Data bolsters case for Boston Scientific’s Emblem S-ICD and Watchman Flx devicesBoston Scientific Corp. reported positive results for its Emblem subcutaneous implantable defibrillator (S-ICD) system and next-generation Watchman Flx left atrial appendage closure (LAAC) device at the Heart Rhythm Society scientific sessions, which were online only this year due to the COVID-19 pandemic. Data from the UNTOUCHED and PRAETORIAN studies of the Emblem S-ICD demonstrated an inappropriate shock-free rate of more than 95% and affirmed it as a preferred option for most ICD-indicated patients who don t need a pacemaker. The PINNACLE FLX IDE trial showed the Watchman Flx to be a safe and effective alternative to oral anticoagulation therapies in reducing stroke risk in patients with nonvalvular atrial fibrillation. Data bolsters case for Boston Scientific’s Emblem S-ICD and Watchman Flx devicesBoston Scientific Corp. reported positive results for its Emblem subcutaneous implantable defibrillator (S-ICD) system and next-generation Watchman Flx left atrial appendage closure (LAAC) device at the Heart Rhythm Society scientific sessions, which were online only this year due to the COVID-19 pandemic. Data from the UNTOUCHED and PRAETORIAN studies of the Emblem S-ICD demonstrated an inappropriate shock-free rate of more than 95% and affirmed it as a preferred option for most ICD-indicated patients who don t need a pacemaker. The PINNACLE FLX IDE trial showed the Watchman Flx to be a safe and effective alternative to oral anticoagulation therapies in reducing stroke risk in patients with nonvalvular atrial fibrillation. FTC active in litigation over advertising, promotional claims during pandemicThe U.S. FDA s enforcement regarding products related to the COVID-19 pandemic has picked up steam recently, but the U.S. Federal trade commission (FTC) is also involved in this enforcement arena. Leonard Gordon, a partner at Venable LLP s New York office, told BioWorld that while the FTC and FDA missions seem to overlap, the FTC primarily targets unsupportable advertising claims rather than product labeling, a particularly relevant area in the COVID-19 pandemic. Biointellisense continues efforts to fight COVID-19 with BiobuttonDenver-based Biointellisense Inc. has unveiled Biobutton, a coin-sized, disposable medical device that measures continuous temperature and other vital signs for 90 days. The device, coupled with HIPAA-compliant data services, permits remote data capture and continuous multiparameter monitoring of temperature, respiratory rate and heart rate at rest, body position, sleep and activity state. New solid tumor diagnostic technique shown to improve mutation burden scoringLONDON A new technique for analyzing solid tumor DNA has been shown to significantly improve scoring of mutation burden, making it possible to identify patients who will respond to immunotherapy. Limbix raises $9M in series A funding for depression digital therapy for adolescentsPalo Alto, Calif.-based Limbix Health Inc. secured $9 million in series A funding for development of Spark, its prescription digital therapeutic (PDT) designed to treat depression in adolescents. GSR Ventures led the round with additional funding from other existing investors, including Sequoia Capital, Storm Ventures, Nextgen Venture Partners and Bixink Therapeutics. As Australia and New Zealand prepare to ease COVID-19 restrictions, New Zealand restricts POC testsPERTH, Australia As New Zealand and Australia prepare to open their economies, regulators in these two neighboring countries are taking very different approaches to regulating COVID-19 devices with New Zealand restricting point-of-care tests, while Australia imposes tougher postmarket activities. Shortage of needles, syringes looms in race to develop COVID-19 vaccineIn the rush to develop a COVID-19 vaccine, integral parts of the equation are being overlooked in the U.S., according to a whistleblower complaint filed this week by Rick Bright over his removal as director of the Biomedical Advanced Research and Development Authority (BARDA). Even if millions of doses of vaccine are ready to go by January, as the NIH’s Anthony Fauci a few weeks ago said could happen, there may not be enough needles and syringes to deliver those doses. Med-tech gainers and losers for May 4-8, 2020The top 10 med-tech stock gainers and losers for the week. BioWorld MedTech’s Neurology Extra for May 8, 2020Keeping you up to date on recent developments in neurology, including: Focused ultrasound opens brain for gene therapy; Study links early sleep problems to autism diagnosis; New trial platform could accelerate finding a cure for Parkinson\'s disease. Roche, Samsung partner to develop digital therapeutic for autism spectrum disorderDeals and M ADigital therapeutics have had a tough time gaining traction in the last few years. They’ve been hampered