www.duke. edu) are working on new ways to cure COVID-19 infections, such as using molecules that bind to folds in the SARS-CoV-2 virus’s RNA genome. The researchers believe that the complex shapes that RNA takes on as it folds upon itself could have untapped therapeutic potential in the fight against COVID-19. The team has identified chemical compounds that can latch onto these 3D structures and block the virus’s ability to replicate. New Algorithm Identifies COVID-19 Patients Who Will Require Intensive Care or Ventilation With 90% Accuracy A new algorithm developed by researchers from the University of Copenhagen (Copenhagen, Denmark; www.ku.dk) can predict how many patients will need intensive COVID-related healthcare. The innovative algorithm will help alleviate pressure whenever hospitals are confronted by new waves of COVID. It could provide valuable knowledge when it comes to prioritizing caregivers and ventilators in individual hospitals, and save lives. The algorithm can predict the course of COVID patients’ illnesses in relation to how many of them will be highly likely or unlikely to require intensive care or ventilation. This is important for the allocation of staff across hospitals.
Delivering COVID-19 Vaccines via Suctioning Technique May Help Generate Higher Antibody Levels A team of researchers studying COVID-19 at Rutgers University (New Brunswick, NJ, USA; www.rutgers.edu) have created a new way to deliver DNA molecules into skin cells, using a suction technique similar to the ancient healing practice of cupping. In laboratory tests with rodents, the researchers used the suction method to deliver a SARS-CoV-2 DNA vaccine, which generated a strong immune response - about 100 times stronger than an injected vaccine alone. AI Combined with Genomic Surveillance Beats Humans at Detecting Infectious Disease Outbreaks in Hospital Settings By coupling machine learning with whole genome sequencing, scientists at the University of Pittsburgh School of Medicine (Pittsburgh, PA, USA; www.upmc.com) and Carnegie Mellon University (Pittsburgh, PA, USA; www.cmu.edu) have greatly improved the quick detection of infectious disease outbreaks within a hospital setting over traditional methods for tracking outbreaks. The process indicates a way for health systems to identify and then stop hospital-based infectious disease outbreaks in their tracks, cutting costs and saving lives. Novel Extracorporeal Oxygenation System Could Become First Respiratory Device to Substitute Mechanical Ventilation A novel low-flow early extracorporeal blood oxygenation system developed by Inspira Technologies (Ra’anana, Israel; www.inspirao2. com) intends to offer acute respiratory patients, who continue to deteriorate following non-invasive ventilation treatment, creating a new alternative to invasive mechanical ventilation. Inspira has filed a Patent Cooperation Treaty (PCT) patent application for its novel ART device and its proprietary methods of use to minimize the need for invasive mechanical ventilation which requires intubation and induced coma.
Potential New Treatment That Suppresses Replication of SARS-CoV-2 Could Be a Breakthrough in COVID-19 Therapy
Respiratory Discovery Could Improve Survival of COVID-19 Intensive Care Patients
Researchers at the University of Kent’s School of Biosciences (Canterbury, UK; www.kent.ac.uk) and the Institute of Medical Virology at Goethe-University (Frankfurt, Germany; www.gerit.org) have identified a potential new treatment that suppresses the replication of SARS-CoV-2. Their research has revealed that cells infected with SARS-CoV-2 can only produce novel coronaviruses when their metabolic pentose phosphate pathway is activated. When applying the drug benfooxythiamine, an inhibitor of this pathway, SARS-CoV-2 replication was suppressed and infected cells did not produce coronaviruses.
A clinical trial at the University of Southampton (Southampton, UK; www.southampton.ac.uk) and University College London (London, UK; www.ucl.ac.uk) has revealed one reason why COVID-19 patients on ventilators have trouble breathing, and how refining a treatment couldhelp save lives. The COVID-19 virus latches onto cells deep in our lungs that produce surfactant – a complex mixture which lines our lungs’ air sacs and is essential for breathing. The trial has shown COVID-19 Cont’d on page 4
Portable Air Filters Effectively Remove SARS-CoV-2 Particles from Hospital Air in COVID-19 Surge Units In the world’s first live study, researchers at Addenbrooke’s Hospital (Cambridge, UK; www.cuh.nhs.uk) have demonstrated that MAXVAC’s (Zurich, Switzerland; www.max-vac.com) Medi 10 range of COVID busting mobile air purifiers can remove COVID-19 aerosols and other microbial bioaerosols from the environment. The study confirmed the efficacy of MAXVAC’s Medi purifiers and that they can successfully trap and kill the COVID virus, although up until very recently, no published trials had been carried out with COVID itself (just lookalike viruses). Pfizer’s Novel COVID-19 Pill Cuts Risk of Hospitalization or Death by 90% Pfizer Inc.’s (New York, NY, USA; www.pfizer.com) investigational novel COVID-19 oral antiviral candidate has been found to reduce the risk of hospitalization or death by 89% compared to placebo in non-hospitalized high-risk adults with COVID-19. Pfizer’s PAXLOVID is an investigational SARS-CoV-2 protease inhibitor antiviral therapy, specifically designed to be administered orally so that it can be prescribed at the first sign of infection or at first awareness of an exposure, potentially helping patients avoid severe illness which can lead to hospitalization and death.
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COVID-19 Update Cont’d from page 3
patients on ventilators had less surfactant, and discovered why giving extra surfactant doesn’t always work. They suggest that, by giving surfactant for longer, more intensive care patients could survive. Innovative X-Ray Imaging Showing COVID-19 Vascular Damage Could Support Routine Lab Diagnostics An innovative X-ray imaging technique that shows COVID-19 can cause vascular damage to the heart could support pathologists with routine diagnostics, according to a study by an interdisciplinary research team from the Göttingen University (Göttingen, Germany; www.uni-goet tingen.de) and Hannover Medical School (Hannover, Germany; www.hannover.de). The current study detected significant changes in the heart muscle tissue of people who died from COVID-19 and underpins the involvement of the heart in COVID-19 at the microscopic level for the first time by imaging and analyzing the affected tissue in the three dimensions. World’s First Molecular-Level Analysis of Omicron Spike Protein to Help Develop Variant-Resistant COVID-19 Treatments Researchers from The University of British Columbia (Vancouver, BC, Canada; www. ubc.ca) have become the first in the world to conduct a molecular-level structural analysis of the Omicron variant spike protein. The analysis—done at near atomic resolution using a cryo-electron microscope—reveals how the heavily mutated variant infects human cells and is highly evasive of immunity. The findings shed new light on why Omicron is highly transmissible and will help accelerate the development of more effective treatments. Discovery of Omicron Neutralizing Antibodies Could Lead to Effective Treatments for COVID-19 Variants
U.S. Environmental Protection Agency (EPA) to begin commercial deployment of AURA, the company’s novel, automated device disinfectant system that can help improve the safety of healthcare workers and patients by reducing exposure to COVID-19 and other healthcare associated pathogens. AURA system is believed to be the first registered, automated, point-of-care solution providing fast disinfection for non-critical medical devices and common articles used in the healthcare environment. It replaces the need for cumbersome and often challenging manual disinfection with wipes, reducing exposure of health care workers and patients alike to pathogens that cause healthcare associated infections (HAI).
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A new technique pioneered by researchers at The University of British Columbia (Vancouver, BC, Canada; www.ubc.ca) combines machine learning and AI to rapidly detect sepsis. The groundbreaking advance in quickly detecting sepsis using machine learning could dramatically cut the risk of death from one of the biggest killers in the world that is responsible for one in five deaths worldwide, including those from severe COVID-19 disease. AI-Based Early Warning System Detects Potential High-Risk SARSCoV-2 Variants BioNTech SE (Mainz, Germany; www. biontech.de) and InstaDeep Ltd. (London, UK; www.instadeep.com) have developed an Early Warning System (EWS) that combines spike protein structural modeling with artificial intelligence (AI) to detect and monitor high-risk SARS-CoV-2 variants. The new computational method analyses worldwide available sequencing data and predicts high-risk variants of SARS-CoV-2. Moderna to Roll out Combined COVIDFlu-RSV Booster Vaccine in Late 2023
Automated, POC Disinfectant System Helps Combat COVID-19 and Healthcare Associated Pathogens
Blood drawn from patients shortly after they were infected with SARS-CoV-2, the virus that causes COVID-19, may indicate who is most likely to land in the hospital, according to a new study by researchers at Stanford Cont’d on page 6
Moderna Inc. (Cambridge, MA, USA; www. modernatx.com) is developing a single vaccine that combines a booster dose against COVID-19 with its experimental flu shot. The new vaccine will combine the experimental flu shot that is furthest along with its COVID-19 vaccine. In the best case scenario, the company expects its combined COVID/flu vaccine to be available in time for the winter infectious season in 2023, at least in some countries. Blood Test to Measure Antibodies Soon After Positive COVID-19 Result May Predict Severity
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In a research project supported by the Howard Hughes Medical Institute (Chevy Chase, MD, USA; www.hhmi.org), scientists have identified antibodies that neutralize Omicron and other SARS-CoV-2 variants, raising hopes of the findings leading to the development of more effective vaccines and antibody treatments for COVID-19 variants. The researchers identified the antibodies which target areas of the virus spike protein that remain essentially unchanged as the viruses mutate. By identifying the targets of these “broadly neutralizing” antibodies on the spike protein, it might be possible to design vaccines and antibody treatments that will be effective against not only the Omicron variant but other variants that may emerge in the future.
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ISSN 0898-7270
Vol.40 No.1 • Published, under license, by Globetech Media LLC Copyright © 2022. All rights reserved. Reproduction in any form is forbidden without express permission. Teknopress Yayıncılık ve Ticaret Ltd. Şti. adına İmtiyaz Sahibi: M. Geren • Yazı işleri Müdürü: Ersin Köklü Müşir Derviş İbrahim Sok. 5/4, Esentepe, 34394 Şişli, İstanbul P. K. 1, AVPIM, 34001 İstanbul • E-mail: Teknopress@yahoo.com Baskı: Postkom A.Ş. • İpkas Sanayi Sitesi 3. Etap C Blok • 34490 Başakşehir • İstanbul Yerel süreli yayındır. Yılda dört kere yayınlanır, ücretsiz dağıtılır.
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PRODUCT NEWS
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COVID-19 Update Cont’d from page 4
Medicine (Stanford, CA, USA; www.med.stanford.edu). The researchers looking at antibodies in patients soon after they were infected with the virus that causes COVID-19 found key differences between those whose cases remained mild and those who later developed severe symptoms. Groundbreaking AI Technology Accurately Diagnoses COVID-19 Using Chest X-Rays in Minutes A pioneering artificial intelligence (AI) technology developed by researchers at University of the West of Scotland (UWS; Scotland, UK; www.uws.ac.uk) is capable of accurately diagnosing COVID-19 in just a few minutes. The groundbreaking program is able to detect the virus far more quickly than a PCR test; which typically takes around two hours. It is hoped that the technology can eventually be used to help relieve strain on hard-pressed accident and emergency departments, particularly in countries where PCR tests are not readily available. Machine Learning Model Uses Blood Tests to Predict Survival of Critically Ill COVID-19 Patients A single blood sample from a critically ill COVID-19 patient can be analyzed by a machine learning model which uses blood plasma proteins to predict survival, weeks before the outcome, according to a new study by scientists at the Charité-Universitätsmedizin Berlin (Berlin, Germany; www.charite.de). The study found that the levels of 14 proteins in the blood of critically ill COVID-19 patients are associated with survival. Lung Ultrasound as Good as Chest X-Ray for COVID-19 Diagnosis and Management A retrospective multicenter study by researchers from Italy, Portugal and Spain has found lung ultrasound (LUS) to be as good as chest X-ray (CXR) for accurate COVID-19 diagnosis. LUS holds the promise of an accurate, radiation-free, and affordable diagnostic and monitoring tool in coronavirus disease 2019 (COVID-19) pneumonia. The study found LUS to be non-inferior to CXR for diagnostic accuracy and COVID-positive patients were most likely to show B lines and sub-pleural consolidations on LUS examination.
