HospiMedica International September 2021 by Globetech

WORLD’S CLINICAL NEWS LEADER Vol.39 No.3 • 8-9/2021

SBRT Treats Multiple Metastatic Tumors

new study suggests that stereotactic body radiotherapy (SBRT) can be used effectively for treating patients with multiple metastases. Researchers at Fox Chase Cancer Center (Philadelphia, PA, USA; www.foxchase.org), the University Cont’d on page 21

ISSN 0898-7270

AI Tool Simplifies Thyroid Ultrasound Scanning Workflow

new artificial intelligence (AI) algorithm views and quantifies ultrasound image data to aid rapid diagnosis of thyroid gland nodules. The Medo (Edmonton, Canada; www.medo.ai) Medo-Thyroid software solution uses AI and ma-

chine learning to radically simplify the classification of thyroid nodules. Users simply save sweeps of each thyroid lobe, and Medo automatically analyses these to select the most relevant image of the nodule and calculate standard lobe and isthmus measurements. Cont’d on page 13

Follow-Up Studies Offer Key Insights into COVID-19 Vaccine Efficacy L

Robotic Platform Steers Surgical Catheters

new study describes how a prototype system uses electromagnetic fields to automatically guide surgical catheters, providing a possible alternative to manual steering. The Advanced Robotics for Magnetic Manipulation (ARMM) system, developed at the University of Twente (UT; Enschede, The Netherlands; www.utwente. nl), is based on a cored mobile Cont’d on page 18

Robotics Advances Spinal Surgery

highly accurate one-step surgical tool with a real-time tracking sensor provides practitioners with fast, simple, and precise pedicle screw insertion. The Curexo (Seoul, Korea; www. curexo.com) CUVIS-Spine is a nextgen spinal surgery robot that guides the insertion of a pedicle screw according to the surgery plan. The system includes uses a high precision robot arm and wireless,

arge-scale follow-up studies conducted on those vaccinated by the Pfizer-BioNTech COVID-19 vaccine shed new light on how long antibodies last, effects on various types of patients, and effectiveness against the Delta variant. See article on Page 3

Cont’d on page 13 V

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Healthcare Ecosystem Unlocks Patient Monitoring Potential

universal platform connects patients, health providers, devices, and healthcare systems, streamlining workflows, enhancing clinical decision-making, and improving patient privacy.

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

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Baxter to Acquire Hillrom, Eyeing Connected Care Thrust Worldwide

wo global medical technology giants have decided to join forces by way of Baxter’s acquisition of Hillrom for approximately $10.5 billion in cash. Amounting to a total enterprise value of approximately $12.4 billion including as-

sumption of debt, the transaction is expected to close in early 2022. With the Hillrom acquisition, Baxter anticipates to forge a highly complementary product portfolio and innovation pipeline that would expand its offerings worldwide, as Cont’d on page 14

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

News Update. . . . . . . . . 19 Product News . . . . . . 20-24

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

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COVID-19 Update

Follow-Up Research Offers Key Insights into COVID-19 Vaccine Efficacy

atest scientific findings from a series of wide-ranging follow-up studies conducted into the effects and effectiveness of the Pfizer-BioNTech COVID-19 vaccine provide answers to key questions such as how long antibodies last, which patient populations are the worst affected, and how effective is the vaccine against the Delta variant of the novel SARS-CoV-2 coronavirus. Israel, which has been at the forefront of vaccinating its citizens, has also carried out extensive follow-up studies on the effects and effectiveness of the Pfizer-BioNTech COVID-19 vaccine. In an analysis of more than 26,000 blood samples, researchers at Tel Aviv University (Tel Aviv, Israel; www.tau.ac.il) and Shamir Medical Center (Be’er Ya’akov, Israel; www.assafh.org) found that COVID-19 antibody levels vary according to age and gender. Their study revealed that symptomatic females infected with COVID-19 had the strongest immune reaction after the age of 50 years while symptomatic infected males showed the strongest immune reaction at the age of around 35 years. The scientists have attributed these differences to hormones. The researchers also found that vaccinated people had an immune response that was four times stronger as compared to COVID-19 patients who had recovered. In another study of 17 hospitals, researchers at Samson Assuta Ashdod Hospital (Ashdod, Israel; www.assuta ashdod.co.il) found that older individuals who had several underlying medical conditions and immunosuppression were more prone to SARS-CoV-2 infection and severe COVID-19 despite being fully vaccinated. A team led by Sheba Medical Center (Ramat Gan, Israel; www.sheba.co.il) also undertook a study to explore whether mRNA vaccines such as Pfizer’s negatively impacted fertility. Their study revealed that fully vaccinated couples exhibited no differences in sperm quality, semen volume, ovarian stimulation or proportion of high-quality embryos in comparison to their IVF cycles before vaccination. Similarly, a study by the Hadassah-Hebrew University Medical Center (Jerusalem, Israel; www.esmo. org) found that the COVID-19

HospiMedica International August-September/2021

vaccine did not have any effect on sperm parameters. Another study conducted by Sheba Medical Center in collaboration with the Pasteur Institute (Paris, France; www.pasteur.fr) and Sorbonne Université (Paris, France; www. sorbonne-universite.fr) found that among all vaccinated members living in the same house, the risk of contracting COVID-19 for any household member declined from 57% to 4%. Even a single household member inoculated with the Pfizer vaccine significantly reduced the risk to unvaccinated household members. This confirmed findings from an earlier study that had indicated fully vaccinated individuals appeared to enjoy protection from COVID-19

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even after being exposed to family members who were infected. The effectiveness of the Pfizer COVID-19 vaccine in preventing infections and symptomatic illness declined to 64% in early July from a high of 95% reported in May by the Israeli Health Ministry. This can be attributed to the entry of the Delta variant into the country. The same ratio fell further to about 40% as per a report released July 22, most likely due to the effects of the vaccinations administered in January and February wearing off over time. The early July report had stated that the vaccine was 93% effective in preventing serious illness from COVID-19, while this number the late Cont’d on page 12

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COVID-19 Update

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 May 1, till July 31, 2021. For a recap of earlier developments, the reader is invited to refer to previous issues of HospiMedica or visit www.HospiMedi ca.com. Automated CT Image-Based AI Model Predicts Disease Progression and Mortality in COVID-19 Patients Researchers at Brigham and Women’s Hospital (Boston, MA, USA; www. massgeneralbrigham.org) have developed an automated image-based survival prediction model based on deep learning of chest computed tomography (CT) images for fast and accurate clinical assessment of COVID-19 progression and mortality. In an evaluation of the model, called U-survival, the results indicated that it can be used to provide automated and objective prognostic predictions for the management of COVID-19 patients. First-Ever Biomarker Reliably Predicts Severe COVID-19 Cases Early On Researchers at the University of Zurich (Zurich, Switzerland; www.uzh.ch) have identified the first biomarker that can reliably predict which COVID-19 patients will develop severe symptoms, thereby helping to improve the treatment of severe cases. The biomarker - the number of natural killer T cells in the blood - can be used to predict severe cases of COVID-19 with a high degree of certainty even on a patient’s first day in hospital. Global Ivermectin Use Can Stop COVID-19 Pandemic in Its Tracks, Claims New Research A group of medical and scientific experts led by the Front Line COVID-19 Critical Care Alliance (FLCCC; Washington, DC, USA; www.covid19criticalcare. com) has reviewed published peer-reviewed studies, manuscripts, expert meta-analyses, and epidemiological analyses of regions with ivermectin distribution efforts all showing that ivermectin is an effective prophylaxis and treatment for COVID-19. The research was peer reviewed by medical experts that included three US government senior scientists and published in the American Journal of Therapeutics, and is the most comprehensive review of the available data taken from clinical, in vitro, animal, and real-world studies. Ultrasound Stimulation Reduces COVID-19-Related Inflammation and Decreases Length of Hospital Stays Researchers at University of Califor-

nia San Diego School of Medicine (San Diego, CA, USA; www.health.ucsd.edu) have begun a pilot clinical trial to test the efficacy of using ultrasound to stimulate the spleen and reduce COVID-19-related inflammation, decreasing the length of hospital stays. The two- to three-month study, called Ultrasound Neural and Immunomodulation Treatment Evaluation Study for COVID-19 or UNITE Study, by researchers, will recruit 40 patients with severe COVID-19 symptoms. The clinical trial will use an investigational device strategically placed on patients’ skin that generates low-intensity, focused ultrasound waves targeting the spleen.

Inhalable Nanobody-Based Treatment Administered at Ultra-Low Doses Could Prevent and Treat SARS-CoV-2 Infections A new study by scientists from the University of Pittsburgh School of Medicine (Pittsburgh, PA, USA; www.medschool. pitt.edu) has found that inhalable nanobodies targeting the spike protein of the SARS-CoV-2 coronavirus can prevent and treat severe COVID-19 in hamsters. The scientists have shown that inhalable nanobodies targeting the spike protein of the SARS-CoV-2 coronavirus can prevent and treat severe COVID-19 in hamsters. This is the first time the nanobodies - which are similar to monoclonal antibodies but smaller in size, more stable and cheaper to produce - were tested for inhalation treatment against coronavirus infections in a pre-clinical model. GlaxoSmithKline and Vir Biotechnology’s COVID-19 Antibody Drug Granted FDA Emergency Use Authorization GlaxoSmithKline plc (London, UK; www.gsk.com) and Vir Biotechnology, Inc. (San Francisco, CA, USA; www.vir. bio) have been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for sotrovimab (previously VIR-7831) for the treatment of mild-to-moderate COVID-19 in high-risk

Cont’d on page 5

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First-Ever Peptide-Based Drugs Could both Prevent and Treat COVID-19 Scientists from QIMR Berghofer Medical Research Institute (Queensland, Australia; www.qimrberghofer.edu.au) have developed two new drugs to both prevent SARS-CoV-2 infection, and also treat people who have been exposed to the virus so they do not develop severe disease. The peptide-based drugs are now being tested in hamsters, with promising early results showing they are not toxic and have few side effects. The drugs are also stable and can be stored at room temperature - which would make them easy to distribute.

