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 […]
coronavirus
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.
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 […]
CAE receives Health Canada nod for CAE Air1 ventilator
CAE (NYSE:CAE) announced today that its CAE Air1 ventilator received certification from Health Canada and is set to treat people with COVID-19. Two months ago, the Canadian government issued a contract to CAE to manufacture and supply 10,000 ventilators amid the COVID-19 pandemic. The devices deliver pressure control, volume control and pressure support ventilation using […]
CEO Kevin Lobo says Stryker ready to regain lost momentum
Stryker (NYSE:SYK) CEO Kevin Lobo said today that the company is preparing to restart “a number” of idled production lines next month as it climbs out the crater created by COVID-19. In an interview on the DeviceTalks Weekly Podcast, Lobo said the company is rebounding from its low point in April, when its sales fell almost […]
Oxford researchers find widely available steroid reduces COVID-19 deaths
Oxford researchers announced today that, following testing with thousands of patients, dexamethasone may improve patient survival in cases of COVID-19. Dexamethasone is a corticosteroid commonly used for treating arthritis and other cases of inflammation. In total, 2,104 patients were randomized in Oxford’s trial to receive dexamethasone in doses of 6 mg, once per day, either […]
States reportedly fend for themselves with inflated ventilator prices
States had to scramble to obtain ventilators after the White House left them to fend for themselves, according to a Kaiser Health News report. Demand for intensive care unit ventilators skyrocketed as healthcare facilities dealt with the surges of COVID-19 patients over the course of the pandemic, which still goes on today after gaining steam […]