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Scoring System Helps Predict Stroke Risk for Hospitalized COVID-19 Patients Researchers at Weill Cornell Medical College (New York, NY, USA; www.weill.cornell.edu) used information from the COVID-19 Registry of the American Heart Association (Dallas, TX, USA; www. heart.org) to develop a new scoring system can help predict the risk of stroke among adults hospitalized with COVID-19 and is comparable to a computer-based risk estimator. To verify the accuracy of the scoring system, the results were compared to a computer method based on artificial intelligence. The clinical scoring system predicted the risk of stroke as accurately as the computer method. Hyperpolarized Xenon MRI Scans Detect Abnormalities in Lungs of Long COVID Patients Using hyperpolarized xenon MRI, researchers at the University of Sheffield (Sheffield, UK; www.sheffield.ac.uk) and University of Oxford (Oxford, UK; www.ox.ac.uk) have identified abnormalities in the lungs of long COVID patients with breathlessness but whose other tests are normal. These early results suggest that COVID-19 may result in persistent impairment in gas transfer and underlying lung abnormalities. However, the extent to which these abnormalities contribute to breathlessness is currently unclear. New Light on Molecular Factors Related to SARS-CoV-2 Variants Could Improve COVID-19 Management Researchers at the University of British Columbia (Vancouver, BC Canada; www.ubc.ca) are shedding new light on the molecular factors that give variants of SARS-CoV-2 a competitive edge essential knowledge that could improve disease management as new variants continue to emerge. Their findings help explain how the Delta variant may have been able to beat out the Kappa variant and become dominant across the globe. New Guidelines Proposed for Mechanical Ventilators that Can Work in Low- and Middle-Income Countries An original survey led by King’s College London (London, UK; www.kcl.ac.uk) of more than 50 expert anesthetists and intensivists from 23 low- and middle-income countries (LMICs) in Africa, Asia, Central and South America, and on a critical analysis of the published literature, has led to the proposal of new guidelines to design mechanical ventilators that can work in LMICs. The findings of the study are vital for countries that have few mechanical ventilators, as low ventilation capacity limits access to critical care and surgery. HospiMedica International February-March/2022
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Deep-Learning Technique Predicts Clinical Treatment Outcomes
new deep-learning technique simulates counterfactual, time-varying, and dynamic treatment strategies, allowing doctors to choose the best course of action. The deep-learning technique, called G-Net, from researchers at MIT-IBM Watson AI Lab (Cambridge, MA, USA), provides a window into causal counterfactual prediction, affording physicians the opportunity to explore how a patient might fare under different treatment plans. The foundation of G-Net is the g-computation algorithm, a causal inference method that estimates the effect of dynamic exposures in the presence of measured confounding variables - ones that may influence both treatments and outcomes. Unlike previous implementations of the g-computation framework, which have used linear modeling approaches, G-Net uses recurrent neural networks (RNN), which have node connections that allow them to better model temporal sequences with complex and nonlinear dynamics, like those found in the physiological and clinical time series data. In this way, physicians can develop alternative plans based on patient history and test them before making a decision. To build, validate, and test G-Net’s predictive abilities, the researchers considered the circulatory system in septic patients in the ICU. During critical care, doctors need to make trade-offs and judgment calls, such as ensuring the organs are receiving adequate blood supply without overworking the heart. For this, they could give intravenous fluids to patients to increase blood pressure; however, too much can cause edema. Alternatively, physicians can administer vasopressors, which act to contract blood vessels and raise blood pressure. In order to mimic this and demonstrate GNet’s proof-of-concept, the team used CVSim, a mechanistic model of a human cardiovascular system that’s governed by 28 input variables characterizing the system’s current state, such as arterial pressure, central venous pressure, total blood volume, and total peripheral resistance, and modified it to simulate various disease processes (e.g., sepsis or blood loss) and effects of interventions (e.g., fluids and vasopressors). The researchers used CVSim to generate observational patient data for training and for “ground truth” comparison against counterfactual prediction. In their G-Net architecture, the researchers ran two RNNs to handle and predict variables that are continuous, meaning they can take on a range of values, like blood pressure, and categorical variables, which have discrete values, like the presence or absence of pulmonary edema. The researchers simulated the health trajectories of thousands of “patients” exhibiting symptoms under one treatment regime, let’s say A, for 66 timesteps, and used them to train and validate their model. Testing G-Net’s prediction capability, the team generated two counterfactual datasets. Each contained roughly 1,000 known patient health trajectories, which were created from CVSim using the same “patient” condition as the starting point under treatment A. Then at timestep 33, treatment changed to plan B or C, depending
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on the dataset. The team then performed 100 prediction trajectories for each of these 1,000 patients, whose treatment and medical history was known up until timestep 33 when a new treatment was administered. In these cases, the prediction agreed well with the “ground-truth” observations for individual patients and averaged population-level trajectories. Since the g-computation framework is flexible, the researchers wanted to examine G-Net’s prediction using different nonlinear models - in this case, long short-term memory (LSTM) models, which are a type of RNN that can learn from previous data patterns or sequences - against the more classical linear models and a multilayer perception model (MLP), a type of neural network that can make predictions using a nonlinear approach. Following a similar setup as before, the team found that the error between the known and predicted cases was smallest in the LSTM models compared to the others. Since G-Net is able to model the temporal patterns of the patient’s ICU history and past treatment, whereas a linear model and MLP cannot, it was better able to predict the patient’s outcome. The team also compared G-Net’s prediction in a static, time-varying treatment setting against two state-of-the-art deep-learning based counterfactual prediction approaches, a recurrent marginal structural network (rMSN) and a counterfactual recurrent neural network (CRN), as well as a linear model and an MLP. For this, they investigated a model for tumor growth under no treatment, radiation, chemotherapy, and both radiation and chemotherapy scenarios. For these investigations, the researchers generated simulated observational data using tumor volume as the primary influence dictating treatment plans and demonstrated that G-Net outperformed the other models. One potential reason could be because g-computation is known to be more statistically efficient than rMSN and CRN, when models are correctly specified. While G-Net has done well with simulated
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data, more needs to be done before it can be applied to real patients. Since neural networks can be thought of as “black boxes” for prediction results, the researchers are beginning to investigate the uncertainty in the model to help ensure safety. “Our ultimate goal is to develop a machine learning technique that would allow doctors to explore various ‘What if’ scenarios and treatment options,” said Li-wei Lehman, MIT research scientist in the MIT Institute for Medical Engineering and Science and an MIT-IBM Watson AI Lab project lead. “A lot of work has been done in terms of deep learning for counterfactual prediction but [it’s] been focusing on a point exposure setting,” or a static, time-varying treatment strategy, which doesn’t allow for adjustment of treatments as patient history changes. However, her team’s new prediction approach provides for treatment plan flexibility and chances for treatment alteration over time as patient covariate history and past treatments change. “G-Net is the first deep-learning approach based on g-computation that can predict both the population-level and individual-level treatment effects under dynamic and time varying treatment strategies.”
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PRODUCT NEWS
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MRI May Halve Breast-Cancer Mortality Among Women Carrying Certain Genes
Annual MRI screenings starting at ages 30 to 35 may reduce breast-cancer mortality by more than 50% among women who carry certain genetic changes in three genes, according to a new comparative modeling analysis. The predictions by researchers at the University of Washington School of Medicine (Seattle, WA, USA) involve pathogenic variants in ATM, CHEK2 and PALB2 genes – which collectively are as prevalent as the much-reported BRCA1/2 gene mutations. The researchers contend that their findings support MRI screening in some women earlier than existing guidelines propose. To realize a benefit of cancer screening guidelines based on genetic susceptibility, a woman would need to know she carries an implicated gene variant before receiving a disease diagnosis. More often it’s the case that a genetic test panel is administered after someone tests positive for cancer – too late to be of preventive value for the patient but potentially life-saving for blood relatives who could seek genetic testing. Using established breast-cancer simulation models, the researchers input age-specific risk estimates involving more than 32,000 breast-cancer patients and a similar number of patients who had no cancer. The simulations compared the combined performance of mammography and MRI against mammography alone, and projected that annual MRI conferred significant additional benefit to these populations. The simulations in this study also preCont’d on page 13
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DELWORKS LLI improves workflow and decreases patient dose as its extensive image area of 17 x 42 in (43 x 107 cm) enables full spine and long leg imaging with just one exposure.
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Report Identifies Nine Trends to Drive Diagnostic Imaging in 2022
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developments in PET/CT imaging for oncology, cardiology and urology – stemming from new radiopharmaceuticals – to create opportunities for PET/CT providers to drive growth in imaging excellence and innovation in patient care. Alliance anticipates diversification to be the key for players in the diagnostic imaging market. As consolidation and mergers take on new heights, and new players enter healthcare, industry participants will be forced to stay competitive by seeking opportunities to diversify services. Alliance also expects the road to transparency in the diagnostic imaging market to remain unclear in 2022. Federal enforcement of price transparency rules is set to commence this year. The near-term effects may not be disruptive, although Alliance anticipates similar initiatives and policies to upend the market over the long-term. The involvement and knowledge of employers, physicians and patients will pressure plans and providers to respond. Additionally, Alliance expects staffing shortages plaguing companies and industries to continue in the diagnostic imaging market as well in 2022. The demand for highly trained radiology and other healthcare professionals remains strong. Sourcing sufficient and reliable staff to weather current market conditions – and to deliver compassionate, quality patient experiences – will become more important than ever. Alliance also anticipates supply chain stresses in the diagnostic imaging market to continue to permeate in 2022. Traditional supply chain management has become a central concern in healthcare. Radiology providers will need to prepare for supply disruptions and delays through the year. If their size and scale limit
options, they will need to consider end-to-end partnerships that bridge the gap. In 2022, players in the diagnostic imaging market will need to strengthen their value proposition, according to Alliance. Patients are increasingly participating in decisions about where to go for care, especially in radiology. Pandemic-related safety concerns are just one more consideration for patients who have easy access to online resources to compare their choices and imaging services – especially MRI – are highly shopped. Alliance anticipates cybersecurity to be key in the diagnostic imaging market in 2022. An influx of cybersecurity attacks in record numbers had posed new challenges to health systems in 2021. Healthcare executives will need to ensure that extensive measures are in place to address evolving IT threats and patient privacy. Alliance expects mobile radiology solutions to result in the site of care shifting even closer to home in 2022. The recent dramatic adoption of telehealth, accelerated by the pandemic, marks yet another step toward more convenient outpatient care. Patients (and providers) now prefer their home setting for certain appointments. Since flexible hospital-level care at home remains mostly out of reach for now, mobile radiology solutions that improve access are likely to provide patients with quality healthcare close-to-home. According to Alliance, players in the diagnostic imaging market will face wafer-thin margins. Prices are rising on all fronts – from labor to supply costs – and putting pressure on already thin margins. Players in the diagnostic imaging market will need to become more creative and explore strategies, such as partnerships, in order to protect their bottom line. HospiMedica International February-March/2022
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Report Ranks Top Performing Radiology IT Solutions
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LAS Research (Pleasant Grove, UT, USA; www.klasresearch. com), a healthcare IT research firm, has released its 2022 Best in KLAS Report that recognizes software and services companies who excel in helping healthcare professionals improve patient care. Covering more than 1,000 health informatics solutions used across health systems, the report ranks companies across the product categories of radiology on PACS, speech recognition, universal viewers, image exchange software, and vendor neutral archives, based on interviews of clinicians who are the product end-users. In the PACS product category for large healthcare centers with more than 300,000 studies per year, Sectra PACS was the Best in KLAS product with an overall performance score of 88.5, followed by Fujifilm Synapse (84.4), IBM Watson Health Merge PACS (82.3), Change Healthcare Radiology Solutions (80.5), and GE Healthcare Centricity PACS (58.6). KLAS also ranked six other PACS in this category but lacked information for a head-to-head comparison. These included Infinitt PACS with an overall performance score of 88, followed by Philips Vue PACS (Carestream) (79), Intelerad IntelePACS (mostly imaging centers) (78.8), Agfa HealthCare Enterprise Imaging for Radiology (73.9), Agfa HealthCare IMPAX (73.8), and Philips IntelliSpace PACS (66.2). Among the small PACS market classified as healthcare organizations with less than 300,000 studies per year, the Best in KLAS product was Sectra PACS with an overall performance score of 92.8, followed by Novarad NovaPACS (87.9), Philips Vue PACS (Carestream) (87.1), Infinitt PACS (85.2), Fujifilm Synapse (81.8), Change Healthcare Radiology Solutions (81.6), IBM Watson Health Merge PACS (78.4), Intelerad IntelePACS (mostly imaging centers) (74.2), and GE Healthcare Centricity PACS (70.9). KLAS also ranked three other PACS in this category but lacked information for a head-to-head comparison. These included PaxeraHealth PaxeraUltima (used as a component) (89.7), Agfa HealthCare Enterprise Imaging for Radiology (78.5), and Philips IntelliSpace (not used as a primary system) (75.4).