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ISSN 0898-7270

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

HospiMedica International August-September/2021

COVID-19 Update Cont’d from page 4

adults and pediatric patients. Sotrovimab is an investigational single-dose monoclonal antibody that has been granted an EUA by the FDA for the treatment of mild-to-moderate COVID-19 in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progression to severe COVID-19, including hospitalization or death. New Drug That Blocks Multiple SARS-CoV-2 Variants Could Be a Game-Changer in Treating COVID-19 Infection Scientists at Penn Medicine (Philadelphia, PA, USA; www.pennmedicine.org) have discovered a new drug that blocks multiple SARS-CoV-2 variants in mice and could prove to be a potential game-changer in the treatment of COVID-19. The drug diABZI activates the body’s innate immune response and was highly effective in preventing severe COVID-19 in mice infected with SARS-CoV-2. The findings suggest that diABZI could also treat other respiratory coronaviruses.

have been able to translate the expertise of top lung specialists into a software update for these ultrasound machines. This enables relative laymen to interpret the images in a manageable and comparatively inexpensive manner, just like the world’s best lung experts. First-In-Class Nasal Spray Could both Treat and Prevent COVID-19 A first-in-class nasal spray is being developed by ENA Respiratory (Perth, Australia; www.enarespiratory.com) for the treatment as well as prevention of COVID-19 and other respiratory viral infections. ENA is developing its lead clinical candidate, INNA-051, to activate innate immunity in the nose, the primary site of most respiratory virus infections, including COVID-19. The company is poised to initiate its Phase I human safety

study of INNA-051 in the coming weeks. Fujitsu to Detect and Analyze New COVID-19 Drugs by Leveraging World’s Fastest Supercomputer Fujitsu Japan Limited (Tokyo, Japan; www.fujitsu.com), along with the Research Center for Advanced Science and Technology (RCAST) at the University of Tokyo (Tokyo, Japan; www.u-tokyo.ac.jp), has initiated a new research project utilizing the world’s fastest supercomputer for identifying new COVID-19 therapies. The research will leverage Fugaku, the world’s fastest supercomputer jointly developed by RIKEN and Fujitsu, to identify small molecule inhibitory compounds that can be used as potential drugs in treatments for COVID-19, as well as clarifying the molecular mechanism by which COVID-19 Cont’d on page 6

AI-enhanced EKG Can Be |Used as Rapid, Reliable COVID-19 Screening Test to Rule out Infection Artificial intelligence (AI) may offer a way to accurately determine that a person is not infected with COVID-19, according to the findings of an international retrospective study led by researchers at Mayo Clinic (Rochester, MN, USA; www.mayoclinic.org). The study found that infection with SARS-CoV-2, the virus that causes COVID-19, creates subtle electrical changes in the heart. An AI-enhanced EKG can detect these changes and potentially be used as a rapid, reliable COVID-19 screening test to rule out COVID-19 infection. Intelligent Lung Ultrasound Provides Crucial Support for COVID-19 Testing Within Minutes Using fairly simple ultrasound machines that are enhanced with artificial intelligence (AI) could make it possible to establish whether a patient is suffering from severe lung disease, possibly COVID-19, within a few minutes, according to a research team at Eindhoven University of Technology (Eindhoven, Netherlands; www.tue.nl) and the University of Trento (Trento, Italy; www.unitn.it). The researchers

HospiMedica International August-September/2021

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PRODUCT NEWS

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COVID-19 Update Cont’d from page 5

infections are inhibited, leading to the eventual development of small molecule therapeutic drugs. COVID-19 Patients Recover Faster With Metabolic Activator Treatment, Study Shows Metabolic activators can reduce recovery time by as many as 3.5 days in patients with mild-to-moderate COVID-19, according to a new study by researchers from the Science for Life Laboratory (SciLifeLab) at KTH Royal Institute of Technology (Stockholm, Sweden; www.kth.se). The researchers also found that treatment with the metabolic activators improved liver health and decreased the levels of inflammation, as shown by inflammatory markers. New Immunotherapy Platform Deploys Engineered Molecules to Inhibit SARS-CoV-2 Infection and Remove COVID-19 Infected Cells A pioneering immunotherapy platform developed by Anna Biosciences (Dublin, Ireland; www.annabiosciences.com) that deploys engineered proprietary molecules to create synthetic immunity could aid in the fight against COVID-19. The Anna Biosciences Syntem Platform deploys engineered proprietary molecules to create synthetic immunity. Syntem’s lab-made molecules are multi-specific: they first target and flag the pathology, and then elicit an immune reaction that targets the virus or disease. Research indicates the Syntem Platform can inhibit viral infection and aid in the removal of COVID-19 infected cells. CT Scans Prove Highly Accurate In Diagnosing COVID-19 Pneumonia and Predicting Death or Need for Intubation In a new study involving more than 10,000 patients, researchers found that chest computed tomography (CT) was 80% accurate in diagnosing COVID-19 pneumonia and predicting death or the need for intubation. The researchers found that using predefined criteria and RT-PCR as the reference standard in 10735 subjects with suspected COVID-19 pneumonia, CT diagnostic accuracy for COVID-19 was 80%, which increased to 86% after five days of symptoms. The extent of pneumonia at CT (OR, 3.25) was the best predictor of severe outcome (intubation or death) at one month.

MAGNAMED TECNOLOGIA

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Tapeworm Drug Niclosamide Shows Strong Antiviral Effect as Potential New Treatment for COVID-19 Researchers from the German Center for Infection Research (DZIF; Berlin, Germany; www.dzif.de) examining the way in which SARS-CoV-2 reprograms the metabolism of the host cell in order to gain an overall advantage were able to identify four substances, including the tapeworm drug niclosamide, which inhibit the virus replication in the host cell. The researchers are currently conducting a trial to determine whether niclosamide is also effective against COVID-19 in humans. Blood and Imaging Tests Can Be Used to Screen COVID-19 Patients Most at Risk of Heart Complications Researchers at Johns Hopkins University (Baltimore, MD, USA; www.jhu.edu) have shown how blood tests and echocardiograms can be used to screen patients with COVID-19 for atrial fibrillation and other heart complications. The researchers have shown that a type of echocardiogram may be useful in predicting which patients with COVID-19 are most at risk of developing atrial fibrillation. The new findings also suggest that patients with COVID-19 who go on to develop atrial fibrillation more commonly have elevated levels of heart-related proteins called troponin and NT-proBNP in blood test samples. Gilead’s Remdesivir Reduced Mortality in Hospitalized COVID-19 Patients, Shows Real-World Data Analyses Gilead Sciences (Foster City, CA, USA; www.gilead.com) has announced positive data from three retrospective studies of the real-world treatment of patients hospitalized with COVID-19, adding to the body of mortality and hospital discharge data for patients treated with Veklury (remdesivir). All three of the real-world analyses observed that, in the overall patient populations, patients who received Veklury treatment had significantly lower risk for mortality compared with matched controls. A reduction in mortality was observed across a spectrum of baseline oxygen requirements. The results were consistently observed at different timeframes over the course of the pandemic and across geographies. Lung Ultrasound Used to Manage Critically Ill COVID-19 Patients Leads to Huge Time Savings as Compared to Chest CT The use of lung ultrasound allows medical personnel to monitor the progress of COVID-19 patients with considerable time savings as compared to traditional radiology, according to new research Cont’d on page 7 HospiMedica International August-September/2021

COVID-19 Update Cont’d from page 6

by the University of Udine (Udine, Italy; www.uniud.it). Lung ultrasound is a well-established diagnostic tool in acute respiratory failure, and it is particularly suited for identification, grading, and follow-up of lung involvement severity. In critically ill COVID-19 patients, lung ultrasound is an alternative to chest radiography, chest CT or electric impedance tomography to quantify pulmonary impairment, follow lung involvement changes, or predict an intensive care unit (ICU) stay of more than 30 days or death. Monoclonal Antibody Therapy Reduces Hospitalizations When Given Early To Patients at High Risk for Severe COVID-19 Timely treatment with COVID-19 monoclonal antibodies (MABs) can reduce hospitalizations and the pandemic’s stress on health care systems, according to a collaborative study by the University of South Florida Health (USF Health; Tampa, FL, USA; www.health.usf.edu) and Tampa General Hospital (TGH; Tampa, FL, USA; www.tgh.org). The study shows that MABs work well in reducing COVID-19 related emergency department visits and hospitalizations when given early to high-risk patients. If used under FDA guidelines, the researchers suggest, this treatment can ease the pandemic’s continuing burden on patients and on limited health care resources. Roche’s Actemra Granted US FDA EUA for Treatment of Hospitalized COVID-19 Patients Roche (Basel, Switzerland; www.roche.com) has been issued an Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA) for Actemra/RoActemra for the treatment of COVID-19 in hospitalized adults and children. The FDA EUA has been granted for intravenous Actemra/RoActemra (tocilizumab) for the treatment of COVID-19 in hospitalized adults and pediatric patients (two years of age and older) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).

and Technology (KAIST; Daejeon, Korea; www.kaist.ac.kr) has identified repurposed drugs for COVID-19 treatment through virtual screening and cell-based assays. The research team has suggested the strategy for virtual screening with greatly reduced false positives by incorporating pre-docking filtering based on shape similarity and post-docking filtering based on interaction similarity. The strategy will help develop therapeutic medications for COVID-19 and other antiviral diseases more rapidly. New Biosensor Detects COVID-19 and SARS-CoV-2 Variants on People’s Breath within a Minute RMIT University (Melbourne, Australia; www.rmit.edu.au), in collaboration with Soterius Pty Ltd. (Melbourne, Australia; www. soterius.com.au), has developed an instant COVID-19 sensor that could help transform day-to-day management of the pandemic, protecting frontline workers and the wider community. The biosensor can detect the presence of tiny amounts of the SARSCoV-2 virus and its variants. AACC Advises against Using Coronavirus Test CT Values to Guide COVID-19 Patient Care The American Association for Clinical Chemistry (AACC; Washington, DC, USA; www.aacc.org) has issued a public statement advising against the use of coronavirus test cycle threshold (Ct) values to guide COVID-19 treatment or public health efforts. AACC members have released a statement that details the limitations of Ct values and recommends against their use. The statement emphasizes that, even though Ct values correlate with the amount of virus in specific specimens, studies have not actually established a relationship between Ct values and a patient’s overall viral load or infectiousness.

Face Mask with Wearable Biosensors Accurately Diagnoses COVID-19 within 90 Minutes Researchers from The Wyss Institute for Biologically Inspired Engineering at Harvard University (Boston, MA, USA; www. wyss.harvard.edu) and the Massachusetts Institute of Technology (Cambridge, MA, USA; www.mit.edu) have found a way to embed synthetic biology reactions into face masks, creating wearable biosensors that can be customized to enable rapid, accurate detection of SARS-CoV-2 and many other pathogens and toxins. The button-activated mask gives results within 90 minutes at levels of accuracy comparable to standard nucleic acid-based diagnostic tests like polymerase chain reactions (PCR). Machine Learning Algorithm Trained on Images of Everyday Items Detects COVID-19 in Chest X-Rays with 99% Accuracy A new study by researchers at Edith Cowan University (Perth, Australia; www.ecu.edu.au) using machine learning on images of everyday items is improving the accuracy and speed of detecting respiratory diseases, reducing the need for specialist medical expertise. The results of this technique, known as transfer learning, achieved a 99.24% success rate when detecting COVID-19 in chest X-rays. The study tackles one of the biggest challenges in image recognition machine learning: algorithms needing huge quantities of data, in this case images, to be able to recognize certain attributes accurately. Researchers Use Virtual Screening and Cell-Based Assays to Identify Repurposed Drugs for COVID-19 Treatment A team of scientists from Korea Advanced Institute of Science

HospiMedica International August-September/2021

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PRODUCT NEWS

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Early MRI Helps Identify Takotsubo Cardiomyopathy

new study suggests that early cardiovascular magnetic resonance (CMR) imaging of the heart can greatly increase broken-heart syndrome diagnosis rates. Researchers at Karolinska Institutet (Solna, Sweden; www.ki.se), the Kolling Institute (Sydney, Australia; www.kollinginstitute.org.au), Karolinska University Hospital (Stockholm, Sweden; www.karolinska.se), and oth-

er institutions conducted a prospective study involving 148 patients with myocardial infarction with non-obstructed coronary arteries (MINOCA) in order to determine if 1.5-T CMR imaging with T1 and extracellular volume mapping early after hospital admission could aid diagnosis; 150 patients with MINOCA imaged using 1.5-T CMR without mapping techniques served as historic controls. The results showed that 77% of the patients imaged together with extracellular volume mapping could be given a diagnosis (35% of Takotsubo syndrome and 17% of myocardial inflammation), compared with 19% and 7% (respectively), in those imaged without mapping techniques. The early CMR imaging with extracellular volume mapping also detected significantly more wall motion abnormalities, edema, and late gadolinium enhancement, compared to those examined without mapping techniques. The study was published on April, 14, 2021, in JACC Cardiovascular Imaging. “Around eighty to ninety per cent of broken-heart sufferers are women, and the disease is associated with mental stress,” said senior author Professor Per Tornvall, MD, PhD, of Karolinska Institutet. “There also seems to be a link to hypersensitivity towards stress caused by low oestrogen levels. Unfortunately, research on the investigation and treatment of myocardial infarction is often done on men, while female heart disease is less studied.” Takotsubo syndrome occurs in response to physical or emotional distress and causes dysfunction or failure in the heart muscle. Patients typically experience symptoms similar to a heart attack, such as chest pain and shortness of breath, but usually do not have acutely blocked coronary arteries. The left ventricle of the heart, however, may show enlargement. Other symptoms include irregular heartbeat, fainting, low blood pressure, and cardiogenic shock. Patients generally recover in a matter of days or weeks, although the condition can occasionally cause major adverse cardiac and cerebrovascular events, and rarely can be fatal. HospiMedica International August-September/2021

