A new study by Laboratory Corp. of America Holdings (Labcorp) has found that nearly 9 in 10 COVID-19 patients continue to have antibodies to SARS-CoV-2 proteins 10 months after infection. Published in The Lancet-affiliated Eclinicalmedicine, the study provides real-world evidence of the persistence of SARS-CoV-2 antibodies in infected individuals, though the authors said more research is needed to determine if, and to what degree, protection against reinfection persists. Read More
The European Commission's (EC) Medical Device Coordination Group (MDCG) has provided a set of templates to fulfill European Medical Device Regulation (MDR) requirements on submitting clinical investigation application and notification documents in the absence of the European database on medical devices (EUDAMED). Read More
The May 25 appearance of Francis Collins, director of the U.S. National Institutes of Health, before a congressional committee revolved in large part around the Biden administration’s so-called ARPA-H proposal, but the administration’s proposal to waive intellectual property rights for vaccines was also on tap. Read More
With $41 billion in sales, the medical technology market in Germany leads Europe, followed by France and Italy, which each manage only half the sales of Germany each month. The U.K., in fourth place, barely sees one-fifth of Germany's revenues, according to a report from BVMed, the German association of medical device manufacturers. German firms also reported a 4.9% reduction in business in 2020 due principally to the COVID-19 pandemic. Read More
With a number of Medicare coverage policies in flux, the U.S. Senate has confirmed Chiquita Brooks-LaSure as the next CMS administrator, closing out one more critical remaining position for the Biden administration at the Department of Health and Human Services. Still unannounced is the administration’s nominee to lead the FDA, an omission that becomes more conspicuous with each passing day. Read More
HONG KONG – Genetron Holdings Ltd. is teaming up with JD Health International Inc. to develop full-cycle cancer management solutions encompassing both online and offline components. The partnership will focus on the six key areas of consumer health care, digitization of liver disease management, government medical associations, sharing of customer screening resources, industry, and user education as well as the consolidation of oncology doctors and experts on a single platform. Read More
With the support of the NIH’s National Institute of Child Health and Human Development and the National Institute of Mental Health, researchers at Duke University’s Center for Autism and Brain Development have developed a mobile app that can quickly screen toddlers for autism spectrum disorder without the need for specialized skills. Read More
New hires and promotions in the med-tech industry, including: Modular Medical, Nextgen Healthcare, Noom, Outset Medical, Pelvital, Progenity, Proxamo, Tela Bio. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Foldax, Geneoscopy, Noctrix Health, One Medical, Procyrion. Read More
Med-tech happenings, including deals and partnerships, grants, preclinical data and other news in brief: Adventhealth, Alpha Imaging, Anpac Bio-Medical Science, Burstiq, Confluent Medical Technologies, Drawbridge Health, F-Star Therapeutics, GT Medical Technologies, Henry Schein, Inivata, Isoplexis, Jarvis Analytics, Ka Imaging, Lifebit Biotech, Mount Sinai Genomics, Nexstim, Novocure, Paige, Promis Neurosciences, Quest Diagnostics, Rulestar, Thorne Healthtech, Waters. Read More
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Advanced Biological Laboratories, Amg International, Choicespine, Guard Medical, Ihealthscreen, Jenavalve, Quidel, Unity HA, Uroviu. Read More