Among the radiology speech recognition platforms included in the KLAS review, the highest ranked was 3M MModal Fluency for Imaging at 89, followed by Dolbey Fusion Expert (88.7) and Nuance PowerScribe 360/One (86.9). Among the top medical imaging universal viewers, the highest end user rank was received by Philips Vue Motion (Carestream) (86), followed by Mach7 Technologies eUnity (85.3), IBM Watson Health IBM iConnect Access (85.2), Agfa HealthCare Enterprise Imaging Xero Viewer (83.2), and GE Healthcare Universal Viewer (72.8). In the category of image exchange software, Intelerad DG Suite (Ambra) ranked best at 92.3, followed by Nuance PowerShare (90.1), IBM Watson iConnect Access image Exchange (76), and LifeImage (65.5). Among vendors of vendor neutral archive (VNA), the Best in KLAS rank went to Fujifilm Synapse VNA (TeraMedica) at 86.3, followed by IBM Watson Health IBM iConnect Enterprise Archive (84.8), Mach7 Technologies Mach7 VNA (80.1), Hyland Acuo (75.2), Agfa HealthCare Enterprise Imaging VNA (74.8), and GE Healthcare Centricity Clinical Archive Solution (73.8).
GE Healthcare Acquires BK Medical, Expanding Ultrasound Offerings
Cont’d from cover
Through significant synergies with the benefit of GE’s technology and commercial scale, BK Medical will be able to reach new customers and markets around the world. BK Medical will join GE and will continue to best serve its customers in the intraoperative ultrasound space in the US, Europe and beyond. “We are thrilled to bring our extraordinary teams together, learn from each other and continue to build on our deep, shared expertise as we grow our portfolio that our customers turn to and trust. Now together as one family we are looking forward to an even brighter future,” said Roland Rott, President and CEO of GE Healthcare Ultrasound. “We have been on a journey to change the standard of care for surgery by making it possible for surgeons to make critical decisions in the operating room using real-time advanced visualization, allowing for better care, faster surgeries and reduced complications. Together with GE this journey will continue, and we can look forward to making a greater impact in healthcare around the world,” added Brooks West, President and CEO of BK Medical.
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Algorithm Allows Real-Time Image Reconstruction Combining Optical and MRI Data to Improve Breast Cancer Detection
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esearchers have developed a new image reconstruction approach that could contribute to better breast cancer detection. The deep learning algorithm developed by a research team from Dartmouth College (Hanover, NH, USA) overcomes a major hurdle in multi-modality imaging by allowing images to be recovered in real time. The new algorithm, known as Z-Net, works with an imaging platform that combines optical spectral information with contrast-free magnetic resonance imaging (MRI) to improve detection of breast cancer. The new algorithm can distinguish between malignant and benign tumors using MRI-guided near infrared spectral tomography (NIRST) imaging data from patient breast exams. Today, dynamic contrast-enhanced (DCE) MRI is recognized as the most sensitive breast cancer detection method. However, DCE MRI requires intravenous injection of a contrast agent and has a substantial false positive rate. Although non-contrast MRI-guided NIRST offers an alternative that doesn’t require contrast injection or ionizing radiation, reconstructing the combined images requires complicated light propagation models as well as time consuming MRI image analysis. The researchers used deep learning to make the image reconstruction process faster. Deep learning is a machine learning approach that creates connections among pieces of information in a way that is similar to how human brains operate, allowing the researchers to train their algorithm to recognize patterns and complex relationships. After training the algorithm, the researchers used simulated data to confirm that the quality of the reconstructed images was not degraded by eliminating diffuse light propagation modeling or by not segmenting MRI images. They then applied the new algorithm prospectively to MRI-guided NIRST data collected from two breast imaging exams – one leading to a biopsy-confirmed cancer diagnosis, the other resulting in a benign abnormality. The new algorithm generated images that could tell the difference between the malignant and benign cases. The researchers are now working to adapt the new image reconstruction method to work with 3D data and plan to test it in a larger clinical trial in the near future. “The near infrared spectral tomography (NIRST) and MRI imaging platform we developed has shown promise, but the time and effort involved in image reconstruction has prevented it from being translated into the day-to-day clinical workflow,” said Keith Paulsen, who led the research team. “Thus, we designed a deep-learning algorithm that incorporates anatomical image data from MRI to guide NIRST image forma-
tion without requiring complex modeling of light propagation in tissue.” “Z-Net could allow NIRST to become an efficient and effective add-on to non-contrast MRI for breast cancer screening and diagnosis because it allows MRI-guided NIRST images to be recovered in nearly real time,” added Paulsen. “It can also be readily adapted for use with other cancers and diseases for which multi-modality imaging data are available.” “The Z-Net algorithm reduces the time needed to generate a new image to a few seconds,” said Jinchao Feng, the study’s lead author. “Moreover, the machine learning network we developed can be trained with data generated by computer simulations rather than needing images from actual patient exams, which take a long time to collect and process into training information.”
AI Solution for Automating MRI Workflow at Point-of-Care
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ealthcare providers are experiencing continued pressure to increase diagnostic imaging supply while healthcare professionals in radiology consequently experience burnout at an alarming rate. Artificial Intelligence is next gen technology enabling a future, where radiology can provide more high-quality imaging with limited resources, simplified procedures through a high degree of automation. Siemens Healthineers (Erlangen, Germany; www.siemenshealthineers.com) has entered into a partnership with Cerebriu (Copenhagen, Denmark) to integrate the company’s patented Smart Protocol for Brain MRI-workflow automation software with its own MRI Cont’d on page 11 HospiMedica International February-March/2022
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Cont’d from cover
Medical Imaging
Hybrid PET/MRI Aids Breast Cancer Diagnosis
an in-depth analysis of cancer to select and guide appropriate treatment. Both, positron emission tomography (PET) and magnetic resonance imaging (MRI) can provide molecular and functional information that may be of vital importance to tailoring a patient’s therapy. However, current wholebody PET/MRI systems lack the necessary sensitivity and resolution for this task. Now, HYPMED, a consortium of 10 partner organizations from Europe that includes major universities, research institutes, clinics as well as major industry and small-to-medium-sized enterprises, is developing a hybrid system of the two medical imaging modalities (MRI and PET) for improved diagnosis of breast cancer and personalized therapy control. The HYPMED project, coordinated by the European Institute for Biomedical imaging (EIBIR, Vienna, Austria), aims to develop a radiofrequency coil that can be connected to any regular clinical MR scanner and transform the device into a high-resolution PET/MRI hybrid system, which can be used to identify even the smallest breast cancer tumors and better characterize the cancer, as well as its response to therapy. Patients will also benefit as the radiation dose of this new technology will, in contrast to other PET-MRI examinations, be comparable to a regular digital mammogram. To achieve this, the HYPMED research team will integrate a fully digital MRI-transparent PET detector into a novel multichannel PET transparent MRI surface coil. The PET-RF insert will allow vastly improved imaging of breast cancer with high resolution and ultra-high sensitivity PET, combined with a high level of structural and functional MRI. It will also facilitate minimally invasive MRI and PET-guided targeted biopsy. With HYPMED’s PET-RF insert, any regular clinical MRI scan could, upon demand, be turned into a hybrid PET system. The project will also evaluate the impact of this technology on breast cancer diagnosis, prediction, and monitoring/assessment of treatment response through a carefully designed clinical study that employs established
and novel PET tracers in 250 patients. Imaging data will be correlated with established and novel molecular biomarkers and the results will be compared to those obtained from whole-body PET/MRI and PET/CT. A multidisciplinary consortium of clinical scientists, three SMEs and an industry partner will pave the way for the commercialization of HYPMED products for advanced clinical decision making in cancer patients. Once HYPMED is successful, the project’s partners aim to expand this innovation to other medical applications such as prostate cancer or cardiac hybrid imaging, and introduce a paradigm shift in the field of PET/MR hybrid imaging as a whole. Image: Digital hybrid breast PET/MRI for enhanced diagnosis of breast cancer (Photo courtesy of HYPMED)
AI Solution for Automating MRI Workflow at Point-of-Care
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machines. The application is planned to be incorporated into the Open Workflow interface, which will allow solutions to be seamlessly integrated directly into the MRI examination workflow. Smart Protocol for Brain is designed to perform inprocess detection and protocol automation during image acquisition, providing personalized diagnostic imaging ensuring the right data for differential diagnosis. With Cerebriu enabled MRI machines, Siemens can provide radiology departments with clinically intelligent scanners that support the technologist with real-time adaptation of scanning protocols during acquisition without interrupting the radiologists, providing the radiologist with the right data at the right time, increasing patient throughput and comfort at the point of imaging. This integration is under development and not currently available for clinical use. ‘We are excited and proud to become the first AI technology company for MR Brain workflow automation Siemens Healthineers has entrusted to integrate into the Open Workflow interface,” said Robert Lauritzen, Chief Executive Officer at Cerebriu. “We automate radiology workflows to increase accessibility and improve quality of care, carefully balancing increased throughput with sustainable workloads to help tackle the increasing demand for neuroimaging,” said Akshay Pai, Chief Technology Officer. ‘’This partnership demonstrates a powerful synergy between innovators and visionary OEMs, together enabling healthcare providers to improve care at the point of imaging.’’ Image: Brain MRI protocol optimization at the point of imaging (Photo courtesy of Cerebriu)
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Wearable Magnetic Metamaterial Device Can Improve MRI Scans
newly designed wearable magnetic metamaterial could help make MRI scans crisper, faster, and cheaper. The gadget built by scientists at Boston University (Boston, MA, USA; www. bu.edu) is made of plastic and copper wire is a technological breakthrough with the potential to revolutionize medical imaging. Despite its playful look, the device is actually a metamaterial, packing in a ton of physics, engineering, and mathematical know-how. The scientists are experts in metamaterials, a type of engineered structure created from small unit cells that might be unspectacular alone, but when grouped together in a precise way, get new superpowers not found in nature. Metamaterials, for instance, can bend, absorb, or manipulate waves - such as electromagnetic waves, sound waves, or radio waves. Each unit cell, also called a resonator, is typically arranged in a repeating pattern in rows and columns; they can be designed in different sizes and shapes, and placed at different orientations, depending on
which waves they’re designed to influence. Metamaterials can have many novel functions. The scientists had earlier designed an acoustic metamaterial that blocks sound without stopping airflow (imagine quieter jet engines and air conditioners) and a magnetic metamaterial that can improve the quality of magnetic resonance imaging (MRI) machines used for medical diagnosis. Now, the team have taken their work a step further with the wearable metamaterial. The dome-shaped device, which fits over a person’s head and can be worn during a brain scan, boosts MRI performance, creating crisper images that can be captured at twice the normal speed. The helmet is fashioned from a series of magnetic metamaterial resonators, which are made from 3D-printed plastic tubes wrapped in copper wiring, grouped on an array, and precisely arranged to channel the magnetic field of the MRI machine. Placing the magnetic metamaterial - in helmet form or as the originally designed flat array - near the part of the body to be scanned could make
MRIs less costly and more time efficient for doctors, radiologists, and patients - all while improving image quality. Eventually, the magnetic metamaterial has the potential to be used in conjunction with cheaper low-field MRI machines to make the technology more widely available, particularly in the developing world. Image: New magnetic metamaterial device (Photo courtesy of Boston University)
Mobile CT Scanner with Photon Counting Detector Improves Bedside Diagnostics
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he world of medical imaging is no longer just black and white. Photon counting is a next-generation computed tomography (CT) technology that sorts the different energies of X-rays after they have passed through the scan field. A single X-ray source paired with Photon Counting Detector (PCD) generates multiple sets of CT data acquired at the same time with configurable energy thresholds without any cross talk between images. PCD provides the ability to capture CT data in multiple energy bands leading to potentially more accurate visualization and segmentation of bone, blood clots, plaque, hemorrhage, and intracranial tumors. There is also potential with PCD to lower the dose requirements, and fundamentally
change the use of injected contrast. NeuroLogica Corp. (Danvers, MA, USA), the U.S. healthcare subsidiary of Samsung (Suwon-si, South Korea), has received 510(k) clearance for the addition of PCD technology to its state-of-theart OmniTom Elite. With this, NeuroLogica delivers the first FDA 510(k) cleared, single-source photon counting CT scanner with single detector on a mobile system. OmniTom Elite with PCD can generate spectral CT images at multiple energy levels. The OmniTom Elite has the ability to provide versatile, real-time mobile imaging to administer point-of-care CT to critical patients without the need to transport them to a separate imaging department. The mobile unit will decrease the