MRI Helps Create Personalized Brain Temperature Maps

new study shows how data from magnetic resonance imaging (MRI) of brain tissue and vessel structure can facilitate personalized brain temperature predictions. Developed by researchers at the Georgia Institute of Technology (Georgia Tech; Atlanta, GA, USA; www.gatech.edu) and Emory University (Atlanta, GA, USA; www.emory.edu), the biophysical model can be used to generate 3D thermal distribution maps using whole brain MRI-based thermometry data. The model relies on two fundamental physical principles, conservation of energy and conservation of mass, to predict how heat is generated through metabolism and dissipated via blood flow throughout the brain, via conduction, convection, and advection. For the study, the researchers first collected structural MRI brain images from three healthy volunteers. After several hours of data analysis and simulations, the biophysical model computed the distribution of brain temperature in the brain, visualized as three-dimensional (3D) maps. To validate the model, the researchers then collected temperature measurements using whole-brain MRI thermometry, compared these measurements to the model’s predictions, and found that they agreed. The study was published on April 15, 2021, in Communications Physics. “Brain temperature varies throughout the brain as blood flow and metabolic demands change. This means that you cannot assign a single temperature to a brain,” said co-senior author Andrei Fedorov, PhD, of Georgia Tech. “All of the complexity [in the brain’s functioning] results in a very unique personal temperature map that actually tells us a lot about what may be happening to us, what may have happened in the past, or what may happen if we somehow perturb us as a human.” Despite being only a fraction of the human body’s mass, the brain accounts for 20% of total oxygen consumption in resting conditions, which is

used for neuronal metabolism, neural processes, and the functioning of glial, endothelial, and epithelial cells. All this energy is transformed into intense heat production. The brain is also exceptionally well vascularized, receiving 15– 20% of total cardiac output, which also serves as the means to remove the heat continuously generated through brain metabolism and neurological function. Image: Metabolic heat (a), cerebral blood flow (b) and model-predicted brain temperature (c) in three volunteers (Photo courtesy of Emory University)

Personalized Shields Reduce Radiotherapy Tissue Injury

D-printed devices derived from CT images can shield healthy structures in the gastrointestinal (GI) tract during radiation therapy (RT) procedures, according to a new study. Developed at Brigham and Women’s Hospital (BWH; Boston, AM, USA; www.brighamandwomens.org), the Massachusetts Institute of Technology (MIT; Cambridge, MA, USA; www.mit.edu), Massachusetts General Hospital (MGH; Boston, USA; www.massgeneral.org), and other institutions, the personalized shields were designed and contoured on diagnostic CT scans using the open-source 3D Slicer software app. The contours were then generated into 3D models, and the personalized radioprotective shields were 3D-printed with high atomic number materials to block gamma and x-rays and reduce radiation backscatter. In initial testing on rats and pigs, the researchers found that the devices could protect healthy tissue in the mouth and rectum in rats and were feasible and reproducible in pigs. In human simulation studies, dosimetric modeling showed a 30% dose reduction to the normal buccal mucosa in maxillofacial cancer patients, and a 15.2% dose reduction in the rectum for prostate cancer patients. They also suggest that the new shields are more cost-effective than a hydrogel rectal spacer. The study was published on April 27, 2021, in Advanced Science. “Personalized 3D-printed radioprotectant devices may have great potential to reduce radiation toxicity in clinical settings where radiation is used, including neoadjuvant and adjuvant therapy, curative treatment, and palliative treatments,” concluded lead author James Byrne, PhD, of BWH, and colleagues. “This personalized approach could be applicable to a variety of cancers that respond to radiation therapy, including head and neck, lung, prostate, anal, skin, and gynecological cancers, sarcomas, and lymphomas.” Most cancer patients undergoing RT will develop colateral tissue injury as a result of treatment. The toxicities are dependent upon the location of treatment, with the most common toxicities involving the oral cavity and gastrointestinal (GI) tract in the forms of oral mucositis, esophagitis, and proctitis. This injury may lead to severe morbidity and, ultimately, treatment breaks or discontinuation that adversely impact tumor cure rates.

HospiMedica International August-September/2021

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RADIATION MEASUREMENT DEVICE RADCAL

OB/GYN ULTRASOUND SYSTEM MINDRAY PATIENT MONITORING

MAMMOGRAPHY WITH DIGITAL TOMOSYNTHESIS MS WESTFALIA

The 10X6-60DAP ion chamber has been specifically designed for use in measuring dose area product (DAP) for dental applications (e.g. cone beam CT, pan-dental, etc.).

The Nuewa I9 is a cart-based OB/GYN diagnostic ultrasound system combining innovative design and exceptional imaging quality to deliver efficient care covering the entire continuum (pre-pregnancy to obstetrics and post-partum).

The GAIA TOMO is a mammography system with digital tomosynthesis that receives 2D and 3D images of stunning quality, clearly displaying lesions and areas of interest, as well as reducing the dose received by the patient.

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Advanced MRI Visualizes Pulsatile Brain Motion

n advanced magnetic resonance imaging (aMRI) technique can capture three dimensional (3D) brain movements in real time, according to a new study. Developed at Matai Medical Research Institute (Matai; Gisborne, New Zealand; www.matai.org.nz), Stanford University (CA, USA; www.stanford.edu), and other institutions, 3D aMRI builds on previous 2D aMRI, and can show minute movements of the brain at a spatial resolution of just 1.2mm3, about the width of a human hair. The actual movements are amplified by up to a factor of 25 to allow detailed inspection of the movements. The detailed, animated, and magnified movements can help clinicians identify abnormalities, such as those caused by blockages of spinal fluids. The researchers also qualitatively compared 3D aMRI to 2D aMRI on multi-slice and volumetric balanced steady-state free precession cine data and phase contrast MRI (PC-MRI), using 3T scans acquired from healthy volunteers. The volumetric 3D aMRI data was also used to generate optical flow maps and 4D animations that reveal complete brain tissue and cerebrospinal fluid (CSF) motion, serving to highlight the piston-like motion of the four brain ventricles. The study was published on May 5, 2021, in Magnetic Resonance in Medicine. “The new method magnifies microscopic rhythmic pulsations of the brain as the heart beats to allow the visualization of minute piston-like movements, that are less than the width of a human hair,” said lead author Itamar Terem, MSc, a graduate student at Stanford. “The new 3D version provides a larger magnification factor, which gives us better

visibility of brain motion, and better accuracy.” “This fascinating new visualization method could help us understand what drives the flow of fluid in and around the brain. It will allow us to develop new models of how the brain functions that will guide us in how to maintain brain health and restore it in disease or disorder,” said study co-author Miriam Sadeng, MD, PhD, of the University of Auckland department of anatomy and medical imaging. “The optical flow maps and 4D animations of 3D aMRI may open up exciting applications for neurological diseases that affect the biomechanics of the brain and brain fluids.” aMRI is based on the use of a phase-based motion magnification algorithm applied to 2D multi-slice cardiac gated (cine MRI) data, which results in an amplified “movie” of brain motion. aMRI has also shown promise for visualizing cerebrovascular motion using amplified flow imaging (aFlow), which can capture the characteristics of transient events present in brain tissue, such as blood flow interaction with arterial walls, when applied to 3D PC-MRA. Image: Brain displacement patterns enabled by extra processing of 3D aMRI (Photo courtesy of Mātai)

Application-Rich Ultrasound Empowers Informed Decisions

new ultra-performance ultrasound system supports a full range of shared service diagnostic imaging environments and unique visualization tools. The Esaote (Genova, Italy; www.esaote. com) MyLab X9 64-bit X ULTRA ultrasound system offers a wide range of premium technologies, including a high quality 24” Barco Eonis monitor, and highly sensitive probes with single crystal technology and appleprobe ergonomics, which reduce muscoloskeletal strain. Additional ergonomic and workflow enhancements include easyMode,

touch-tool image optimization that uses intelligent real-time algorithms; Opti-light, an integrated light fixture that ensuring the best environment for optimal scanning; and the eStreaming solution for sharing clinical images and camera stream in real-time on various devices, such as tablets, mobiles, and laptops. A multi-parameter approach enhances diagnosis with innovative packages, such as BreastNav MRI for fusion imaging of breast ultrasound and MRI; Virtual Navigator fusion imaging function for liver disease diagnosis, staging, monitor-

ing, and treatment guidance of focal lesions; UroFusion, a new real-time image Cont’d on page 11 HospiMedica International August-September/2021

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Medical Imaging

Ergonomic Positioning System Reduces Radiologist Burden

ovel power assist technology rapidly calculates the amount of assist-force required to position the radiographic system head precisely in position. The Shimadzu Medical Systems (SMS; Kyoto, Japan; www. shimadzu.com) Power Glide system was developed for the company’s high-end radiographic systems. It is designed to instantaneously sense the amount of force applied by an operator during each movement, calculate the amount of assist-force required, and activate the positioning motors of the radiography system, thus providing effortless operating assistance for the radiographic environment. And as the force applied to the handle during operation varies among operators, the amount of power assist required differs as well. The assist-force can be selected among three levels (low/ mid/high) on the X-ray tube support touch panel. This ensures smooth operability by switching to a lower assist level for fine positioning, or to a higher assist level for performing large Xray tube support movements quickly. Systems also include convenient functionality that makes fine positioning easier by automatically reducing the assist level whenever LED lamps are illuminated to point out the X-ray exposure field for fine positioning of the exposure area. An extensive selection of various optional functionalities is also available, such as an auto-positioning functionality that can automatically move the X-ray tube support to registered positions; tomosynthesis functionality that can generate multi-slice images; or speed-stich functionality to generate long-view images for full spine or full leg examinations. Beyond power assist technology, Power Glide also involves innovations in sensing, shock reduction, balance, stability control, and torque control technologies that enable effortless manual operability of equipment weighing up to 300kg. “In general radiography, the radiological technologist must maneuver an X-ray tube support assembly suspended from ceiling rails to position it to the target exposure area,” stated the company in the press release. “As general radiography is the first choice for diagnostic imaging involving many disorders found in the head, chest, abdomen, extremities and other areas, these daily procedures are used for an extremely large number of examinations. The extremely high responsiveness of Power Glide

ensures the system can be comfortably and quickly positioned as intended in any situation.” General radiography examinations require fine operability to position the X-ray exposure area to within a few millimeters by moving the X-ray tube assembly along ceiling rails. But due to the operator’s risk of shoulder or lower back pain, there is a need to reduce operating loads by improving ergonomics, which also enables a smoother workflow and shortens the time that patients must maintain a particular body position during examinations. Image: Power Glide technology aids precise, ergonomic x-ray tube positioning (Photo courtesy of Shimadzu Medical Systems)

Application-Rich Ultrasound Empowers Informed Decisions

Cont’d from page 10

fusion technology via a transrectal or transperineal approach that supports prostate biopsies and ultrasound-guided focal treatments; QElaXto 2D function for tissue elasticity assessment; and a host of specialized musculoskeletal imaging, sports medicine, and rheumatology IQ-probes that operate at up to 25MHz. “The introduction of MyLab X9 marks an important step in the current international scenario, where many companies have been forced to revise their development and investment plans, precisely because of the pandemic,” said Guillaume Gauthier, global product marketing manager at Esaote. “Artificial intelligence, intuitiveness, connectivity, and multimodality combined with an Italian design improve the daily clinical experience by matching high-quality performance 3-year technical coverage, to reinforce the return on investment.” A large portfolio of iQProbe extended wideband convex, linear, phased array, volumetric, intraoperative and special transducer shapes are available, all featuring active matrix composite materials, single crystal, multiple adaptive layers, and a bi-con geometric lens.