by sometimes reluctant payers, providers and regulators who lack familiarity with the approach, which typically employs an app or other technology to treat a patient by supporting behavioral... Fitbit targets AF with large-scale, virtual studyClinicalWearables giant Fitbit Inc. has kicked off its first large-scale, virtual study to evaluate how well its wrist-worn technology can spot episodes of irregular heart rhythm that might indicate atrial fibrillation (AF). The study, part of a broader plan to equip Fitbit devices with new tools to speed... COVID-19 pandemic in Chile encourages a surge of telemedicine productsTelehealthBOGOTA, Colombia – As it works to more efficiently fight COVID-19, Chile is developing new regulations to support and boost telemedicine with an eye on the current outbreak but also on improving the provision of health care in the country in the long term. Patients with chronic conditions, who are... Israel proving to be med-tech hub during COVID-19 pandemicDiagnosticsHONG KONG – Israeli companies have produced some promising med-tech solutions for COVID-19, and the artificial intelligence space is turning out to be a particularly strong area of expertise for that tiny but mighty nation. One of the four health maintenance organizations (HMO) in Israel, Maccabi... Grail’s cancer liquid biopsy test gets $390M boost from series D roundCancerLiquid biopsy startup Grail Inc., of Menlo Park, Calif., has reeled in $390 million in a series D financing that included new investors Public Sector Pension Investment Board and Canada Pension Plan Investment Board. Prior investor Illumina Inc., of San Diego, also participated in the round, as well as two unidentified backers. Israel’s Bat-Call makes a good call with auscultation for COVID-19 approachDiagnosticsHONG KONG – Whether bats are the source of COVID-19 is a debatable point; however, using sound to navigate like them could prove key for diagnostics and disease monitoring. Bat-Call Ltd. is using its auscultation technology in the battle against the pandemic. It said its patented artificial... Ventilator mounting system in front line war against COVID-19CanadaTORONTO – That old military saw \"an army marches on its stomach” might just as easily apply to transport of much needed ventilators for patients suffering from the coronavirus. Mounting systems for ground and air ambulances like the Bracket Pro Serie for Ventilators launched March 5 by Quebec... Astrotech enters COVID-19 fight with screening instrument for lung diseasesDiagnosticsAstrotech Corp., of Austin, Texas, has a broad range, having developed mass spectrometers in agriculture and manufacturing and selling chemical analyzers for use in the airport security and other applications. Now, it is looking to help in the fight against COVID-19. Abiomed up on solid earnings as it buys ECMO startup for heart pump combo, COVID-19 useCardiovascularThe restrictions on elective surgeries as hospitals struggle to manage the unfolding global pandemic are hitting medical device companies particularly hard. Abiomed Inc., which specializes in a tiny, minimally invasive heart pump to support heart failure patients, saw its first fiscal fourth-quarter revenue flatten as procedures were postponed. Still, U.S. revenue remained stronger than Wall Street had expected, even as ex-U.S. revenue had deeper declines. Cooperative research effort taking aim at genetics affecting COVID-19 infectionResearchLONDON – Leading genome sequencing groups are launching the first meta-analysis in the hunt for genetic factors that explain why some people have worse COVID-19 symptoms than others, after agreeing to share patient sequence data from around the world. The COVID-19 Host Genetics Initiative (CHGI), set up by scientists at the Institute for Molecular Medicine Finland (FIMM), now includes 151 registered studies that are searching for genetic variation associated with severity and outcomes. Biofourmis buys Gaido Health to gain complete oncology solutionOncologyBiofourmis Inc. has acquired Los Angeles-based Gaido Health from Takeda Pharmaceuticals in a move designed to significantly expand the company s oncology offerings. Gaido Health s solution will be integrated into Boston-based Biofourmis Biovitals platform, enhancing its ability to remotely monitor oncology patients at home using a single sensor. One Drop acquires assets of Sano IntelligenceDiabetesInformed Data Systems Inc., doing business as One Drop, purchased the assets and intellectual property of Sano Intelligence Inc. for an undisclosed amount. San Francisco-based Sano has been developing a wearable continuous glucose sensor that enables users to track blood glucose levels and other blood chemistry via a smart phone app for nearly a decade. One Drop will integrate the stick-on device into its personalized digital care program for diabetics and people with