time it takes to diagnose and initiate treatment for these critical patients. In the near term, all current OmniTom users will have the opportunity to upgrade their scanners with PCD technology. “NeuroLogica is driven by innovation. Since the advent of the world’s first multi-slice mobile CT in 2004, we have always known that pointof-care imaging can improve patient outcomes and increase the likelihood of a better quality of life after a traumatic event,” said David Webster, Chief Operating Officer of NeuroLogica. “With the introduction of PCD technology to the OmniTom Elite platform, we look to expand the diagnostic possibilities of CT at the patient’s bedside.” HospiMedica International February-March/2022
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Medical Imaging
PET Imaging Enables Non-Invasive, Real-Time Monitoring of Inflammation
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newly developed radio-labeled molecule enables real-time imaging of innate immune activity and offers improved specificity to monitor inflammation across many potential clinical applications. Researchers at The University of Texas MD Anderson Cancer Center (Houston, TX, USA; www.mdanderson.org) have developed a new radio-labeled molecule capable of selectively reacting with certain high-energy radicals that are characteristic of innate immune activity, which may allow a non-invasive approach to monitor inflammation in real time by positron emission tomography (PET) imaging. The researchers have taken advantage of new chemistry techniques to synthesize 4-[18F] Fluoro-1-Naphthol ([18F]4FN) as a novel reporter of myeloperoxidase (MPO) activity - a key enzyme active in the innate immune response. The molecule may be able to pinpoint areas of inflammation in a variety of clinical settings, such as inflammatory diseases, infections and immunotherapy-related side effects. The innate immune response is the body’s first line of defense against invading pathogens. In contrast to the adaptive immune response, innate immunity is nonspecific and acts broadly against infections or foreign agents. Innate immunity is largely driven by myeloid cells, including neutrophils, macrophages and natural killer (NK) cells. Myeloperoxidase is a highly conserved feature of the innate immune response across myeloid cells. This proinflammatory enzyme is activated by hydrogen peroxide to produce a variety of high-energy radicals that are used to eliminate pathogens. The research team focused on MPO activity to develop a redox-tuned reporter specific to innate immune activity. Using newly developed chemistry techniques, the team was able to synthesize [18F]4FN as a labeled molecule to selectively bind nearby proteins and cells when [18F]4FN has been oxidized by MPO plus hydrogen peroxide, but not hydrogen peroxide alone. The researchers evaluated the potential uses of [18F]4FN as an in vivo PET imaging tool in several laboratory models of inflammation. The molecule was able to successfully highlight inflammation from acute toxic shock, arthritis and contact dermatitis, ailments known to be mediated by activation of innate immunity. In addition, their results suggest [18F]4FN is a more specific and robust reporter of inflammation than other clinically utilized PET imaging agents, such as fluorodeoxyglucose ([18F]FDG). The research team is in discussions with clinical collaborators to test specific applications of [18F]4FN. An initial study, now under Food and Drug Administration review for Investigational New Drug registration and Institutional Re-
view Board approval, will evaluate [18F]4FN as an early biomarker of immune-related adverse events in patients being treated with immune checkpoint inhibitors. “There has been a long-standing interest in imaging inflammation and redox in general, but most current approaches generate high levels of background noise from biological processes that generate lower-energy radicals,” said David Piwnica-Worms, M.D., Ph.D., chair of Cancer Systems Imaging. “Our molecule is tuned toward inflammation mediated by high-energy radicals, offering the potential to selectively monitor activation of innate immunity.” “We need to verify this PET imaging agent in clinical studies, but it certainly has the potential for broad applications that could benefit patients across all kinds of diseases and clinical scenarios,” Piwnica-Worms added. “A tool like this could be used to identify multi-focal hotspots of inflammation, allowing physicians to intervene before disease progression or to follow the resolution of symptoms during therapy.” Image: New molecule offers improved specificity to monitor inflammation (Photo courtesy of The University of Texas MD Anderson Cancer Center)
MRI May Halve Breast-Cancer Mortality Among Women Carrying Certain Genes
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dicted the volume of false-positive screening results and benign biopsies, per 1,000 women scanned, that would accompany the researchers’ recommendations for annual MRIs starting earlier. Those projections translate to about four false-positive screening results and one to two benign biopsies per woman over a 40-year screening span, according to the researchers. The team hopes their analysis will aid all organizations that issue guidance for medical oncologists and radiologists. “Screening guidelines have been difficult to develop for these women because there haven’t been clinical trials to inform when to start and how to screen,” said Dr. Kathryn Lowry, an assistant professor of radiology at the University of Washington School of Medicine. “For women with pathogenic variants in these genes, our modeling analysis predicted a lifetime risk of developing breast cancer at 21% to 40%, depending on the variant. We project that starting annual MRI screening at age 30 to 35, with annual mammography starting at age 40, will reduce cancer mortality for these populations of women by more than 50%.” “We also found that starting mammograms earlier than age 40 did not have a meaningful benefit but increased false-positive screens,” Lowry added.
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Machine Learning Model Flags Abnormal Brain Scans in Real-Time
new machine learning model can reduce reporting times for abnormal examinations by accurately flagging abnormalities at the time of imaging. Researchers at King’s College London (London, UK; www.kcl.ac.uk) have developed a deep learning framework based on convolutional neural networks to flag clinically relevant abnormalities at the time of imaging, in minimally processed, routine, hospital-grade axial T2-weighted head MRI scans. The work was motivated by delays in reporting of scans in hospitals. A growing national and international demand for MRI scans, alongside a shortage of radiologists, together have led to an increase in the time taken to report head MRI scans in recent years. Delays cause the knock-on effect that it takes longer for the correct treatment to be given to patients, and therefore poorer patient outcomes and inflated healthcare costs. In a simulation study, the researchers found that their model reduced the wait times for reports for patients with abnormalities by about two weeks from 28 days to 14 days and from 9 days to 5 days. The current
achievements are underpinned by a recent model which addresses one existing problem blocking overarching developments in the application of deep learning to imaging: the difficulty in obtaining large, clinically representative, accurately-labeled datasets. Whilst accessing large hospital datasets is achievable, the data are usually unlabelled. The deep learning framework based on convolutional neural networks used in the current study to flag clinically relevant abnormalities at the time of imaging, could not have been developed without this earlier work which allowed head MRI dataset labeling at scale. In the current study, another step forwards towards clinical translation is that the researchers use routine, hospital-grade axial T2-weighted head MRI scans which have undergone little processing before triage analysis. This means head MRI scans can be used in the form that they arrive from the scanner which both cuts down from minutes to seconds the time that would otherwise be spent processing the images, but also allows more abnormalities to be detected in other areas captured by the head MRI – such as diseases in the skull, and around the Cont’d on page 18
Blood Oxygenator Minimizes Need For Invasive Mechanical Ventilation
Cont’d from cover
Inspira Technologies’ (Ra’anana, Israel; www.inspira-technologies.com) ART system has been awarded the 2021 Europe Technology Innovation Leadership Award by Frost & Sullivan based on findings from its analysis of the European artificial respiratory market. Inspira is developing the ART system, a cost effective early extracorporeal respiratory support system with an intent to function as an “Artificial Lung” for deteriorating respiratory patients. The ART is designed to utilize a hemo-protective flow approach aimed at rebalancing oxygen saturation levels while patients are awake and breathing, potentially minimizing the patient’s need for mechanical ventilation. A variety of ART system features set it apart from ECMO. ECMO treatment requires two large cannulas (21-25 French) single lumen cannulas used to withdraw and return 5 to 7 liters of blood per minute. In comparison, the ART treatment is designed to use one dual-lumen cannula (16 to 21 French) for withdrawing and returning 1 to 1.5 liters of blood per minute. Moreover, ECMO is a high-flow device that cannot support low-flow treatment; the ART system optimizes the effectiveness profile of the low-flow extracorporeal treatment. The ART includes a proprietary disposable support cartridge with an oxygenator, tubes, and pump-head. The cartridge is a fully sterilized, closed system that incorporates an innovative auto-priming system that prevents air embolisms and minimizes the need for perfusionists who are necessary for ECMO operation. Patients are medically induced into a coma during ECMO treatment,
whereas the ART system aims to treat patients while they are awake and spontaneously breathing. There is no need for induced medical comas with the ART system, allowing patients to breathe spontaneously and communicate with their surroundings, thus reducing the risks and complications associated with MV. The company expects submission of the Class II 510(k) for its’ Extracorporeal Life Support system (ECLS) in H1-2023, followed by initial market penetration in the respiratory care industry. Furthermore, the company plans to file its novel treatment, the ART system, for de-novo or PMA to the US Food and Drug Administration (FDA) in H2-2023. “Inspira Technologies’ ART system differs significantly from extracorporeal membrane oxygenation (ECMO) in many areas, including its intent of use, patient population, system size, and potential risks for the patient,” noted Debarati Sengupta, Industrial Analyst at Frost & Sullivan. “Unlike standard ECMO treatment, the ART system allows for early intervention. Alternative treatments, such as invasive mechanical ventilation, can be applied alongside the ART system if a patient’s health continues to deteriorate. The ART system demonstrates the company’s excellence in innovation within the respiratory care industry.” “Inspira will potentially overcome the complicated setup associated with ECMO and other systems, resulting in an efficient and effective procedure that safeguards a patient’s health,” added Samantha Fisher, Best Practices Research Analyst for Frost & Sullivan. “The innovation of the ART system is that it overcomes the limitations of its predecessors to deliver a less-invasive respiratory support system.” HospiMedica International February-March/2022
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Advanced AI Systems Could Assist Anesthesiologists in the OR
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new deep learning algorithm trained to optimize doses of propofol to maintain unconsciousness during general anesthesia could augment patient monitoring. A new study by researchers at MIT (Cambridge, MA, USA; www.mit.edu) and Massachusetts General Hospital (Boston, MA, USA; www.massgeneral.org) suggests the day may be approaching when advanced artificial intelligence (AI) systems could assist anesthesiologists in the operating room. The team of neuroscientists, engineers and physicians has demonstrated a machine learning algorithm for continuously automating dosing of the anesthetic drug propofol. Using an application of deep reinforcement learning, in which the software’s neural networks simultaneously learned how its dosing choices maintain unconsciousness and how to critique the efficacy of its own actions, the algorithm outperformed more traditional software in sophisticated, physiology-based simulations of patients. It also closely matched the performance of real anesthesiologists when showing what it would do to maintain unconsciousness given recorded data from nine real surgeries. The algorithm’s advances increase the feasibility for computers to maintain patient unconsciousness with no more drug than is needed, thereby freeing up anesthesiologists for all the other responsibilities they have in the operating room, including making sure patients remain immobile, experience no pain, remain physiologically stable, and receive adequate oxygen. The algorithm’s potential to help optimize drug dosing could improve patient care, according to the researchers. The research team designed a machine learning approach that would not only learn how to dose propofol to maintain patient unconsciousness, but also how to do so in a way that would optimize the amount of drug administered. They accomplished this by endowing the software with two related neural networks: an “actor” with the responsibility to decide how much drug to dose at every given moment, and a “critic” whose job was to help the actor behave in a manner that maximizes “rewards” specified by the programmer. For instance, the researchers experimented with training the algorithm using three different rewards: one that penalized only overdosing, one that questioned providing any dose, and one that imposed no penalties. The most effective reward system turned out to be the “dose penalty” one in which the critic questioned every dose the actor gave, constantly chiding the actor to keep dosing to a necessary minimum to maintain unconsciousness. Without any
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dosing penalty the system sometimes dosed too much and with only an overdose penalty it sometimes gave too little. The “dose penalty” model learned more quickly and produced less error than the other value models and the traditional standard software, a “proportional integral derivative” controller. After training and testing the algorithm with simulations, the researchers put the “dose penalty” version to a more real-world test by feeding it patient consciousness data recorded from real cases in the operating room. The testing demonstrated both the strengths and limits of the algorithm. During most tests the algorithm’s dosing choices closely matched those of the attending anesthesiologists after unconsciousness had been induced and before it was no longer necessary. The algorithm, however, adjusted dosing as frequently as every five seconds while the anesthesiologists (who all had plenty of other things to do) typically did so only every 20-30 minutes.