HospiMedica International August-September/2021

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DIGITAL RADIOGRAPHY RANGE AGFA HEALTHCARE

MRI SCANNER SIEMENS HEALTHINEERS

RADIOGRAPHY AND FLUOROSCOPY SYSTEM CANON MEDICAL SYSTEMS

The SmartXR portfolio brings intelligence to digital radiography (DR) equipment at the point of care, combining integrated sensors and cameras with powerful AI software, 3D machine vision, deep learning and machine intelligence.

MAGNETOM Terra is the first 7T MRI scanner for diagnostic imaging and features a Dual Mode that lets users switch between clinical and research operations, with separate databases to distinguish clinical and research scans.

The Adora DRFi combines static and dynamic radiography with low dose fluoroscopy in one system, enabling all radiographic and fluoroscopic examinations and procedures to be performed in a single room.

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Follow-Up Research Offers Key Insights into COVID-19 Vaccine Efficacy

Cont’d from page 3

July report reported a drop in effectiveness to 91%. Additionally, the ministry also found that there was a one-third lower chance of healthy vaccinated individuals developing severe COVID-19 as compared to healthy unvaccinated individuals. These findings were further confirmed by an analysis of medical records of tens of thousands of members of Israeli HMO Leumit Health Fund that indicated individuals who had been vaccinated before late February faced double the risk of a breakthrough SARS-CoV-2 infection as compared to people vaccinated since late February. However, it could not be confirmed whether this was due to the majority of the early vaccinated being elderly people and/or those with chronic health issues, or on account of waning effects of the Pfizer vaccine. A panel of Israeli researchers reported to the Ministry of Health that rare cases of myocarditis, a heart muscle inflammation, were seen in men below the age of 25 years who had taken the second dose of the Pfizer-BioNTech COVID-19 vaccine. However, the majority of the cases were mild and resolved within a few weeks. In late July, the Health Ministry reported that 80% of vaccinated individuals who experienced breakthrough COVID-19 infection did not infect people with whom they came in contact with at public places. Studies carried out during the start of Israel’s vaccination drive found that immunity from the Pfizer-BioNTech COVID-19 vaccine was the strongest 14 days after the first of two doses were administered. The findings also showed that individuals who became infected after taking the first dose demonstrated a significantly lower risk of transmit-

ting the virus to other people. Additionally, the first vaccine dose was found to boost immunity even in individuals who had recovered from COVID-19. In another study, employees of Sheba Medical Center who had taken both doses of the Pfizer vaccine were found to have higher levels of antibodies against SARS-CoV-2 as compared to people who had recovered from COVID-19. Meanwhile, a small study at Tel Aviv Sourasky Medical Center (Tel Aviv, Israel; www.tasmc.org.il) found antibodies being produced in the breastmilk of nursing mothers who were fully vaccinated, thus potentially protecting their babies. In other findings, a study conducted in February showed that individuals who had received Pfizer-BioNTech COVID-19 vaccine were significantly less likely to “shed” or transmit virus particles present in their nose or throat. Another important Sheba Medical Center study showed that among 11,453 fully vaccinated healthcare workers in the medical center, 39 breakthrough cases of COVID-19 were detected through RT-PCR testing of 1,497 of the vaccinated workers between January 20 and April 28. Out of these 39 breakthrough cases of COVID-19, the suspected source of infection was an unvaccinated person in 37 cases. None of the infected workers needed hospitalization, although 19% reported having long COVID-19 symptoms at six weeks after their diagnosis, including prolonged loss of smell, persistent cough, fatigue, weakness, dyspnea, or myalgia. The above study results appeared in the online publication ISRAEL21c, which featured a synopsis of the scientific findings that were reported during January-July, 2021.

Hysterosalpingo Contrast Sonography Helps Infertility Exams

ysterosalpingo contrast sonography (HyCoSy) is potentially safer and more efficient for examination of fallopian tubes than hysterosalpingography (HSG), according to a new study. Researchers at Albert Einstein Medical Center (Philadelphia, PA, USA; www.einstein.edu) conducted a single-center, retrospective study of 28 female patients (average age 32 years) between December 2018 and April 2020. Of these, 17 women had a normal HyCoSy exam, and were therefore not recommended to undergo subsequent hysterosalpingography (HSG). Another four patients had an abnormal HyCoSy, but they did not undergo an HSG within four weeks; however, another seven patients underwent both examinations.

Cont’d on page 21

HospiMedica International August-September/2021

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Medical Imaging

AI Tool Simplifies Thyroid Ultrasound Scanning Workflow

Cont’d from cover

It also segments the nodule (across all images in the sweep) in order to calculate actual volumetric data, as required for TI-RADS scoring, and finally to create individualized interactive reports. “Medo Thyroid makes thyroid ultrasound a less frustrating test, by presenting thyroid measurements and nodule characteristics in a convenient format. It’s especially helpful to radiologists when following up multiple nodules,” said radiologist Jacob Jaremko, MD, co-founder of Medo. “Medo-Thyroid contains several key technological breakthroughs, including a cross-referencing ability previously only possible on multi-plane CT and MRI. This feature is designed to assist the user with viewing individual nodules across all planes of interest, such as transverse and sagittal.”

Cont’d from cover

“Using artificial intelligence, Medo has revolutionized the process of performing thyroid studies and turned it into a seamless, fast, and objective workflow,” said Dornoosh Zonoobi, MD, co-founder and CEO of Medo. “We are particularly pleased with the feedback we have received from many of the independent clinicians who have used our product, stating that this will greatly benefit them in their everyday workflow.” Over 1.5 million thyroid ultrasound exams are performed each year in the United States alone. The high volume is due to the fact that nodules on the thyroid gland are common, and although usually benign, they can be cancerous. Ultrasound exam of the thyroid is time consuming and potentially error-prone, and usually involves tedious review of hundreds of images in order to locate and measure each

HospiMedica International August-September/2021

Image: An example of a Medo-Thyroid interactive report (Photo courtesy of Medo)

Robotics Advances Spinal Surgery

one-step navigation based on a real-time GPS-like sensor that provide precise, safe, and faster surgery, when compared to traditional manual placement. It also minimizes X-ray radiation exposure of both patients and medical staff, as only two slices (AP and LL) are needed for plan the pedicle screws entry point, target point, and route. Both two-dimensional X-ray filming Image: The CUVIS-Spine spinal surgery robot main console (via a C-arm) and three -dimensional (L) and robotic arm (R) (Photo filming (with an O-arm) are available, ex- courtesy of Curexo) panding clinician’s options. The wireless one-step navigation and robot arms allow multiple steps, such as needling, K-wire manipulation, dilation, and tapping) to be performed using just one tool, reducing surgery duration greatly. In order to prevents surgical instruments from skiving, an optical tracking system (OTS) provides accurate data on the lateral force affecting the arm and pedicle screw in real-time. “The spinal surgery robot ‘CUVIS-spine’ that we have developed and manufactured with our technology has acquired FDA (US)’s licensing. This is the 3rd license that we have acquired, followed by Korea and Europe, and now we can sell our solution in all countries including the US which is the biggest medical market.” He also said that “CUREXO plans to focus on our medical robots sales, including ‘CUVIS-joint’, ‘CUVIS-spine’ and ‘Morning Walk’ to not only the Korean market but also to advanced medical markets such as the US and Europe.” “CUVIS-Spine had successfully carried out the insertion of pedicle screws on a patient with spinal stenosis and degenerative spondylolisthesis,” said Jae-Joon Lee, CEO of Curexo, following the first successful spinal robotic surgery at Severance Hospital (Sinchon, South Korea). “After the surgery, image examinations had proven the fixation of the screws as originally planned, and the patient was able to leave the hospital on the fifth day with improvements.” “I expect that Korean robots will be able to enter the market by accumulating track records and creating clinical evidence in the field of spinal surgical robots, which is expanding globally,” said Seong Yi, MD, of the department of neurosurgery at Severance Hospital, who participated in the development of CUVIS-Spine. “Clinical data of spinal surgical robots, including safety, validity, and radiation safety level will contribute to the development and globalization of the domestic surgical robot industry.” Pedicle screws 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

nodule individually. The process becomes even more difficult--and subjective--when the gland has multiple nodules.

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 screws and rods are no longer needed for stability and may be safely removed. However, most surgeons do not recommend removal unless the pedicle screws cause discomfort for the patient.

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RADIOLOGY AI MODEL

QA DEVICE FOR MR-LINACS

MULTIVIEW POSITIONING PLATFORM

PaxeraAI is an AI model designed to learn and improve its accuracy as it interacts with radiologists, using the latest machine-learning technology to monitor users’ behavioral patterns and adjust to their preferences.

Daily QA-MR is the first commercially available daily QA device for MR-linacs, enabling fast beam quality checks in the presence of magnetic fields. With Daily QA-MR, a single beam measurement supports four beam quality checks.

The Multiview Positioning Platform has been designed with feedback from a leading medical imaging facility and obtains multiple weight-bearing anatomical views. The platform helps to reduce patient movement and costly retakes.

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Preoperative Intranasal Insulin Curbs Postoperative Delirium

dministration of intranasal insulin before gastrointestinal (GI) surgery in elderly patients helps protect them against postoperative delirium (POD), according to a new study. Researchers at The General Hospital of Western Theater Command (GHWTC; Chengdu, China) and Fourth Military Medical University (FMMU; Xi’an, China; www. fmmu.edu.cn) conducted a randomized controlled study of 90 elderly patients undergoing laparoscopic radical GI tumor resection under general anesthesia. Patients were randomly divided into a control group (0.5 mL intranasal saline) or an insulin group (20 U/0.5 mL insulin administered intranasally) for two days prior to surgery, with 45 patients in each group. Incidence of delirium was measured at postoperative day one, three, and five.

The results showed that patients who received preoperative intranasal insulin were significantly less likely to develop POD within five days of surgery (12.5% versus 47.5%, respectively). The incidence of POD decreased in both groups over time, and was no longer significantly different on postoperative day five. In addition, repeated intranasal insulin administration before surgery was associated with reduced levels of several proinflammatory markers, including interleukin-6, tumor necrosis factor-alpha (TNF)-α, and interleukin-1-beta. The study was published on February 23, 2021, in American Journal of Geriatric Psychiatry. “Age is a key risk factor for postoperative delirium (POD), which may occur in up to 54% of elderly patients having surgery for GI cancer,” said corresponding author Gu Gong, MD, of GHWTC, in an email to

Reuters Health. “Nasal administration of insulin may reduce the incidence of postoperative delirium by increasing cerebral blood flow, reducing inflammation, improving sleep-wake cycle disorders, reducing tau protein hyperphosphorylation, and reducing amyloid-beta deposition.” Delirium is a serious postoperative complication with long-term sequelae for patients and families, including persistent cognitive dysfunction, increased hospital length of stay, and a higher mortality risk. Inflammation and hyperglycemia have been identified as contributing factors to postoperative delirium. On the other hand, insulin, a peptide hormone naturally produced by β cells of the pancreatic islets that is important for blood glucose metabolism, has been shown to decrease inflammation post-operatively.