other chronic conditions. Newly renamed Cytiva retains heart of GE Healthcare’s biopharma manufacturing unitDrugsLONDON – These are hardly times for a fanfare, but this month saw the unveiling of a new name in bioprocessing, following the formal closing of the $21.4 billion sale of GE Healthcare’s Life Sciences to Danaher Corp. The business, now renamed Cytiva, has turnover of $3.3 billion, nearly 7,000 employees and operations in 40 countries. More than 75% of FDA-approved biologic drugs use its products in their manufacture. Roche discusses launch of newly approved serology test to detect COVID-19DiagnosticsPARIS In the wake of the news that Swiss group Roche Holding AG received an emergency use authorization from the U.S. FDA as well as a CE-IVD certification for the Elecsys Anti-SARS-CoV-2 serology test to detect antibodies in people previously exposed to SARS-CoV-2 that causes the COVID-19 disease, the company unveiled its plans for the launch of the product. Chinese researchers develop fast, sensitive COVID-19 antibody testCardiovascularResearchers in Guangzhou, China, have developed a nanoparticle-based lateral flow immunoassay that quickly and accurately detects antibodies to the SARS-CoV-2 virus that causes COVID-19. The current test, which works in a similar manner to a pregnancy test, detects IgG antibodies in blood in less... Australia bolsters diagnostics capability, surveillance in preparation for relaxing social distancing restrictionsDiagnosticsPERTH, Australia Australia is taking several measures to increase diagnostic testing for COVID-19 and rolling out a national surveillance app as it prepares to relax social distancing measures and get back to work. Youth involvement, tech startups and AI at the heart of Pakistan’s coronavirus fightDiagnosticsKARACHI, Pakistan – With limited resources, a growing outbreak and a tech savvy population, Pakistan is reaching into a diverse bag of tricks to find ways to battle COVID-19. Part of these efforts include at least one artificial intelligence (AI)-based diagnostic product as well as molecular... Pass the MUST-ARDS: Athersys starts pivotal study for stem cells to treat COVID-19-induced ARDSStem cellsStem cells haven t exactly panned out as hoped when it comes to approved therapeutics. There are only a couple that have received a nod from the FDA in very specific indications. But the ongoing COVID-19 pandemic could push stem cells back into the limelight and more firmly establish them as therapeutically relevant. D’oxyva targets COVID-19 patients with underlying conditionsCoronavirusPasadena, Calif.-based Circularity Healthcare LLC has initiated a clinical trial to evaluate its transdermal microcirculation device in COVID-19 patients with underlying health conditions. The aim is to see if use of the noninvasive deoxyhemoglobin vasodilator (from which the product derives its name) improves outcomes in patients suffering from coronavirus-related complications. Perspectum launches study of post-COVID-19 organ damageImagingOxford, U.K.-based Perspectum Diagnostics Ltd. is recruiting patients for a study to determine the degree of damage sustained by major organs following infection with the SARS-CoV-2 virus. The company will use its multiparametric magnetic resonance imaging (MRI) devices and other means to evaluate post-COVID-19 organ damage, track healing and evaluate impact on survivors. Study to evaluate benefit of Cardiologs’ AI-based tool in monitoring COVID-19 patientsArtificial intelligenceParis-based health care startup Cardiologs Technologies SAS has launched a clinical study to assess the use of its artificial intelligence (AI) platform to remotely monitor cardiac safety in COVID-19 patients being treated with the malaria drug hydroxychloroquine. The study could help to detect and prevent serious cardiac effects of the drug. Stony Brook, Chembio Diagnostics partner on COVID-19 trialPlasmaStony Brook Medicine has launched an FDA-approved, randomized investigational new drug (IND) trial to determine whether plasma from people who have recovered from COVID-19 can aid in the recovery of patients currently fighting the disease. Chembio Diagnostics Inc.\'s COVID-19 rapid serological point-of-care test will be used to identify potential plasma donors. Researchers develop long-lasting, flexible neural interfaceNeurology/PsychiatricThe human body constantly assaults medical devices that are implanted within it. The traditional solution to that has been to encase them in titanium. But that s not the best option in the brain, where it remains difficult to place a high number of electrodes without damaging the brain, while protecting the device from long-term damage. Next up for TAVR; bicuspid valveBioWorld MedTechNow that the existing inventory of FDA-approved transcatheter aortic valve replacement (TAVR) devices has received a green light for patients at low...