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As the tests showed, the algorithm is not optimized for inducing unconsciousness in the first place, the researchers acknowledged. The software also doesn’t know of its own accord when surgery is over, but it’s a straightforward matter for the anesthesiologist to manage that process. One of the most important challenges any AI system is likely to continue to face is whether the data it is being fed about patient unconsciousness is perfectly accurate. Another active area that the researchers are looking into is improving the interpretation of data sources, such as brain wave signals, to improve the quality of patient monitoring data under anesthesia. “Anesthesiologists have to simultaneously monitor numerous aspects of a patient’s physiological state, and so it makes sense to automate those aspects of patient care that we understand well,” said Gabe Schamberg, a former MIT postdoc who is also the study’s corresponding author.
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INCUBATOR
INFUSION PUMP
ICU VENTILATOR
The Giraffe Incubator Carestation combines innovative technology with exceptional thermal performance to create a state-of-the-art neonatal environment that promotes natural, peaceful healing.
The P600 infusion pump features a 4.2-inch high definition LCD color screen along with double infusion mode option and display (drip rate and volumetric). It performs real-time self check during startup and infusion process.
The elisa 800 ICU ventilator features a unique tandem sensor system that makes it suitable for a live weight range from 300 grams to 400 kilograms, and offers a variety of ventilation modes, maneuvers and weaning tools.
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Avoiding Heart Valve Replacement Surgery
Many heart patients implanted with such valves are currently forced to replace them ten years later due to calcification of valve tissue. The researchers have now been able to show that, by genetically engineering the biological component in the valve, it was possible to avoid immunological attack and calcification risk, thereby offering next-generation durable bioprosthetic heart valves. In the study, an international team of researchers led by those at Tel Aviv University (Tel Aviv, Israel), investigated close to 1700 patients with ~5000 blood samples covering almost 15 years since implantation. According to the researchers, patients can be implanted with either a mechanical heart valve that last long but requires daily administration of anticoagulants that can lead to life-threatening hemorrhages, or bioprosthetic heart valves (made from bovine, porcine or equine tissue) allowing patients to live a reasonably normal life, but those are commonly destroyed after a decade requiring replacement. “Since bioprosthetic heart valves are made of animal tissues, we hypothesized they contain foreign non-human sugars (Neu5Gc and alpha-Gal) that are attacked by the human immune system, which then mediate the calcification that lead to structural valve deterioration. Indeed, in our research we proved that this was the reason and even suggested an implementable solution,” said Dr. Vered Padler-Karavani from the Shmunis School of Biomedicine and Cancer Research at Tel Aviv University who led the study. “We discovered that all bioprosthetic heart valve patients developed an immune response against the foreign sugars in the valves. We could clearly see an increase in antibody responses against these sugars in implanted patients, as early as
one month after implantation, some lasting even two years later. We also found that some of the patients showed signs of calcification as early as two years post implantation.” The researchers also showed that the foreign sugars and the antibodies attacking them were found on calcified bioprosthetic heart valves explanted from patients some 10 years after implantation. Additionally, the dietary non-human sugar Neu5Gc and the antibodies against it were also found on explanted calcified native valves (the original malfunctioning human valves that needed to be replaced with a bioprosthesis). Since this sugar cannot be produced in the human body, it most likely accumulates on these valves from diet rich in red meat and dairy products where it is abundant. Therefore, it is possible that red meat diet mediates the initial need for valve replacement. The researchers also confirmed in a human-like animal model that antibodies against the foreign sugars indeed mediate calcification of tissues used for production of bioprosthetic heart valves. Furthermore, the option to employ genetic engineering to resolve the problem was examined. For this purpose, the researchers created genetically modified porcine (pigs) that do not express the sugars foreign to humans. The researchers found that in a human-like animal model that engineered tissue lacking the foreign sugars significantly had reduced calcification even in the presence of antibodies against the sugars and can therefore increase the durability of bioprosthetic heart valves made of such tissues. “This study marks breakthrough technology in the field of bioprosthetic heart valves and provides deep understanding of the mechanisms leading to structural valve deteriora-
tion. These findings can lead to a dramatic improvement in the quality of life of many heart patients. Now it would be interesting to study whether vegetarians or people who consume only small amounts of red meat and dairy have lower probability of heart valve calcification, and if this could perhaps be associated with low levels of antibodies against these foreign sugars. In the future it may also be possible to devise a modified diet to reduce the risk or to actually produce biological valves from the tissues of engineered animals that do not contain the sugars at all,” added Dr. Padler-Karavani. HospiMedica International February-March/2022
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Normothermic Perfusion System Preserves Donated Livers
fully automated mechanical perfusion system sustains donor livers destined for transplantation in a functioning state for up to 12 hours. The OrganOx (Oxford, United Kingdom; www.organox.com) metra is a normothermic (37°C) machine perfusion system that mimics the environment of the human body, supplying warm, oxygenated blood and nutrients to the donor liver. By continuously perfusing the liver at near physiological pressures and flows, metra allows it to remain functional, producing bile, metabolizing glucose, and maintaining pH. The metra system also measures and controls blood gases in the perfusate without user intervention, thus allowing objective assessment of organ performance prior to transplant. The system includes a simple three-button panel that controls flows, pressures, temperature, and blood gases, providing optimal perfusion conditions; an oxygenator that concentrates Oxygen (O2) from ambient air; an on-board heater to warm the blood; a centrifugal pump to draw blood from the liver; a soft-shell reservoir of warm, oxygenated blood, supplied to the liver under near-physiological pressure; and an automatic perfusion system that deliver medications and nutrients, minimizing operator hands-on time. “Through developing the metra, OrganOx has enabled transplant teams to objectively assess the function of a donor liver before a transplant, something which is impossible with ice box storage,” said Craig Marshall, CEO of OrganOx. “This is particularly important when a donor liver is identified as ‘marginal’, when there is uncertainty as to whether it will function following transplant. With our device we aim to make more livers available for transplantation to ensure that more patients can benefit from this life saving procedure.” The cornerstone of organ preservation has long been cold ischemic storage. Although this method is intended to reduce the extent of organ damage during transport, significant deterioration of the donated organ still occurs; the longer the organ is kept on ice, the greater the damage.
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Inversion Therapy Relieves Symptomatic Sciatica Pain
nversion tables can alleviate pain and symptoms in sciatica patients so that they may avoid surgery altogether, according to a new study. Researchers at Newcastle University (United Kingdom; www. newcastle.ac.uk), the Royal Victoria Infirmary (Newcastle upon Tyne; UK; www.newcastle-hospitals.nhs.uk), and other institutions conducted a study that compared surgery rates following inversion therapy in 85 participants with sciatica and lumbar disc disease, who acted as their own control for the symptomatic part of the study. Inversion therapy was provided via a Teeter (Bonney Lake, WA, USA; www.teeter.com) inversion table. The resulted showed that inversion therapy relieved pain symptoms compared with pre-treatment status, on a visual analog scale (VAS) score (by 74%), and on the Roland Morris and the Oswestry Disease indices (by 69% and 75%, respectively); 39% also reported that they eliminated the use of pain medication. In addition, two year surgery rate in the inversion participants in the registry (21%) was significantly lower than in the control group (39% at two years, and 43% at four years). The study was published in November 2021 issue of the Journal of Physical Therapy Science. “The forces that gravity exerts during inversion in patients with lumbar disc protrusions relieved their symptoms and avoided the need for surgery,” concluded lead author Alexander Mendelow, MD, of Newcastle University, and colleagues. “Also, in the inverted patients, their symptoms were significantly less severe than they were before the inversion therapy. Our study makes a strong case for setting up a large prospective randomized controlled trial of inversion therapy for these patients.” Teeter offers three models of inversion tables for people living with back pain due to sciatica, facet syndrome, and muscle spasms, among other conditions. The table allows a person to hang upside down while resting their back, releasing spinal compression, relieving disk and joint pain, as well as reducing the intensity of back spasms.
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Moreover, the cold storage technique does not enable any resuscitative or assessment while the organ is being transported from donor to recipient. It is estimated that 60-65% of organs cannot ultimately be used for transplantation due to the limitations of cold storage. Image: Administering Iron to dialysis patients can reduce incidental heart attacks
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The 6000E pneumatic resuscitator is pneumatic and gas controlled with a built-in anti-backflow valve and offers multiple oxygen concentration options along with adjustable respiratory rate and tidal volume.
The Atom Transcapsule V-707 is a closed-type transport incubator for neonatal and premature infants intended to transport low birth weight infants and neonates. It is ideal for hospitals, delivery suites, NICU, and transport.
The iM 15 Multi-Parameter Patient Monitor features a 15 inch (38 cm) high resolution color TFT display with LED backlight and an optional full touchscreen for easy operation.
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Capsule Surveillance Solution Identifies Deteriorating Patient Conditions and Critical Events for Early Intervention
arly identification of deteriorating patient conditions can help hospitals avoid complications and escalations, contributing to lower cost of care, while the ability of clinical staff to remotely monitor large numbers of patients and focus resources where needed can help mitigate the shortage of experienced clinicians. Royal Philips (Amsterdam, the Netherlands) will soon launch the latest Philips Capsule Surveillance solution that allows clinicians to see patient data and patient monitor settings and alarms from multiple device types without needing to enter the patient’s room. When caring for infectious patients, this can help reduce the risk to clinical staff. Capable of utilizing streaming data from virtually any connected medical device, the solution aggregates patient data, analyses it to generate actionable insights and alerts, and sends timely notifications to the patient’s caregivers so that they can intervene before deterioration progresses further. The latest Philips Capsule Surveillance solution which now includes expanded interoperability into hospitals’ existing mobile clinical communication and collaboration tools and electronic intensive care units (eICUs) and virtual care population health management systems, offering more visibility on live streaming data, waveforms, device alarms and contextual alerts. Philips Capsule Surveillance offers an enterprise-wide solution that complements eICU telehealth command center solutions, such as Philips eCareManager, by bringing together live-streaming patient data across multiple acuity settings, equipment brands and device types to show each patient’s immediate status. Built on the vendor-neutral Philips Capsule Medical Device Information Platform, which captures and normalizes streaming data from a network of connected devices, the Philips Capsule Surveillance software continuously analyzes patient data using patented technology to identify deteriorating conditions and critical events. The software applies a set of smart rules based on clinical parameters and current best-practice guidelines that can be tailored to an individual hospital’s protocols for specific morbidities. The company has received 510(k) market clearance from the U.S. Food & Drug Administration (FDA) for the latest Philips Capsule Surveillance solution, paving the way for its widespread deployment across healthcare systems in the US. “This FDA clearance of the latest release of clinical surveillance solution enables more integrated viewing options within EMR and HIT tools through the secure web-based user interface. The updated intended use provides flexible deployment configurations that Philips Capsule can offer to hospitals and health systems in the USA,” said Elad Benjamin, general manager of Clinical Data Services at Philips. “Properly implemented clinical surveillance has the potential to significantly improve patient outcomes by helping to avoid deterioration, while also improving the care team experience via clinical decision support and minimizing the burden of false and clinically unactionable alarms.”