Baxter to Acquire Hillrom, Eyeing Connected Care Thrust Worldwide

Cont’d from cover

well as accelerate its expansion into digital and connected care solutions. “Baxter and Hillrom share a common vision for transforming healthcare to better serve all patients and providers,” commented Baxter CEO, José (Joe) E. Almeida. “Patients increasingly want to receive their care at home or nearby, while hospitals and other care providers are increasingly using digital health technologies to expand access, improve quality and lower costs.” John Groetelaars, CEO of Hillrom, added, “Baxter is the ideal partner to enhance our global reach and realize the true potential of our vision to accelerate medical innovation around the world. With our shared patient-centric cultures, we look forward to seamlessly bringing our two companies together.”

Baxter expects the combination to result in approximately USD 250 million of annual pretax cost synergies by the end of year three, not including benefits of potential revenue growth resulting from the combination. Launched by Dr. Ralph Falk and Dr. Don Baxter in 1931 as the first commercial manufacturer of prepared IV solutions, and having grown to current annual sales of over USD 12 billion across 100 countries, as well as a stock market value in excess of USD 41 billion, Baxter International, Inc. (Deerfield, IL, USA; www.baxter.com) is a global healthcare powerhouse in technologies relating to critical care, nutrition, dialysis, surgery, and patient care. Baxter’s acquisitions in the past decade have included Baxa Corp, Sigma Infusion Pumps, Synovis Life Technologies, Sweden’s Gambro AB, Cheetah Medical, as well as the Recothrom and Preveleak units of

Mallinckrodt. Hillrom’s roots go back to Bill Hillenbrand’s revolutionizing the hospital bed field starting with 1929, as well as the introduction of the world’s first handheld direct-illuminating ophthalmoscope by Dr. Francis Welch and William Noah Allyn in 1915. Today, with annual sales of around USD 4 billion worldwide, Hill-Rom Holdings, Inc. (Chicago, IL, USA; www.hillrom.com) is an international medical technology leader in digital and connected care solutions and collaboration tools relating to smart bed systems, patient monitoring, respiratory health, and surgical procedures. As a result of an acquisition drive in recent years, the Hillrom group now incorporates a number of well-known international brands including Allen Medical, Liko, Mortara, Trumpf Medical, Voalte, Welch Allyn, Breathe Technologies, and Excel Medical. HospiMedica International August-September/2021

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New Ultrasound Scanner App Automatically Detects Body Anatomy

n advanced ultrasound scanner software app uses artificial intelligence (AI) and machine learning (ML) to instantly recognize human anatomy. The app, designed for the Clarius Mobile Health (Clarius; Burnaby, Canada; www.clarius.me) Clarius C3 HD multipurpose and Clarius PA HD phased array ultrasound systems, is ideally suited for emergency medical service (EMS), critical care, and primary care users, enabling them to quickly and accurately examine the abdomen, heart, lungs, bladder, and other important structures without needing time-consuming interaction. Users simply need to select Auto Preset AI and the Clarius app will automatically adjust settings to optimize imaging for the area being examined. In addition to Auto Preset AI, version 8.0 of the Clarius ultrasound app includes dozens of new features and enhancements, such as the ability to capture and document photographs taken with the mobile device camera (alongside the ultrasound images), providing context for education, reporting, and patient information. Users can also share interesting cases more easily to their social networks for commentary, as all images and clips remain anonymous to protect patient identity. Sharing also allows users to take advantage of native mobile device Integrations, such as Apple’s AirDrop. “Although machine learning and artificial intelligence have been applied to medical imaging over the past several years, this is the first commercially available application that enables an ultrasound system to recognize anatomy on a macro level, allowing the AI to recognize different structures in the human torso,” said Kris Dickie, vice president of research and development at Clarius. “We’ve labelled tens of thousands of ultrasound images within our vast database to achieve this exciting breakthrough, which will help clinicians to get the answers they need more rapidly.”

Medical Imaging

“Ultrasound is an amazing tool that gives those of us who know how to use it an instant window into the patient’s body,” said Oron Frenkel, MD, chairman of the Clarius medical advisory board. “Besides Auto Preset AI, which will set up novice users for success from day one, we now have nearly 100 ultrasound tutorials that can be viewed in-app. Through this integration, users can easily toggle between watching the video and scanning their patient. Clarius Classroom provides an excellent way to learn.” Clinicians are free to choose from ten wireless ultrasound scanners that are operated by the Clarius Ultrasound app, which can be downloaded from the Apple App Store or Google Play store for free. The app is compatible with most iOS and Android smart devices for high-definition (HD) imaging. Image: Clarius high-definition ultrasound scanners now enable clinicians to quickly examine the abdomen, heart, lungs, bladder, and other superficial structures (Photo courtesy of Clarius Mobile Health)

Ultrasound Accurately Diagnoses Tendon Injuries

ltrasound can accurately diagnose flexor tendon hand injuries while also being a fast, inexpensive, and potentially indispensable dynamic tool, claims a new study. Researchers at Ain Shams University (ASU; Cairo, Egypt; www.asu.edu. eg) conducted a cross-sectional prospective study that included 35 patients (18-58 years of age, 24 male) presenting at ASU between September 2018 and January 2020 with penetrating trauma to the volar aspect of the hand or wrist with questionable clinical findings, and were therefor candidates for exploratory surgery. All underwent pre-operative ultrasound to guide their management, with ultrasound results compared with the operative findings as the gold standard test. On ultrasound examination, 21 of the 50 injured tendons identifies were reported to have complete tears, and 10 tendons were partially torn. The most common cause of injury was cut wounds by sharp objects (20 cases), with injury by a knife as the highest incidence. The results showed that sonographic examination had 100% accuracy, sensitivity, and specificity, in diagnosing full-thickness tears as well as tenosynovitis of hand flexor tendons. The study was published on April 29, 20201, in Ultrasound in Medicine and Biology. “Ultrasound provides data on the extent of injury that effectively helps both set up an appropriate operative plan and predict the patient’s functional outcome post-operatively, which in turn will have a direct impact on the patient’s rehabilitation plan and lifestyle,” concluded lead author Chris Nabil Hanna Bekhet, MD, of the radiodiagnosis department, and colleagues. “Our study also helps anchor the notion that musculoskeletal ultrasound could be widely employed for soft tissue structures, with their well-recognized advantages compared with other imaging techniques.” Hand and wrist injuries make up 28% of all musculoskeletal injuries and account for 14-30% of all patients treated in the emergency department. Tendon injuries are the second most common of these injuries, with injury to flexor tendons having debilitating consequences and high rates of reoperation. Assessing hand injuries through clinical examination can overlook these tendon injuries, and surgeons sometimes opt for explorative surgical methods to detect them.

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INSTRUMENTATION SYSTEM

INFUSION PUMP SYSTEM

GLUCOSE/KETONE METER

The SmartLab with Insight software is a flexible system for measurement/analysis of respiratory signals in research. The base module can accept up to three sensor modules for measuring flow and pressures.

The BeneFusion 5 Series infusion pump system streamlines workflow via a 3.5" colored capacitive touchscreen, which features an intuitive UI for smooth operation. Fast preparation is made possible using SmartRapid technology.

The StatStrip Xpress2 Glucose/Ketone Meter is safe and effective for use in all hospital and professional healthcare settings including critical care, designed for applications that do not need data interfacing and connectivity

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Poor Iodine Status Impairs Fetal Neurological Development

new study warns that young women who adopt plant-based diets are at increased risk of having children born with impaired neurological conditions, due to poor iodine intake. Researchers at the University of South Australia (Adelaide, Australia; www.unisa. edu.au) conducted a study that compared 31 women consuming a strictly vegan/ plant-based diet to 26 women consuming omnivore diets, in order to determine iodine intake and excretion. All women reported two days of dietary intake, and also provided two urine samples to assess urinary iodine concentration (UIC). The results showed that mean UIC was significantly different among groups, at 44 µg/L in the vegan/plant-based women versus 64 µg/L in omnivores; both failed to meet the 100 µg/L level recommended by the World Health Organization (WHO). Iodine intake significantly differed among groups, at 78 µg/day in the vegan/plantbased group and 125 µg/day in the omni-

vores. Factors mentioned that affected iodine intake were a growing preference of Himalayan (pink) salt, which contains an insignificant level of iodine, over iodized table salt; a preference for plant-based milks that have low levels of iodine, and are not currently fortified; and a growing trend towards avoidance of fortified bread, fish and seafood (including seaweeds), eggs, and dairy foods. Both groups also failed to meet the estimated average requirement for calcium, selenium, and B12. The study was published on March 29, 2021, in the International Journal of Environmental Research and Public Health. “Mild to moderate iodine deficiency has been shown to affect language development, memory, and mental processing speeds. A 150mcg supplement is recommended prior to conception and throughout pregnancy,” said lead author research dietitian Jane Whitbread, APD. “Unfortunately, most women do not take iodine supplements before conceiving. It is important to consume adequate iodine, especially during the reproductive years.”

Iodine deficiency in pregnancy remains the leading cause of preventable retardation worldwide. Severe iodine deficiency during pregnancy can cause substantial mental impairment and delayed development in children, and even mild iodine deficiency during pregnancy is associated with children with lower IQs. But although Iodine is an essential trace element, it is not produced naturally in the body, and needs to be consumed, or fortified by supplementation.

