Medtech stocks rebounded from a significant dip earlier in June last week, continuing to highlight the topsy-turvy nature of the markets during the COVID-19 pandemic. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 85.00 points at the end of last week (June 19). That total represents […]
Here at MassDevice — medtech's online business journal — we're covering news about the coronavirus (COVID-19) pandemic daily. Here is the latest about coronavirus and the medical device industry, regulatory changes related to the pandemic, new tests for the virus, vaccine development, and much more.
FDA warns against using certain COVID-19 tests
The FDA issued a statement recommending that clinical laboratories and healthcare providers stop using COVID-19 antibody tests on its “removed” list. Found under the FDA’s FAQs on Testing for SARS-CoV-2 page, the removed list includes tests for which significant clinical performance problems were identified and cannot or have not been addressed by the manufacturer in […]
Assisted living survey shows ongoing struggle for supplies during COVID-19 pandemic
A survey of National Center for Assisted Living members revealed that a number of people are still facing equipment shortages during the COVID-19 pandemic. Assisted living facilities have been hit particularly hard by the virus, with a recent report from the Associated Press citing government data confirming that nursing home residents account for nearly 1 […]
Merck acquires Themis to speed COVID-19 vaccine development
Merck (NYSE:MRK) announced today that it completed the acquisition of vaccine and immune-modulation therapy developer Themis for an undisclosed amount. In connection with the acquisition, the U.S. Federal Trade Commission granted early termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, while Merck gained merger control from the Austrian Federal Competition Authority, […]
FDA expands public-private effort on COVID-19 research
The FDA announced that it is participating in the COVID-19 Diagnostics Evidence Accelerator project to advance the development of diagnostics. Organized by the Reagan-Udall Foundation for the FDA and in collaboration with Friends of Cancer Research, the multi-stakeholder project is the companion to the previously announced Therapeutic Evidence Accelerator for sharing insights, comparing results and […]
3M settles N95 price-gouging suit
3M (NYSE:MMM) has reached a settlement ending one of its lawsuits against companies selling marked-up N95 respirator masks amid the COVID-19 pandemic. In the filing, dated June 18, 3M moved to dismiss its case against TAC2 Global, a Clearwater, Fla.-based company that “specializes in an extensive selection of specialized tactical gear, ballistic protection and apparel,” according […]
GE Healthcare launches chest X-ray AI to better spot COVID-19
Officials at GE Healthcare (NYSE:GE) think the company’s new Thoracic Care Suite — a collection of eight AI algorithms from Lunit Insight CXR — could help clinicians in the fight against COVID-19. The AI suite, launched today, quickly analyzes chest X-ray findings and flags abnormalities for radiologist review, according to GE. It can spot potential pneumonia […]
HHS spending $347m to boost supply of COVID-19 vaccine, treatment vials
The U.S. Dept. of Health & Human Services (HHS) and Dept. of Defense (DoD) announced a joint effort to increase manufacturing for vials earmarked for COVID-19-related drugs and vaccines. The Biomedical Advanced Research and Development Authority (BARDA), as part of HHS, collaborated with DoD to provide funding for U.S.-based companies Corning Inc. and SiO2 Materials […]
FDA issues warning letters to companies selling antibody tests
The FDA announced that it issued warning letters to three companies for marketing adulterated and misbranded COVID-19 antibody tests. Medakit, Antibodiescheck.com and Yama Group and Dr. Jason Korkus, DDS & Sonrisa Family Dental d/b/a My COVID19 Club all received warnings. In the warnings, the agency outlined violations including offering test kits for sale in the […]
Beckman Coulter wins CE Mark for COVID-19 antibody test
Beckman Coulter announced this week that its Access SARS-CoV-2 IgG antibody assay received CE Mark approval and is commercially available in Europe. Brea, Calif.-based Beckman Coulter said in a news release that it already shipped tests to more than 400 hospitals, clinics and diagnostic laboratories in the U.S. and has begun to ship around the […]
FDA revokes EUA for COVID-19 antibody test
The FDA announced that it revoked the emergency use authorization (EUA) of the Chembio DPP COVID-19 antibody test due to accuracy concerns. Chembio’s IgM/IgG SARS-CoV-2 serological antibody test received EUA in March as a fingerstick-style test designed to use the company’s MicroReader 1 and MicroReader 2 analyzers to detect IgM and IgG antibodies and offer […]
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