Image: A nurse reviews patient data via Philips Capsule Surveillance (Photo courtesy of Royal Philips)
Machine Learning Model Flags Abnormal Brain Scans in Real-Time Cont’d from page 14
eyes and nose. The speed and coverage of the abnormality detection system enables real-time applications. “Our model can reduce reporting times for abnormal examinations by accurately flagging abnormalities at the time of imaging, thereby allowing radiology departments to priorities limited resources into reporting these scans first. This would expedite intervention by the referring clinical team,” said Dr. David Wood, Research Associate, School of Biomedical Engineering & Imaging Sciences. “Having previously built and validated a labeled head MRI dataset using cutting edge machine learning methodology through a team of data scientists and hospital radiologists, the same team have now built and validated a new machine learning model that can triage head MRI scans so the abnormal scans can be at the front of the queue for reporting. The potential benefit to patients and healthcare systems is enormous,” added Dr. Thomas Booth, Senior Lecturer in Neuroimaging at the School of Biomedical Engineering & Imaging Sciences and Consultant Diagnostic and Interventional Neuroradiologist at King’s College Hospital. HospiMedica International February-March/2022
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Risk Calculator Prevents Delayed Discharges in Hospitals
novel prediction model that identifies patients occupying emergency departments (EDs) longer than needed could significantly reduce overcrowding, claims a new study. Developed by researcher at University Hospitals of North Midlands (UHNM; Stoke-on-Trent, United Kingdom) and Staffordshire University (United Kingdom), the eight-variable predictive tool calculates the probability of a patient experiencing a delayed discharge already at admission. The researchers first interrogated administrative and clinical data to identify patient factors related to delayed transfer of care (DTOC) on discharge, and developed a predictive model for identifying such patients. Three-years of data on 92,444 admissions were used to develop the eight-variable predictive model, and 39,877 admissions were used to validate it. The variables (age, gender, ethnicity, national early warning score (NEWS), Glasgow admission prediction score, Index of Multiple Deprivation (IMD) decile, arrival by ambulance, and admission within the last year) exhibited a 79% sensitivity, 69% specificity, and 70% overall accuracy for identifying patients who will experience DTOC. The study was published on September 29, 2021, in the International Journal for Quality in Health Care. “We based our model on data routinely collected in all hospitals, which means it has the potential to be adopted across the NHS. This problem is not going to vanish, and in the wake of COVID-19 it is more important than ever to find solutions,” said senior author MD Asaduzzaman, PhD, of the Staffordshire University department of engineering. “We must develop a well-designed patient care pathway model for vulnerable patients, incorporating all stakeholders including acute care hospitals and social care centers alongside local governments.” A DTOC occurs when an adult inpatient is medically ready to go home but is still occupying a hospital bed. Delays to discharge can have serious implications such as mortality, infections, depression, and reductions in patients’ mobility and their ability to undertake daily activities. In addition, there is a
Modular System Coordinates Cardiac Rhythm Management
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novel combination of cardiac rhythm management (CRM) devices can deliver both bradycardia pacing support and antitachycardia pacing (ATP). The Boston Scientific (Natick, MA, USA; www.bostonscien tific.com) mCRM Modular Therapy System consists of two CRM devices designed to work together to coordinate therapy - the EMBLEM MRI subcutaneous implantable defibrillator (S-ICD) system, which is a proven treatment option for the prevention of sudden cardiac death (SCD), and the investigational EMPOWER modular pacing system (MPS), a leadless implantable pacemaker designed to terminate episodes of fast, abnormal heart rates. The EMBLEM S-ICD System uses a subcutaneous electrode to effectively sense, discriminate, and convert ventricular fibrillation (VF) and ventricular tachycardia (VT) for arrhythmia treatment. A second feature, the atrial fibrillation (AF) monitor, helps physicians make more informed treatment decisions for their patients. The S-ICD System is labeled safe for use in a MRI setting when conditions of use are met. The EMPOWER MPS, currently under investigational use, is designed to complement the S-ICD System. “Since the EMPOWER MPS device can be delivered percutaneously via a minimally invasive approach without the use of leads, the mCRM System could preserve many of the benefits of the S-ICD system while offering an option for patients who subsequently develop a pacing requirement,” said Kenneth Stein, MD, senior vice president and chief medical officer of rhythm management and global health policy at Boston Scientific. “The components of the system are designed to work in concert with each other, giving physicians the ability to provide personalized patient care today while keeping options open in the future.” ATP has long been recognized as a way to pace-terminate certain types of arrhythmias, particularly slow monomorphic ventricular tachycardia (VT) involving a reentry circuit, by delivering a short pacing stimuli to the heart at a rate faster than the tachycardia. The idea is take an advantage of the gap between successive activations when the myocardium can receive an activation wavefront that collides with one of the preexisting tachycardia in order to terminate it.
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significant secondary effect on patients waiting for admission from emergency portals to the wards, as these “blocked beds” cause a bottleneck effect, which results in increased mortality, poor patient outcomes, and significantly higher consumption of hospital resources. Image: Delayed patient discharge can lead to a ripple effect of overcrowding in emergency departments (Photo courtesy of Getty Images)
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SURGICAL MONITOR
SURGICAL PANEL
DIGITAL SURGICAL MICROSCOPE
The PAX-324 surgical monitor is designed to deliver medical images of optimal quality and supports full HD resolution of 1920x1200 @ 60 Hz. Equipped with DICOM Part 14 GSDF compliance 14-bit LUT processing grayscale.
The Surgical Panel SP2-24-554K with two integrated monitors as well as build-in IT and video management components is a digital image viewing system, designed for use in the operating room.
The Aesculap Aeos is a digital surgical microscope platform with a superior depth of field and illumination and wider field of view. Its lookover 3D heads-up surgery allows working in an ergonomically comfortable posture.
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HD Fluorescence Endoscopic Imaging System Enhances Real-Time Visualization of Tissue Perfusion
O
ptoMedic Technologies, Inc.’s (Guangdong, China; www.optomedic.com) 2100 Series HD FloNavi Fluorescence Endoscopic Imaging System is leading the traditional endoscopic system industry into the new era of functional endoscopic system. The 2100 Series HD FloNavi enhances visualization of tissue perfusion in real-time and enable users to switch between white light mode, standard FL mode, color scale FL mode, and multi-display mode at any time during surgery. It allows real-time lymphatic system tracking, tissue perfusion observation, and accurate tumor boundary mapping, providing multiple minimally invasive applications. The Precision Fluorescence Imaging System offers brilliant high-definition imaging using innovative 4CMOS technology with resolution of 1920x1080P. Other key features include innovative coating treatment and premium optics, along with a switch mode by pressing the camera button, which is extremely convenient to use.
Image: HD Fluorescence Endoscopic Imaging System (Photo courtesy of OptoMedic Technologies, Inc.)
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Self-Learning AI-Based Algorithm Reads Electrocardiograms to Spot Unseen Signs of Heart Failure
new self-learning algorithm can detect blood pumping problems by reading electrocardiograms (also known as ECGs or EKGs) to predict whether a patient was experiencing heart failure. The special artificial intelligence (AI)-based computer algorithm created by researchers at Mount Sinai (New York, NY, USA) was able to learn how to identify subtle changes in electrocardiograms (also known as ECGs or EKGs) to predict whether a patient was experiencing heart failure. Heart failure, or congestive heart failure, occurs when the heart pumps less blood than the body normally needs. For years, doctors have relied heavily on an imaging technique called an echocardiogram to assess whether a patient may be experiencing heart failure. While helpful, echocardiograms can be labor-intensive procedures that are only offered at select hospitals. However, recent breakthroughs in AI suggest that electrocardiograms - a widely used electrical recording device - could be a fast and readily available alternative in these cases. For instance,
many studies have shown how a “deep-learning” algorithm can detect weakness in the heart’s left ventricle, which pushes freshly oxygenated blood out to the rest of the body. In this study, the researchers described the development of an algorithm that not only assessed the strength of the left ventricle but also the right ventricle, which takes deoxygenated blood streaming in from the body and pumps it to the lungs. Typically, an electrocardiogram involves a two-step process. Wire leads are taped to different parts of a patient’s chest and within minutes a specially designed, portable machine prints out a series of squiggly lines, or waveforms, representing the heart’s electrical activity. These machines can be found in most hospitals and ambulances and require minimal training to operate. For this study, the researchers programmed a computer to read patient electrocardiograms along with data extracted from written reports summarizing the results of corresponding echocardiograms taken from the same patients. In this situation, the written reports acted as a standard set of data
for the computer to compare with the electrocardiogram data and learn how to spot weaker hearts. Natural language processing programs helped the computer extract data from the written reports. Meanwhile, special neural networks capable of discovering patterns in images were incorporated to help the algorithm learn to recognize pumping strengths. The computer then read more than 700,000 electrocardiograms and echocardiogram reports obtained from 150,000 Mount Sinai Health System patients from 2003 to 2020. Data from four hospitals was used to train the computer, whereas data from a fifth one was used to test how the algorithm would perform in a different experimental setting. Initial results suggested that the algorithm was effective at predicting which patients would have either healthy or very weak left ventricles. Here strength was defined by left ventricle ejection fraction, an estimate of how much fluid the ventricle pumps out with each beat as observed Cont’d on page 22
HospiMedica International February-March/2022
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Bone Graft Delivery System Resolves Challenges of Spinal Surgery
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next generation minimally invasive bone graft delivery system utilizes a pre-loaded bone graft cannula and a streamlined trigger-based system as a bone graft delivery solution that is optimized for the unique challenges of minimally invasive surgery. Synergy Biomedical, LLC (Wayne, PA, USA; www.synergybiomed ical.com) has launched the BIOSPHERE MIS II system which permits strategic and controlled placement of the company’s regarded next-generation synthetic bone graft product (BIOSPHERE PUTTY) in open, mini-open, and percutaneous minimally invasive settings. BIOSPHERE MIS II PUTTY utilizes patented bioactive glass spheres that have been shown in vivo to result in faster and more robust bone formation. The product provides surgeons with a moldable bone graft material that has one of the highest bioactive glass contents on the market. The BIOSPHERE MIS II bone graft delivery system consists of several new innovative features such as a new hand-held dispenser, an upgraded trigger configuration, and a graft delivery cannula, pre-loaded with BIOSPHERE PUTTY. Design advances with BIOSPHERE MIS II include a new locking technology that provides audible and tactile confirmation for a secure locked connection between the cannula and dispenser. A low-profile system maximizes the surgeons’ view during graft delivery around implanted hardware and difficult to access anatomic locations. An enhanced trigger design provides surgeons with full control of BIOSPHERE PUTTY delivery volume and location. The BIOSPHERE MIS II system is a uniquely designed two-piece assembly specifically engineered for increasing efficiency in the OR. “BIOSPHERE MIS II is a low-profile graft delivery system that allows me to place graft in difficult to access locations without obstructing my view. My favorite feature is being able to control the amount of graft that is delivered by simply deploying the trigger handle,” stated Dr. Barcohana, M.D., a spine surgeon at the Southern California Orthopedic Institute in alliance with UCLA Health).
Bioelectronic Sutures for Deep Surgical Wounds
Cont’d from cover
signals; a battery-free electronic capacitive sensor; and an external wireless reader used to communicate with the suture. During stitching of the wound, the insulating section of the suture is threaded through the electronic module and secured by applying medical silicone to the electrical contacts. The entire surgical stitch functions as a radio-frequency identification (RFID) tag that can be read by an external reader. The smart sutures can be read up to a depth of 50 mm, depending on the length of stitches involved, and are also able to alert clinicians if they are broken or unraveled, for example by dehiscence of the wound. Similar to existing sutures, clips, and staples, the smart sutures can be removed post-operatively via a minimally invasive procedure when risk of complications has passed. The study was published in the December 2021 issue of Nature Biomedical Engineering. “Currently, post-operative complications are often not detected until the patient experiences systemic symptoms like pain, fever, or a high heart rate,” said senior author John Ho, PhD, of the NUS department of Electrical and Computer Engineering. “These smart sutures can be used as an early alert tool to enable doctors to intervene before the complication becomes life-threatening, which can lead to lower rates of re-operation, faster recovery, and improved patient outcomes.”