Healthcare Ecosystem Unlocks Patient Monitoring Potential

Cont’d from cover

The Mindray Medical (Shenzen, China; www.mindray.com) M-Connect Universally Connected Platform provides a host of smart information technology (IT) tools and a universal centric monitoring platform to seamlessly integrate medical devices using a standard interface. Employing proprietary Mindray IoT (M-IoT) technology to obtain information on all connected medical equipment, M-Connect can provide data on equipment usage, statistical analysis, and outputs the distribution and usage of equipment in various departments in a graphical manner. The M-connect IT solution links the entire pre-hospital, intra-hospital, and inter-hospital

journey of each and every patient, for seamless transfers and faster remote guidance. It can optimize clinical workflow, improve efficiency, bring order to complicated tasks, help clinicians cope with the challenges they face, react more confidently to adverse events, and diagnose and treat patients more efficiently. Individual modules include solutions for the intensive care unit (ICU), operating room (OR), critical care unit (CCU), and emergency room (ER). “The intelligent world is arriving. 5G, artificial analysis, IoT, and other emerging technologies promise new possibilities, opportunities, and experiences for everyone, everywhere,” said Dr. Li Xinsheng, group vice president of

Mindray. “M-Connect is shaping the future, inspiring a new age of connection, and connecting patients with their medical providers. Together, we can leverage the benefits of technology for the healthcare industry.” The integration of complete data from all connected medical devices, such as continuous blood pressure (BP) analysis and 24-hour electrocardiogram (ECG) summary, also allows healthcare facilities to use the M-Connect Universally Connected Platform as a foundation for big data analytics on the entire system, as well as comprehensive analysis of patient data and implementation of targeted treatment strategies throughout the whole patient journey. HospiMedica International August-September/2021

Nociceptive Monitoring Technology Reduces Postoperative Pain

unique device that can monitor a patient’s sympathetic system response levels during surgery can help reduce postoperative pain. The Medasense (Ramat Gan, Israel; www.medasense.com) PMD-200 is designed to objectively monitor and quantify a patient’s pain response during a surgical procedure by means of artificial intelligence (AI) and a proprietary non-invasive probe that fits over the patient’s finger and incorporates four different multi-sensors. A nociception level (NOL) index score is derived from dozens of physiological parameters extracted from the data and displayed either on the stand-alone monitor or on a connected Philips IntelliVue patient monitor. A recent study from Leiden University Medical Center (LUMC, The Netherlands; www.lumc.nl) that explored the potential use of NOL monitoring to help enhance recovery after surgery found that pain scores were 33% lower when administration of pain medication during surgery was guided with NOL monitoring. Also, an economic analysis by Coreva Scientific (Königswinter, Germany; www.cor eva-scientific.com) found that these outcomes could enable a 22% reduction in healthcare costs associated with acute postoperative pain treatments, pain-related readmissions, and emergency room visits. “Medical technology should always aim to achieve the two core goals that justify adoption in the market: improved patient care and cost savings,” said Mira Sofer, VP of business development and mar-

Stroke Recovery Device Facilitates Muscle Reeducation

keting at Medasense. “Recent NOL studies and the economic analysis conducted by Coreva Scientific emphasize the benefit of preferring NOL monitoring over current standard of care, for better patient outcomes and lowering healthcare expenditures.” Activation of the sympathetic nervous system, as a result of multiple stimuli and inputs, leads to a constellation of nociception-related physiological responses, with complex inter-associations and different response profiles. Recognizing the complex nature of this process, the NOL index serves as a composite quantifier of autonomic signals. Image: An intraoperative monitor can help reduce subsequent pain (Photo courtesy of Medasense)

brain-computer-interface (BCI) system assists functional rehabilitation in stroke patients with upper extremity disability. The Neurolutions (Santa Cruz, CA, USA; www.neurolu tions.com) IpsiHand system is designed to leverage the uninjured (ipsilateral) side of the brain to improve arm and hand function by harnessing BCI. The system includes a lightweight, adjustable, battery-powered, robotic exoskeleton that physically opens and closes the patient’s hand in response to the patient’s thoughts; a wireless electroencephalography (EEG) biometric headset that measure the patient’s brain signals; and a tablet application that guides the patient through the therapy session and provides for seamless upload of usage and performance data to the cloud. IpsiHand uses non-invasive EEG electrodes--instead of an implanted electrode or other invasive feature--to record brain activity. EEG data is then wirelessly conveyed to the tablet for to determine the patient’s intent to move their affected hand, and analysis of the intended movement. These signals are translated into motor movement signals of the robotic skeleton hand brace, resulting in opening and closing of the impaired hand, wrist, and arm, helping stroke patients improve grasping. The device should not be used by patients with severe spasticity or rigid contractures that can prevent the electronic hand brace from being properly fit or positioned. “A person whose left hand and arm are paralyzed has sustained damage to the motor areas on the right side of the brain. But the left side of the person’s brain is frequently intact,” said neurosurgeon Eric Leuthardt, MD, founder and chief scientific officer of Neurolutions. “The idea is that if you can couple those motor signals that are associated with moving the same-sided limb with the actual movements of the hand, new connections will be made in your brain that allow the uninjured areas of your brain to take over control of the paralyzed hand.” Although stroke occurs in the brain, it affects the entire body and can cause long-term disability, such as complete paralysis of one side of the body (hemiplegia) or one-sided weakness (hemiparesis). Stroke survivors may have problems with the simplest of daily activities, including speaking, walking, dressing, eating, and using the bathroom. Intensive, repeated, and long-term rehabilitation training are critical for enhancing the physical mobility of stroke patients, helping to alleviate post-stroke symptoms.

HospiMedica International August-September/2021

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PATIENT MONITOR

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Single-Use Bronchoscope Line Expands Critical Care Flexibility

ive new premium disposable endoscopes extend physician’s choices in diagnostic and therapeutic proce-

dures. The Olympus (Tokyo, Japan; www.olym pus-global.com) Single-Use H-SteriScope portfolio includes five bronchoscopes that range from the Zero to Extra sizes, with an outer diameter range of 2.2-6.2 mm and a working channel range of 1.2-3.2 mm. Common features include an operator controlled insertion tube rotation of up to 90 degrees (left and right) to support easy insertion and positioning of the endoscopic devices, and a tip angulation range of 210 degrees (up and down) to facilitate access to targets within the tracheal-bron-

Cont’d from cover

chial tree. Delivered in sterile-packaging, the H-SteriScopes are ready for use whenever needed, and never require reprocessing or repair. The diversity of the portfolio was specifically designed to assist tissue biopsy, foreign body retrieval, and other advanced lung procedures, and to help clinicians target, diagnose, and treat patients by maximizing workflow and productivity. The Olympus Single-Use H-SteriScopes are made by Hunan Vathin Medical Instrument (Xiangtan; China www.vathin.com). “We are very excited to launch our first line of single-use bronchoscopes. These premium disposable bronchoscopes give physicians flexibility and choice when convenience and

portability are critical factors in care,” said Lynn Ray, vice president and general manager of the global respiratory business unit at Olympus. “Adding them to our already robust bronchoscopy portfolio aids physicians in achieving faster transitions to diagnosis and treatment for patients.” “With the launch of the H-SteriScopes, Olympus is entering the single-use endoscopy market and ushering in a new era in endoscopy where single-use and traditional scopes are seen together as part of a complete and complementary endoscopy portfolio,” said Ken Daignault, vice president of strategy and development of the single-use endoscopy unit at Olympus.

Robotic Platform Precisely Steers Surgical Catheters

electromagnet attached to a six degree-of-freedom (DoF) collaborative robot manipulator arm that magnetically steers a catheter with submillimeter precision. Guidance is provided via externally-generated electromagnetic fields that generate co-directional, prescribed magnetic fields and forces with independently controlled magnitudes. Two serial-link manipulators use an interface to communicate with their own embedded controllers in order to execute the movement of the manipulators upon receiving a pose command, expressed as a set of joint velocities. The effective workspace of the system can be approximated by a sphere with a radius of 783 mm; as the coil is positioned outside the human body, the catheter is always located between 50 mm and 200 mm away. The actuated instrument itself is a commercial coronary guide catheter that is gripped between a gear and bearing structure, with a maximum speed of 12 mm/s.

Once the user defines a catheter target at a known offset, the via-points for both the catheter and transducer are calculated from ultrasound images, with the anatomical parts of interest masked and converted to a point-cloud dataset. To sustain proper insertion control, the catheter tip is tracked via an ultrasound- based matching algorithm. In a phantom model, autonomous catheter insertion achieved a 100% success rate, with an average error between the tracked catheter tip and target positions of 2.09 mm, and a median procedure time of 32.6 seconds. “I believe that by having an ARMM platform in every hospital, we can transform diagnostic and therapeutic catheterizations. We now just have to work towards clinical trials and advance it from this translational stage,” said ARMM developer Christoff Heunis, MSc, who developed the system as part of his PhD thesis. A typical endovascular intervention would involve the insertion of a catheter in the groin

to access the heart or important arterial branches. The catheter is, in most cases, tracked by utilizing X-ray imaging facilitated by the injection of contrast material, which discriminates the catheter from the arterial tree. Despite its convenience, X-ray imaging causes additional safety risks due to the prolonged exposure of both patients and clinicians to ionizing radiation. Image: Christoff Heunis and the ARMM system (Photo courtesy of Christoff Heunis) HospiMedica International August-September/2021

Innovative Approach Treats Recurrent Tracheaesophageal Fistulas

new study shows how an innovative surgical approach called posterior tracheopexy can help treat recurrent tracheaesophageal fistulas (TEFs). Developed at Boston Children’s Hospital (BCH; MA, USA; www. childrenshospital.org), the procedure involves dividing the TEF, repairing the esophagus and trachea, and suturing the posterior membranous section of the patient’s trachea to the anterior longitudinal ligament of the spine. The esophagus is also rotated into the right chest cavity, known as rotational esophagoplasty. As a result, both the esophageal and tracheal suture lines are separated, which eliminates the risk of re-recurrence by avoiding the need to interpose tissue or prosthetic mesh between the suture lines. For the study, the researchers conducted a retrospective review of 62 patients with recurrent TEF, who were surgically treated with the posterior tracheopexy/rotational esophagoplasty at a median age of 14 months. All had significant respiratory symptoms, and 24 had earlier failed endoscopic and/or surgical attempts at repair. Results showed that postoperative morbidity included three esophageal leaks and one transient vocal cord dysfunction. No recurrences were identified at median follow-up of 2.5 years, and all symptoms were resolved. The study was published in the May 2021 issue of JACS. “By performing a posterior tracheopexy after the division and repair of the recurrent TEF, we take advantage of the child’s own tissue and nearby structural support provided by the spine to completely separate the suture lines,” said study co-lead author Benjamin Zendejas-Mummert, MD, of BCH. “In a field where re-recurrence of recurrent TEF has been common, the emergence of a procedure with a zero-percent recurrence rate and minimal morbidity is a game-changer.” A TEF is a congenital defect in which an abnormal connection forms between a child’s esophagus and trachea; it often occurs concomitant with esophageal atresia. Even after surgical repair, TEFs recur in about 10-15% of infants and children. They rarely close spontaneously, and typically require surgical or endoscopic intervention.

Experienced Cardiologists Can Perform Stroke Thrombectomy

ardiologists with proficiency in cardiac interventions can competently perform stroke thrombectomy after a short period of training, according to a new study. Researchers at University Hospital Kralovske Vinohrady (FNKV; Prague, Czech Republic; www.fnkv.cz) conducted a retrospective study that analyzed the learning curve effect when FNKV established a new stroke thrombectomy program in the existing cardiac catheterization lab in 2012, in close cooperation with neurologists and radiologists. The decision to perform catheter-based thrombectomy in the 333 patients was made by a neurologist, based on acute stroke clinical symptoms and CT angiographic findings. The primary endpoint was functional neurological outcome, per Modified Rankin Scale (mRS) score at three months. The results revealed that clinical mRS outcomes did not vary significantly across years (2012 to 2019). Symptomatic intracerebral hemorrhage occurred in 19 patients (5.7%), and embolization in a new vascular territory occurred in six patients (1.8%), outcomes that are similar to those of established neuroradiology centers. In addition, the desired clinical results were achieved from the onset of the program, after the cardiologists were trained by an interventional radiologist on the thrombectomy procedure. The study was published on April 12, 2021, in JACC: Cardiovascular Interventions. “There are not enough neuro-interventionalists in Europe. Interventional cardiologists can perform thousands of procedures every year, Cont’d on page 20