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Image: BIOSPHERE MIS II system increases OR efficiency (Photo courtesy of Synergy Biomedical, LLC) RS TO LY IBU PP TR TO A S I D TED I INV
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SURGICAL ASPIRATOR
OPERATING TABLE
ENDOSCOPIC IMAGING SYSTEM
The MEDAP TWISTA SP 1070 is a powerful surgical aspirator specially designed for reliable continuous operation in the operating room. Large amounts of septic fluid, blood and serous fluids can be suctioned quickly and quietly.
The Dr. Max 5800 Series operating table features a built-in kidney bridge that provides operation outside of sterile field on the left or right side of the head-end to avoid interference of surgical procedures and contamination.
The 2100 Series HD FloNavi Fluorescence Endoscopic Imaging System enhances visualization of tissue perfusion in real-time. It allows real-time lymphatic system tracking, tissue perfusion observation, and accurate tumor boundary mapping.
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Augmented Reality Navigation Streamlines Surgical Workflow
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n advanced surgical planning and screw placement system combines real-time imaging and augmented reality (AR) navigation. The Royal Philips (Philips; Amsterdam, The Netherlands; www.philips.com) ClarifEye system is designed to merge both 2D and 3D visualizations at low X-ray dose with 3D AR navigation into one system. This enables surgeons to define and navigate along the critical pathway using real-time guidance for precise device and screw placement in open and minimally invasive spine procedures. ClarifEye is intended to be used in conjunction with the Azurion Hybrid Operating Room (OR), into which it fully integrates. ClarifEye uses four high-resolution video cameras located in the C-arm and flat panel detector (FPD) in order to automatically detect non-invasive patient markers placed to augment the surgical field. The live video images provided by the cameras are overlaid onto the 3D cone-beam computerized tomography (CBCT) scan used for pre-surgical planning. The system can then visualize the tip of the ClarifEye Nee-
dle as it is navigated along the planned path towards the spinal anatomy, and up to screw placement. “We’re excited that international access to ClarifEye is expanding, and more hospitals and patients will get to experience its benefits firsthand,” said Karim Boussebaa, general manager of image guided therapy systems at Royal Philips. “ClarifEye adds a new dimension in surgical precision for patients. It is a great example of how we’re innovating procedures and helping clinicians to deliver on the Quadruple Aim of better health outcomes, improved patient experience, staff satisfaction, and lower cost of care.” “Philips’ new technology enables us to perform less invasive procedures and produce better outcomes for patients with spine conditions,” said Ahmed Al Jahwari, MD, head of the department of orthopedics and spine surgery at the Armed Forces Hospital (Muscat, Oman). “Thanks to the high quality of the intraoperative cone beam CT imaging and the positioning flexibility of the ClarifEye system, we can ensure that implants are in place, which lowers post-operative CT scans to check implant
placements.” Many spine conditions have traditionally been ‘open surgery’, where surgeons would manually manipulate the patient’s spine to position implants and pedicle screws. As technology has advanced, there has been a shift to using minimally invasive techniques that minimize blood loss and soft tissue damage and consequently reducing postoperative pain. Intra-operative image guidance increases clinical accuracy and improves outcomes, with patients subject to fewer revision surgeries. Image: ClarifEye combines imaging and AR navigation into one system (Photo courtesy of Royal Philips)
Self-Learning AI-Based Algorithm Reads Electrocardiograms to Spot Unseen Signs of Heart Failure cont’d from page 20
on echocardiograms. Healthy hearts have an ejection fraction of 50% or greater while weak hearts have ones that are equal to or below 40%. The algorithm was 94% accurate at predicting which patients had a healthy ejection fraction and 87% accurate at predicting those who had an ejection fraction that was below 40%. However the algorithm was not as effective at predicting which patients would have slightly weakened hearts. In this case, the program was 73% accurate at predicting the patients who had an ejection fraction that was between 40% and 50%. Further results suggested that the algorithm also learned to detect right valve weaknesses from the electrocardiograms. In this case, weakness
was defined by more descriptive terms extracted from the echocardiogram reports. Here the algorithm was 84% accurate at predicting which patients had weak right valves. Finally, additional analysis suggested that the algorithm may be effective at detecting heart weakness in all patients, regardless of race and gender. “We showed that deep-learning algorithms can recognize blood pumping problems on both sides of the heart from ECG waveform data,” said Benjamin S. Glicksberg, PhD, Assistant Professor of Genetics and Genomic Sciences, a member of the Hasso Plattner Institute for Digital Health at Mount Sinai, and a senior author of the study published in the Journal of the American College of Cardiology: Cardiovascular Imaging. “Ordinarily, diagnosing
these type of heart conditions requires expensive and time-consuming procedures. We hope that this algorithm will enable quicker diagnosis of heart failure.” “This study represents an exciting step forward in finding information hidden within the ECG data which can lead to better screening and treatment paradigms using a relatively simple and widely available test,” said Girish N. Nadkarni, MD, MPH, CPH, Associate Professor of Medicine at the Icahn School of Medicine at Mount Sinai, Chief of the Division of Data-Driven and Digital Medicine (D3M), and a senior author of the study. “A potential advantage of this study is that it involved one of the largest collections of ECGs from one of the most diverse patient populations in the world.” HospiMedica International February-March/2022
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A
Nonablative Brain Surgery Treats Neurological Diseases
ow-intensity MR-guided focused ultrasound (MRgFUS), combined with intravenous microbubbles, can help deliver targeted neurotoxin therapy, according to a study. The new technique, called PING, was developed by researchers at the University of Virginia (UVA; Charlottesville, USA; www.virginia. edu), Stanford University (CA, USA; www.stanford.edu), and other institutions. It is designed to destroy neurons in the brain parenchyma by opening up the blood-brain barrier (BBB) in a transient and focal manner in order to deliver a systemically administered neurotoxin (quinolinic acid) that is well tolerated peripherally and otherwise impermeable to the BBB. In two research models of epilepsy in rats, the researchers found that PING can reduce or eliminate the seizures. Focal neuronal loss was observed in the targeted areas of BBB opening, including brain regions that are prime objectives for epilepsy surgery. Notably, they found that other structures in the area of neuronal loss, including axons of passage, glial cells, vasculature, and the ventricular wall, were spared with this procedure. The study was published on November 19, 2021, in the Journal of Neurosurgery. “This novel surgical strategy has the potential to supplant existing neurosurgical procedures used for the treatment of neurological disorders that don’t respond to medication. This unique approach eliminates the diseased brain cells, spares adjacent healthy cells, and achieves these outcomes without even having to cut into the scalp,” said lead author Kevin Lee, PhD, of the UVA Departments of Neuroscience and Neurosurgery and the Center for Brain Immunology and Glia (BIG). “Our hope is that PING strategy will become a key element in the next
A
generation of very precise, noninvasive, neurosurgical approaches to treat major neurological disorders.” The BBB is comprised of specialized endothelial cells that form the capillary microvasculature of the central nervous system (CNS), and is essential for brain function. It selectively prevents substances from entering the blood and brain, only allowing such essential molecules as amino acids, oxygen, glucose and water through. But on the other hand, it also poses the greatest impediment in the treatment of many CNS diseases because it commonly blocks entry of therapeutic compounds. Image: The ExAblate focused ultrasound system (Photo courtesy of InSightec)
Spinal Fixation System Increases Intraoperative Flexibility
novel spinal fixation system provides a low implant profile that allows screw placement through a midline cortical trajectory. The CoreLink (St. Louis, MO, USA; www.corelinksurgical.com) CentraFix Midline Fixation System is a posterior thoracolumbar pedicle screw platform designed for a medial-to-lateral midline approach. Known as cortical bone trajectory (CBT), the technique maximizes contact of the pedicle screw with cortical bone and is intended to reduce incision size, limit muscular and vascular injury, and improve initial fixation. The system also contains modular cobalt chrome tulip heads and titanium alloy screw shanks in various lengths and diameters, designed specifically to allow screw placement in denser cortical bone. The CentraFix low-profile, modular tulip heads are also designed to increase visualization in smaller incisions, minimize tissue disruption, and simplify distraction, all without compromising strength. The self-drilling, self-tapping, cortical screw threading provides easy screw starting in the intended trajectory, and allows for 360° motion with a 60° cone of angulation. The system includes 4.75mm and 5.5mm rod options, set screws designed to minimize tulip splay, and ergonomic and intuitive instrumentation to facilitate fast and efficient surgery. “With a unique heritage that combines old-world craftsmanship with state-of-the-art manufacturing, we collaborate with surgeons to develop and deliver effective surgical solutions and improve the lives of patients,” said Jay Bartling, CEO of CoreLink. “The CentraFix System provides unmatched intraoperative visualization and surgical flexibility for the midline approach. In-house development and manufacturing have allowed us to produce our most innovative fixation system to date.” Pedicle screw s provide a means of gripping a spinal segment. The screws themselves do not fixate the spinal segment, but act as firm anchor points that can then be connected with a rod. The screws are placed at two or three consecutive spine segments and then a short rod is used to connect the screws; this construct prevents motion at the segments that are being fused. After the bone graft grows, the
23
Surgical Techniques
HospiMedica International February-March/2022
screws and rods are no longer needed for stability and may be safely removed with a subsequent back surgery. However, most surgeons do not recommend removal unless the pedicle screws cause discomfort for the patient.