HospiMedica International August-September/2021

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Flow Diversion Embolization Device Reduces Thrombogenicity

proven flow diverter now features breakthrough biomaterial technology that modifies the implant surface to improve hemocompatibility. The Medtronic (Dublin, Ireland; www. medtronic.com) Pipeline Flex embolization device, developed 10 years ago, now includes Shield Technology, a modification of the surface implant in which a synthetic phosphorylcholine (PC) polymer is covalently-chemically-bonded to the strands of the device braid. The inert polymer mimics the outer membrane of a human red blood cell (RBC), so that other blood cells do not react to the braided cylindrical mesh tube. “In addition to addressing material thrombogenicity, Shield Technology improves device performance by reducing the force required for both delivery and resheathing of the device,” said Dan Volz, president of the neurovascular business at Medtronic. “We believe that Shield Technology opens up a new range of options for physicians to continue to achieve improved patient outcomes, and

we continue to challenge ourselves to deliver solutions that improve outcomes and increase value for all healthcare stakeholders.” The third generation Pipeline Flex embolization device is designed to be placed in a parent vessel across the neck of an intracranial aneurysm (IA). Made of 48 braids, 36 of which are cobalt-chromium (CoCr) and 12 platinum wires for radiopacity, the implant provides approximately 30% metal coverage of the arterial wall surface area. In recent studies, Pipeline Flex with Shield Technology showed a strong record of safety and efficacy, with 77.2% complete aneurysm occlusion at 12 months, a 3.2% primary safety endpoint, and 93.1% complete wall apposition post-procedure. Wide-neck IAs are defined as having a neck greater or equal to four mm, or a dome-to-neck ratio of less than two. They are often untreatable by surgical clipping, as many wide- neck aneurysms are in vessels deep within the brain that are not amendable to being treated by open brain surgery. Sufficiently dense coil packing of

the AI to permanently exclude blood flow is also difficult to achieve. Flow diversion, on the other hand, is an endovascular technique whereby instead of placing a device inside the aneurysm sac, it is placed in the parent blood vessel to divert blood flow away from the aneurysm itself. Image: The Pipeline Flex embolization device with Shield Technology (Photo courtesy of Medtronic)

Experienced Cardiologists Can Perform Stroke Thrombectomy cont’d from page 19

whereas a neuro-interventionalist will at best perform hundreds a year. It is quicker and simpler to train the cardiologist to do it,” said senior author Petr Widimsky, MD. “The cath lab is open 24/7, but if we only have one neuro-interventionalist, we cannot offer a 24/7 service for stroke thrombectomy. But if we merge with cardiology then we can.” “Interventional cardiologists are used to performing carotid and coronary artery stent-

ing; the thrombectomy procedure is different to coronary angioplasty, but it is not more difficult. Actually, I think coronary angioplasty can be more difficult,” concluded Dr. Widimsky. “I think interventional cardiologists can learn what they need to know in about six months. I would recommend they should watch about 50 procedures and perform at least 25 under supervision.” “To be able to guarantee optimized stroke therapy as soon as possible, disputes over

competence among the individual medical societies involved must be ended,” added Marius Hornung, MD, and Horst Sievert, MD, of CardioVascular Center Frankfurt (Germany), in an accompanying editorial. They advocate the creation of interdisciplinary teams and appropriately trained and experienced physicians, regardless of their specialties, to perform rapid acute stroke interventions and endovascular thrombectomy. HospiMedica International August-September/2021

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Surgical Techniques

Laparoscopic Wiper Maintains Perfectly Clear Visual Field

novel device allows a surgeon to clean a laparoscope of fat, condensation, blood, and other surgical debris without removing it from the patient’s body. The ClearCam (Austin, TX, USA; www.clearcam-med.com) Kelling device is an in-vivo laparoscopic lens wiper intended to clear the intra-operative view of the surgical site during minimally invasive surgery by physically removing debris, blood, and bodily fluids from the laparoscope lens. The device consists of a sheath and a handle that slides over the laparoscope in seconds. The handle contains a wire connected to a blade wiper at the distal end of the sheath made of over-molded medical-grade silicon that provides smooth lens contact, and a simple easy-to-use lever control. The Kelling, available in 5 and 10 mm angled and flat versions, does not require a trocar, as the outer sheath allows access into the abdominal cavity. The sleeve can also accept additional instrumentation, including graspers, scissors, and ligating instruments. The mechanical, disposable device eliminates the need to remove the laparoscope from the body cavity for lens cleaning, improving safety for the patient, surgeon, and surgical staff; in addition, it saves procedure time. To clear the laparoscope lens, the wheel shaped actuator

Cont’d from cover

is rotated for a precise wipe. “ClearCam is passionate about introducing more efficient and productive surgeries, with few abdominal surgical procedures today evading the laparoscopic approach,” said John Uecker, MD, CEO of ClearCam. “A good surgeon is a surgeon that isn’t frustrated by poor vision due to a blurred scope. Our dedicated process of identifying opportunities to perfect the laparoscopic process has paid off, to allow surgeons to use Kelling effectively and successfully, without cleaning interruptions.” Image: The swift tip of the Kelling device wipes clean the laparoscopic lens (Photo courtesy of ClearCam)

SBRT Can Treat Multiple Metastatic Tumors

of Chicago Comprehensive Cancer Center (IL, USA; www.uchicago medicine.org/cancer), the University of Michigan (U-M; Ann Arbor, USA; www.umich.edu), and other institutions conducted a study involving 39 patients (mean age, 63.1; 20 57.1% male; 85.7% White) with breast, prostate, or non-small cell lung cancer (NSCLC), with at least three metastases or two metastases in close proximity. In all, 34.3% had breast cancer, 28.6% had NSCLC, and 37.1% had prostate cancer. Dose levels were considered safe if dose-limiting toxicity (DLT) levels were observed in no more than one of six patients per location; otherwise, the dose at that location would be de-escalated. The primary end point was DLT related to SBRT within 180 days of treatment. Results of the phase one study showed that at the end of the trial period, primary six-month DLT endpoint was 0%, indicating that the approach was safe enough to begin phase 2/3 clinical trials in a larger group of patients. The study was published on April 22, 2021, in JAMA Oncology. “People have been saying for years that if we used SBRT in patients with multiple, limited metastases, we could potentially cure more patients. But it’s very technically complicated to do so,” said lead author Professor Steven Chmura, MD, PhD, of the University of Chicago. “The greatest challenge was having a whole team of people come together and figure out how we could define the doses and manage the real-time quality assurance to make sure every single patient had the best treatment possible.” SBRT is emerging as an attractive option for treating cancers in the lung, head and neck, prostate, liver and other disease sites, with the ob-

jective of increasing local control of the target lesion while limiting dose to nearby critical structures and normal tissue. Requirements include precise localization of the target lesion in the treatment planning process; accounting for tumor motion due to respiration or other changes in the body; highly conformal dose distribution to the target volume, including a steep dose gradient to minimize radiation to surrounding healthy tissue; and image-guidance at the time of dose delivery for verification and adjustment of the target localization. Image: SBRT can be used to treat multiple metastases (Photo courtesy of University of Chicago)

Hysterosalpingo Contrast Sonography Helps Infertility Exams

Cont’d from page 12

The results showed that out of the 13 fallopian tubes examined, nine were obstructed, with one false positive and three true negatives. When compared to HSG, HyCoSy showed a sensitivity of 100%, a specificity of 75%, positive predictive value of 90%, a negative predictive value of 100%, and an accuracy of 92.3%. The study was presented at the virtual annual meeting of the American Roentgen Ray Society (ARRS), held during April 2021. “HyCoSy with a microbubble contrast shows promise and may obviate the need for HSG, particularly in straightforward cases. In a majority of cases not studied with HSG, free spill was obvious and imaging was straightforward, so HSG was not considered necessary,” said lead author

HospiMedica International August-September/2021

and study presenter Shuchi Rodgers, PhD. “Most importantly, we were able to immediately follow pelvic ultrasound and sonohysterography on the same day, as opposed to HSG, which often occurs on a different day.” HyCoSyis an ultrasound technique developed to assess whether the fallopian tubes are open or blocked by injecting a fluid/bubble mix containing normal saline mixed with air, or ExEm foam gel. HSG is a similar procedure, but it uses x-ray fluoroscopy to examine the uterus and fallopian tubes. First carried out in 1917, the procedure is also used to investigate miscarriages resulting from abnormalities within the uterus and to determine the presence and severity of tumor masses, adhesions, and uterine fibroids.

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The EuroVac H-40 surgical suction pump is a electric, high-vacuum and high-flow suction pump designed as a suction device for operation rooms where a high-suction capability and a rapid response is required.

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The DUB-100 ultra electro surgical unit is designed for cutting, bipolar, ultrasonic coagulation of biological tissues. The device can be used for laparoscopic and open surgical procedures, including ultrasound surgery.

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AI-Powered Imaging Software Aids Coronary Stenting

new imaging platform merges optical coherence tomography (OCT) with artificial intelligence (AI) for enhanced visualization of calcium-based blockages. The Abbott Laboratories (Abbot Park, IL, USA; www.abbott.com) OCT technology uses near-infrared (NIR) light and the Dragonfly OpStar imaging catheter to provide high-definition (HD) images from within a blood vessel, improving physicians’ assessment of blockages in those vessels and optimizing decisions related to stent selection, placement, and deployment. The system is powered by Ultreon 1.0 Software to automatically detect degree and thickness of calcification, highlight calcification arc and maximal thickness, display calcification angle and thickness values throughout pullback in real-time, and highlight calcification overlays on the vessel with co-registration views. In addition, it can automatically detect external elastic lamina (EEL) and lumen to help identify landing zones for accurate stent placement; provide vessel diameter measurements;

facilitate measuring of lesion length and identification of optimal user-adjusted stent landing zones; aid stent length selection through co-registration; provide side-by-side viewing of live and co-registered angio to help physicians guide precise stent deployment; and ensure optimal stent expansion and apposition by instantaneous display of expansion and apposition results. “Increased adoption of OCT imaging, when combined with advanced technology like AI, allows cardiologists to have a more precise and measurable way of supporting patients undergoing coronary stent procedures,” said Nick West, MD, chief medical officer and divisional vice president of global medical affairs at Abbott’s vascular business. “Ultreon Software can potentially improve physician and patient experience by utilizing a systematic process, reducing variability and increasing accuracy of diagnosis and application of therapies.” “Ultreon’s customizable user interface and AI detection will make decision-making faster and reduce procedural variability, especially

for the increasing number of physicians who are learning to utilize OCT imaging over other more traditional imaging technologies,” said Jose Mª de la Torre Hernández, MD, head of interventional cardiology at Hospital Universitario Marques de Valdecilla (Santander, Spain). “The automatic display of details with Ultreon reduces uncertainty during the preparation for stent placement and allows for increased accuracy to help us deliver better care to our patients.” Image: OCT and Ultreon Software image calcium deposits in blood vessels (Photo courtesy of Abbott)

Power Tool Conversion Helps Stabilize Skeletal Fractures

new kit that includes single-use pre-sterilized covers for commercial power tools improves skeletal traction procedure efficiency while maintaining sterility. The Arbutus Medical (Vancouver, Canada; www.arbutusmedical.com) SteriTrak kit includes a specialized pin, a pre-sterilized cover, and a converted DeWalt (Leola, PA, USA; www.dewalt.com) drill, with the drill, batteries, and a charger added at no cost. The drill includes a redesigned chuck for the traction pin, with easy click-in insertion at any angle. A sliding plastic guide provides positional control of the 22X310 mm K-Wire pin, which accommodates all patient sizes. The single-use designation removes the need to autoclave the

power tool, which can be stored in the emergency room (ER) with no need for additional sterilizing. “We’ve spent years innovating power tools for orthopedics, creating a sterilizable cover to allow affordable hardware tools to be used in a sterile environment for surgeries around the world. In the past year, we found a new application for our expertise – driving pins for skeletal traction procedures outside of the operating room,” said Lawrence Buchan, CEO of Arbutus Medical. “Our new SteriTrak kit allows the emergency room to have sterile tools for skeletal traction readily accessible when time is critical. Bone fractures are a traumatic event, but with SteriTrak, you can now apply temporary traction in about one minute.”

“ERs need a drill for skeletal traction, but most don’t have access due to complexity of reprocessing power tools from the operating room,” concluded Mr. Buchan. “About 75% of US Level I and Level II trauma centers perform Cont’d on page 23 HospiMedica International August-September/2021

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Surgical Techniques

New Stapling Technology Promotes Sleeve Gastrectomy

ovel stapling technology offers surgeons performing sleeve gastrectomy procedures a continuous staple cutline of 23 centimeters. The Standard Bariatrics (Cincinnati, OH, USA; www.standardbariatrics.com) Titan SGS is a single patient use, sterile instrument supplied preloaded with staples that is designed for cutting and stapling gastric tissue during sleeve gastrectomy pouch creation. The device is comprised of the stapler itself, located in the sterile field; the handle, which does not contact the patient and is handled by the user within the sterile field; and the shaft and end effector. The staples themselves are housed in the end effector until they are applied to the tissue where they are permanently implanted. The stapler end effector is 230 mm long and contains 342 ‘B’ shape staples organized in six staggered rows, three on each side of the cut line, to ensure consistent staple formation, improved staple-line strength, and fewer malformed staples, resulting in a more secure staple line and fewer leaks under high burst pressures. As with other powered staplers, the Titan SGS opens and closes through a simple mechanical linkage in the shaft and end effector. Additional features provide real-time audio and visual feedback, graduated staple height formation, tissue-sensing technology, and a firing cycle optimized for gastric tissue. “We are focused on bringing innovation and breakthroughs in science and surgery to our users,” said Matt Sokany, CEO of Standard Bariatrics. “We believe Titan SGS has the potential to overcome the challenges bariatric surgeons may encounter with the use of existing short-cartridge stapling technology.” Sleeve gastrectomy is a restrictive form of weight loss surgery intended for the morbidly obese which reduces the size of the stomach by removing the lateral 2/3 with a stapler; the stomach is drastically reduced in

size, but function is preserved, with no malabsorption of nutrients and supplements. The procedure avoids problems associated with bypass bariatric procedures, including anemia, intestinal obstruction or blockage, osteoporosis, and protein and vitamin deficiency, and since about 100-200 ml of stomach capacity is maintained, there are few restrictions on food consumption. Image: The Titan SGS provides a continuous staple cutline of 23 centimeters (Photo courtesy of Standard Bariatrics)

Power Tool Conversion Helps Stabilize Skeletal Fractures cont’d from page 22

more than 175 skeletal traction procedures annually, but more than 90% of trauma center ERs don’t have a drill for their own use. The SteriTrak kit will simplify how skeletal traction is performed in the ER by maximizing efficiency, and that’s really important, because this is a setting where every second counts.” Skeletal traction is most often used for temporary stabilization, if a delay in operative treatment is expected to be greater than 12-24 hours. Traction through the distal femur is most common, with traction through the proximal tibia used provided there are no ligamentous knee injuries.

HospiMedica International August-September/2021

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FULL HD 3D SURGERY CAMERA

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New Surgical Staples Enhance Patient Outcomes

esign innovations and an expansive range of sizes provide surgeons with more options for surgical stapling. Medline (Mundelein, IL, USA; www.med line.com) UNBITE REFLEX Nitinol staples feature an ultra-low profile, wide bridge design to enhance stability, while helping to minimize soft tissue irritation. The staples are designed with a slightly curved bridge to provide even compression across the osteotomy or fusion site, with reinforced shoulders that help to improve strength in the highest strain area of the implant. The staples are available in several sizes and their corresponding options: Mini - 8 x 8mm, 10 x 10mm, 12 x 12mm Max - : 15 x 15mm, 15 x 18mm, 18 x 18mm, 18 x 20mm, 20 x 20mm Ultra - : 20 x 20mm, 25 x 20mm An ergonomically designed adjustable inserter allows the surgeon to expand and contract the implant’s legs for easy insertion. The

MAQUET CRITICAL CARE

inserter also features an elevator tip design that aids in implant removal and reinsertion. The Mini staple system includes a stepped saw blade allowing for a single pass for more reproducible closing wedge. “The Medline UNITE foot and ankle team is laser-focused on developing specialty implant systems that enhance surgical techniques and improve patient outcomes. To help us create the new Reflex staple system, we leveraged expertise from several fellowship-trained foot & ankle surgeons,” said Scott Goldstein, director of marketing at Medline UNITE Foot & Ankle at the American College of Foot and Ankle Surgeons (ACFAS) scientific conference, held during May 2021 in Las Vegas (NV, USA). “The ACFAS annual scientific conference is an opportunity to interact with leading experts in the field and gain key insights that will allow us to continue developing innovations that address their unmet needs.”

Image: The Reflex nitinol staple system (Photo courtesy of Medline)

Disposable Endoscopy System Prevents Cross-Infection Risk new gastrointestinal (GI) endoscope platform helps eliminate potential infections in vulnerable hospitalized

patients. The EndoFresh (Shenzen, China; www. endofresh.com) Disposable Digestive Endoscopy System is comprised of a single-use disposable upper gastrointestinal (GI) endoscope observation, diagnosis, and treatment of the adult upper GI tract; a single-use disposable colonoscope for e observation, diagnosis, and treatment of the adult lower digestive tract (including the anus, rectum, colon, and ileocecal segment); and a disposable camera system that clicks into both scopes to provides 1920X1080 pixel visualization. A display monitor is not included in the system. The disposable electronic flexible endo-

scopes can bend up, down, left, and right in angles of up to 160° to it gives all-round observation angle of over 360°. Two light emitting diode (LED) lamps provide illumination for endoscopic video diagnosis, treatment, and observation. Auxiliary water and lens-washing capabilities ensure clear vision throughout endoscopy. The camera video processing system provides only white light imaging mode, and apart from the image processing functions, it also provides power supply to the endoscopes. “EndoFresh’s industry-pioneering technology addresses the traditional challenge of expanding endoscopy procedures, while ensuring its single-use devices are cost-effective, risk-controllable and accessible,” said Dr. Lee, CEO of EndoFresh. “With

this novel system, medical practitioners could offer patients a secure experience. It helps to prevent the risk of cross-infection and minimize the workload in preoperative screening and postoperative disinfection.” Inadequate reprocessing of endoscopes between patients can result in the retention of blood, tissue, and other biological debris, which can allow microbes to survive the disinfection or sterilization process. This debris can allow microbes to survive the disinfection or sterilization process, which could then lead to health care-associated infections (HAIs). Inadequate reprocessing can also result tissue irritation from residual reprocessing materials, such as chemical disinfectants. HospiMedica International August-September/2021

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Industry News

BD Seeks to Transform Patient Experience Through Vision of ‘One-Stick Hospital Stay’

ecton, Dickinson and Company (BD Franklin Lakes, NJ, USA; www. bd.com) has taken a large step forward in transforming the patient experience through a vision of a “One-Stick Hospital Stay,” building on its history of innovation and leadership in blood collection and vascular access solutions. For more than 70 years, BD has advanced the science of specimen collection helping to transform the blood collection process, making it safer and more comfortable for patients and clinicians, through the BD Vacutainer family of products. At the same time, the company’s comprehensive vascular access management solutions help clinicians choose the right device for the right patient to achieve “first-stick success” for starting IV lines while also reducing IV complications and extending catheter dwell times through proper IV care and maintenance, which may result in improved clinical outcomes and better patient experiences through fewer needlesticks. With its recent acquisition of Velano Vascular

and its innovative, needle-free technology that enables high-quality blood draws from existing peripheral intravenous catheter (PIVC) lines, BD can now enable health care providers to help eliminate multiple needlesticks for blood sample collection, reducing the pain and discomfort from the process while delivering quality outcomes and increased patient satisfaction. The addition of Velano Vascular’s FDA-cleared PIVO device allows BD to help health care providers move closer to the aspirational vision of the “One-Stick Hospital Stay,” where certain low-acuity patients will only have one “stick” for their entire hospital stay. “As a global leader in vascular access solutions and blood collection, BD has been on the forefront of innovations that improve the patient experience and reduce additional needlesticks,” said Rick Byrd, president of Medication Delivery Solutions for BD. “Now, with the addition of Velano and its groundbreaking technologies, we can envision a world where a ‘One-Stick Hospi-

tal Stay’ could be a reality for many by making the numerous inpatient blood draws better for everyone.” “Since inception, we have long championed a more compassionate vision for quality vascular care for every patient in every hospital anywhere in the world,” said Eric M. Stone, co-founder of Velano Vascular. “By joining forces with BD, we can collectively accelerate the impact of our work to more rapidly make this shared vision of a ‘OneStick Hospital Stay’ a reality.”

Smart Hospital Market to Exceed USD 220 Billion by 2030 Thanks to AI, ML, IoT

he global smart hospitals market is expected to reach USD 221.3 billion by the end of 2030 due to health professionals increasing their usage of electronic health records and connected medical assistance. Such digital technologies are increasing the availability of safe, effective, and patient-centric care services in hospitals. Clinical and administrative services are becoming more personalized and precise. These are the latest findings of Transparency Market Research (Albany, NY, USA; www.research andmarkets.com), a provider of custom market research services. The high prevalence of active COVID-19 (coronavirus) cases in the US, India, Brazil, and Russia has triggered innovations in humanoid robots. Even though the idea of humanoid robots felt like a distant possibility, the coronavirus pandemic made it a reality since these robots are capable of cleaning & disinfection activities, measuring a patient’s temperature and deliver medicines. Companies in the smart hospitals market are increasing their R&D to innovate in humanoid robots, as these machines hold promising potentials to offset the losses made in 2020. Healthcare facilities looking to eliminate costs associated with human staff are showing interest in humanoid robots. Technological enablement, automation, and digitization are impacting the smart hospitals market in a profound ways. Hospitals are transitioning from mere implementation of new technologies to adopting comprehensive strategies to scale business opportunities. As such, the concept of smart infrastructure is growing popular in the smart hospitals market. This involves the proliferation of artificial intelligence (AI), Big Data, and the IoT (Internet of Things) to create more integrated and efficient hospital spaces that suit the needs of clinicians and other occupants. Smart hospitals are improving care delivery on the global level. Connected technologies are making it possible for patients to consult doctors from any part of the world. This has led to the business model of telemedicine, which is predicted to grow exponentially. Electronic health records and clinical workflow applications are anticipated to hold the lion’s share in terms of revenue of the smart hospitals market. This explains why Big Data is improving service planning and clinical decision making in hospitals. As such, machine learning (ML) is emerging as a solution to manage huge volumes of healthcare data. The healthcare industry’s next technological revolution holds lucrative opportunities in the exploitation of an unprecedented amount of data combined with cloud computing services. Companies in the smart hospitals market are increasing their focus in ML, AI, and IoT, which offer expert insights about the future of digital healthcare. As such, data analytics and AI are expected to improve medical outcomes. However, hospitals face several hurdles in accomplishing their smart hospital initiatives. For instance, lack of management buy-in can be de-mo-

HospiMedica International August-September/2021

tivating for stakeholders. A bureaucratized and hierarchical management may show resistance in being adaptive and agile toward smart hospital initiatives, such as setting up connected medical imaging facilities or establishing the IoT in remote medical management. In order to overcome these challenges, consultancy companies in the smart hospitals market should help stakeholders to execute their initiatives in a comprehensive way by increasing emphasis on real business use cases.

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