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Spinal Implant Matches Patient’s Bone Density and Quality for Personalized Spine Surgery
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new line of cervical cages for anterior cervical discectomy with fusion procedures are the first in the world to match a patient’s bone density and quality to a personalized implant, thus improving spinal surgery outcomes. Aurora Spine Corporation’s (Carlsbad, CA, USA) DEXA-C cervical interbody system is the first of its kind in the world based upon a patient’s bone density. Aurora’s patented DEXA technology creates a series of implants manufactured with varying densities to match a patient’s bone density and DEXA T-Score. DEXA-C cervical interbody system is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score, which indicates a patient’s bone density. By comparing and using a product that matches a patient’s bone density, the technology should promote quicker bone growth and employ superior fixation. According to recently published research article demonstrating the need for novel spinal implants, a confluence has emerged between the rising prevalence of degenerative spinal disease and osteoporosis with an increasingly aging population globally. Fusion of the anterior spinal column remains the mainstay surgical intervention for many spinal degenerative disorders. However, decreased vertebral bone mineral density (BMD), quantitatively measured by traditional DEXA scanners or portable, R.E.M.S. Technology (Radiofrequency Echographic Multi Spectrometry) based bone densitometry scanner, complicates treatment with surgical interbody fusion as weak underlying bone stock increases the risk of post-operative implant-related adverse events, including cage subsidence. There is a necessity for developing cages
with advanced structural designs that incorporate bioengineering and architectural principles to tailor the interbody fusion device directly to the patient’s BMD status. Specifically, lattice-designed cages that mimic the web-like structure of native cancellous bone have demonstrated excellent resistance to post-operative subsidence. Aurora Spine’s DEXA-C spinal interbody implant designed intentionally to simulate the lattice structure of human cancellous bone, with a similar modulus of elasticity, and specialized to match a patient’s bone status across the BMD continuum. The implant incorporates an open pore design where the degree of pore compactness directly corresponds to the patient’s DXA-defined BMD status, including patients with osteoporosis. “It’s a significant milestone for Aurora to announce the completion of the world’s first surgical implantations of the DEXA-C patient-bone-density matched interbody devices,” said Trent Northcutt, CEO and President at Aurora Spine. “The DEXA-C implants, a line of cervical cages for anterior cervical discectomy with fusion (ACDF) procedures, are the first of its kind in the world by offering an implant based upon a patient’s bone density. It is also the first color-coded implant on the marketplace and will help doctors match against the color-coding of a DEXA score.” “Aurora’s DEXA Technology includes X-ray readable Density Markers that can visually confirm if low, medium or high-density devices were implanted in a particular patient. We think that for the first time, patients worldwide will benefit when they are able to receive fusion implants that match their own bone,” added Laszlo Garamszegi, Chief Technology Officer of
Aurora Spine. “The DEXA-C implant from Aurora Spine ushers in a new era of personalized spine surgery. This customization prevents implant subsidence and accelerates fusion even in healthy individuals. This will expand access to spine surgery for older patients who were previously excluded by poor bone quality,” said Dr. Sebastian Koga, Neurosurgeon at Koga Neurosurgery. “These initial surgeries confirmed my belief about the support provided by the Echolight bone scanner before the operation, and the software generated instant report. Based on the report we can select the appropriate density implant from the DEXA-C range. For the first time we can use a hand-held ultrasound probe to scan a patient’s bone density and choose the best spinal implant matching to their bone quality. Aurora Spine has developed the DEXA family of implants which mimic the natural bone of patients with osteopenia and osteoporosis. Aurora’s DEXA Platform, supported by Echolight, is likely to have significant advantages by providing cervical fusion candidates with a one-stop shop for patient matched implants based on quick and accurate real-time bone quality analysis with immediately available accurate T-score reports minutes before surgery.” Image: DEXA Technology includes X-ray readable density markers (Photo courtesy of Aurora Spine Corporation) HospiMedica International February-March/2022
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I
ICU Medical Acquires Smiths Medical, Forges New Infusion Powerhouse
CU Medical Inc. (San Clemente, CA, USA) has completed its acquisition of Smiths Medical (Minneapolis, MN, USA) from Smiths Group plc., creating a new powerhouse in the field of infusion therapy. The Smiths Medical business includes syringe and ambulatory infusion devices, vascular access, and vital care products. The acquisition aims to support the expansion of ICU Medical’s infusion therapy product line and expand the portfolio into newer clinical care markets. When combined with ICU Medical’s existing business, the combined companies create a leading infusion therapy company with estimated projected combined
revenues of around USD 2.5 billion. ICU Medical has been increasing its global share of the infusion pump market for several years. Its acquisition of Hospira’s critical care business in 2017 enabled the company to gain a strong foothold in the large-volume infusion pump market, both in the US and internationally. ICU’s broader offerings in monitoring and oncology has also enabled the company to expand into wider clinical markets. Smiths Medical has a broader offering of solutions, ranging from infusion to patient monitoring and respiratory care. Analysts expect the combined ICU Medical and Smiths Medical business to expand its offeringo across clinical care markets beyond the infusion field.
J&J Medical Partners with Microsoft in Digital Surgery Solutions
T
he Johnson & Johnson Medical Device Group (J&J; New Brunswick, NJ, USA) will collaborate with Microsoft (Redmond, WA, USA) toward expanding J&J’s secure and compliant digital surgery product range. The Microsoft Cloud is expected to help J&J advance skills, improve workflow, and enhance surgical decision making toward improving customer experience as well as patient and economic outcomes. J&J’s medical technologies include next generation robotics, world-class instrumentation, advanced imaging and visualization, data and analytics, artificial intelligence, machine learning, and digital solutions. As part of the strategic partnership, Microsoft will serve as J&J’s preferred cloud provider for the company’s digital surgery solutions and help J&J build out its digital surgery platform and internet of things (IoT) device connectivity. By harnessing the power of the Microsoft
Cloud, including Azure, artificial intelligence (AI), and machine learning, Microsoft 365 and Dynamics 365, the companies expect to work together to improve patient outcomes through AI, machine learning and data insights; increasing J&J’s device connectivity, insights and intelligence using Azure IoT and Edge Computing technologies; and increasing the pace of digital innovation and transformation across the J&J digital surgery ecosystem using Azure capabilities and services. “Collaborating with Microsoft will help take our digital approach to the next level as we create a best-in-class, unified platform across our innovative surgical technologies,” said Larry Jones, Group CIO and Global VP, Medical Devices, J&J. “It brings together our collective expertise and is an exciting step towards creating a connected patient journey across the entire care continuum, before, during, and after a procedure.”
NeuroLogica to Adopt Boston Imaging Brand Name for DR and Ultrasound Business
N
euroLogica Corp., the U.S. healthcare subsidiary of Samsung (Suwon-si, South Korea), has announced that the company’s digital radiography and ultrasound (DR & ULS) business will operate under a new brand-name called Boston Imaging (Danvers, MA, USA). Boston Imaging will serve as the US headquarters for sales, marketing and distribution of all Samsung digital radiography and ultrasound products. “This is a momentous day for the company, as it will allow us even greater focus on our core expertise, providing the U.S. market with Digital
25
HospiMedica International February-March/2022
Radiography and Ultrasound Imaging devices with Samsung healthcare technology at the core,” said David Legg, Vice President, Ultrasound and Digital Radiography, Boston Imaging.” “Our new brand, Boston Imaging, reinforces the strength of our legacy and signals the potential of our future,” added Legg. “Our past advancements and achievements within the two modalities include the current introduction of innovative products such as the V8 Ultrasound system and artificial intelligence solutions, like Auto Lung Nodule Detection (ALND) tool, in Digital Radiography.”
Industry News
Explosive Growth Seen for Medical Virtual Reality Systems Worldwide
T
he global medical virtual reality (VR) in medical market was valued at USD 0.44 billion in 2020 and is expected to register a CAGR of 31.1% during the forecast period 2021-28 to reach nearly USD 4 billion in 2028, driven by the increasing use of VR in surgical training and patient treatment, rapid technological advancements in VR headsets, and growing application of VR in medical education. These are the latest findings of Emergen Research (Surrey, BC, Canada; www.emergenresearch.com), a market research and consulting company. VR has been widely used in the field of healthcare over the recent past and is applied in a broad range of applications such as medical training, disease treatment, and medical education, among others. VR comprises output tools, input devices, graphical manufacturing system and information software of a virtual environment. VR has emerged as a powerful diagnostic tool to help doctors and physicians carry out accurate diagnosis in combination with other imaging tests, which can further eliminate the need for invasive techniques. VR is also being widely used in rehabilitation and treatment over conventional physiotherapy. The benefits of using VR is that it allows multiple repetitions of simple tasks in clinical practice without needing supervision, enables easy use of head-mounted devices in patients with mobility issues which ensures pleasurable and convenient environment, and facilitates easy collection of data for efficient monitoring of progress. The application of VR in surgical training can also drastically reduce probability of surgical errors, in turn, improving patient safety. Training and treatment through VR environments could save resources need for critical tasks, and this can further reduce the costs and financial burden on healthcare organizations.
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ATTENTION: Due to the CORONAVIRUS PANDEMIC, many events are being rescheduled for a later date, converted into virtual venues, or altogether cancelled. Please check with the event organizer or website prior to planning for any forthcoming event EHA 2022 - Annual Congress of the European Hematology Association. Jun 9-12; Vienna, Austria; ehaweb.org SIR 2022 – 47th Annual Meeting of the Society of Interventional Radiology. Jun 11-16; Boston, MA, USA; sirmeeting.org Medical Taiwan 2022. Jun 16-18; Taipei, Taiwan; medicaltaiwan.com.tw ESTS 2022 – 30th Meeting of the European Society of Thoracic Surgeons. Jun 19-21; The Hague, Netherlands; ests.org ESRA 2022 – 39th Annual Congress of the European Society of Regional Anaesthesia and Pain Therapy. Jun 22-25; Thessaloniki, Greece; esra2022.com EFORT Congress 2022 – 23rd Annual Congress of European Federation of National Associations of Orthopaedics and Traumatology. Jun 22-24; Lisbon, Portugal; congress.efort.org SCR 22 – Swiss Congress of Radiology. Jun 23-25; Fribourg, Switzerland; congress.sgr-ssr.ch ASCI 2022 – 15th Congress of the Asian Society of Cardiovascular Imaging. Jun 24-26; Hong Kong; asci-2022.org 8th Congress of the European Academy of Neurology (EAN). Jun 25-28; Vienna, Austria; ean.org
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NASCI 2022 – Annual Meeting of the North American Society for Cardiovascular Imaging. Sep 10-13; Cleveland, OH, USA; nasci.org
JFR 2022 - Journées Francophones de Radiologie. Oct 7-10; Paris, France; jfr.radiologie.fr
CIRSE 2022 – Annual Congress of the Cardiovascular and Interventional Radiological Society of Europe. Sep 10-14 Barcelona, Spain; cirse.org REHACARE 2022 – International Trade Fair for Rehabilitation and Care. Sep 14-17; Dusseldorf, Germany; rehacare.com ESPE 2022 - 60th Annual Meeting of the European Society for Paediatric Endocrinology. Sep 15-17; Rome, Italy; eurospe.org ISUOG World Congress 2022 - International Society of Ultrasound in Obstetrics & Gynecology. Sep 1618; London, UK: isuog.org MICCAI 2022 – 25th International Conference on Medical Image Computing and Computer Assisted Intervention. Sep 18-22; Singapore; miccai2022.org
EAPS 2022 – 9th Congress of the European Academy of Paediatric Societies. Oct 7-11; Barcelona, Spain; eaps2022.kenes.com UEG Week 2022 – United European Gastroenterology. Oct 8-11; Vienna, Austria; ueg.eu/week Medical Japan 2022 Tokyo– International Medical and Elderly Care Expo. Oct 12-14; Tokyo, Japan; medical-jpn.jp EANM 2022 – 35th Annual Congress of the European Association of Nuclear Medicine. Oct 15-19; Barcelona, Spain; eanm.org EUSEM 2022 – 16th European Emergency Medicine Congress. Oct 15-19; Berlin, Germany; eusem.org Asia Health 2022. Oct 19-21; Bangkok, Thailand; medlabasia.com
SEACare 2022 – 23rd Southeast Asian Healthcare & Pharma Show. Sep 19-21; Kuala Lumpur; Malaysia; abcex.com
ESSO 41 – 41st Congress of the European Society of Surgical Oncology. Oct 19-21; Bordeaux, France; esso41.org
EASD 2022 – 58th Annual Meeting of the European Association for the Study of Diabetes. Sep 19-23; Stockholm, Sweden; easd.org
ESICM LIVES 2022 – Annual Congress of European Society of Intensive Care Medicine. Oct 22-26; Paris, France; esicm.org
ESVS 2022 – Annual Meeting of the European Society for Vascular Surgery. Sep 20-23; Rome,
ANESTHESIOLOGY 2022 – Annual Meeting of the American Society of Anesthesiologists. Oct 22-26;
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International Calendar
ISS 49th Annual Meeting – International Skeletal Society. Oct 23-28; Barcelona, Spain; internationalskeletalsociety.com 14th World Stroke Congress – World Stroke Organization. Oct 26-29; Singapore; worldstrokecongress. org Africa Health 2022. Oct 26-28; Johannesburg, South Africa; africahealthexhibition.com RANZCR 2022 – Annual Scientific Meeting of The Royal Australian and New Zealand College of Radiologists. Oct 27-30; Adelaide, Australia; ranzcr.com ESGO 2022 – 23rd European Congress on Gynaecological Oncology. Oct 27-30; Berlin, Germany; congress.esgo.org
NOVEMBER 45th World Hospital Congress of the International Hospital Federation (IHF). Nov 9-11; Dubai, UAE; worldhospitalcongress.org CBMI 2022 – 27th Brazilian Congress of Intensive Care Medicine. Nov 10-12; Brasilia, Brazil; amib. org.br MEDICA 2022. Nov 14-17; Dusseldorf, Germany; medica-tradefair.com APSR 2022 – 26th Congress of the Asian Pacific Society of Respirology. Nov 17-20; Seoul, Korea; apsr2022.org RSNA 2022 - Annual Meeting of the Radiological Society of North America. Nov 27 - Dec 1; Chicago, IL, USA; rsna.org
DECEMBER Zdravookhraneniye 2022 – Russian Health Care Week. Dec 5-9; Moscow, Russia; zdravo-expo.ru
2023 JANUARY Arab Health 2023. Jan 30 – Feb 2; Dubai, UAE; arabhealthonline.com
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