Researchers at Oxford University say early-stage results from a Phase I/II clinical trial of a SARS-CoV-2 vaccine candidate display safety and strong immune responses. Results, published in The Lancet, revealed that the vaccine is safe, causes few side effects and induces strong immune responses in both parts of the immune system in the fight against COVID-19, […]
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.
Quest COVID-19 test wins FDA nod for pooled sampling
The FDA has authorized a Quest Diagnostics (NYSE:DGX) test for COVID-19 to be used with pooled samples — the first such authorization by the agency since Dr. Anthony Fauci, the nation’s leading infectious disease specialist, started publicly discussing pooled-sample testing about three weeks ago. The authorization, announced Saturday, permits the pooled testing of up to four […]
FDA issues EUA for Luminex COVID-19 antibody test
Luminex (NSDQ:LMNX) announced today that it received FDA emergency use authorization (EUA) for its xMAP SARS-CoV-2 multi-antigen IgG assay for COVID-19. Austin, Texas-based Luminex said in a news release that its serology assay can identify the presence of antibodies in those who have been infected with the SARS-CoV-2 virus causing COVID-19. The newly authorized assay can […]
MedTech 100 roundup: Industry hits pandemic peak
After five months since medtech stocks peaked before the COVID-19 pandemic rocked the markets, the industry inched back toward that pre-pandemic high. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — sat at 88.9 points at the end of last week (July 17). That total represents just a -3.7% […]
COVID-19 diagnostics sales boost Abbott’s Q2 results
Abbott (NYSE:ABT) beat the consensus forecast on Wall Street today — with sales of molecular diagnostics including COVID-19 tests more than tripling. The Abbott Park, Ill.-based healthcare giant reported profits of $537 million or 57¢ per share, on sales of $7.33 billion for the three months ended June 30, 2020, for a bottom-line plunge of –47% […]
Feds to buy hundreds of thousands of COVID-19 antigen tests from BD
The U.S. Departement of Health and Human Services is turning to the new COVID-19 antigen test from Becton Dickinson (NYSE:BDX) as it seeks to boost rapid point-of-care testing. HHS will buy 2,000 BD Veritor Plus systems and 750,000 SARS-CoV-2 antigen test kits for use in a broad, decentralized network, BD said today. The distribution of the […]
XPrize sets $1m mask challenge
The XPrize global invention competition has announced a contest to develop a reimagined surgical face mask to protect against COVID-19. The 8-month contest is open to innovators age15 to 24 to come up with a face mask that will overcome common barriers to use. The three winning teams will split a $1 million prize purse and will […]
GM receives N95 certification for Michigan-made respirators
General Motors (NYSE:GM) announced today that the National Institute for Occupational Safety and Health has provided an N95-level certification for the respirators the automaker is churning out of its Warren, Mich. plant. NIOSH, which is part of the CDC, created the new certification process in order to increase the supply of filtering facepiece respirators needed […]
3M, MIT working on paper-based, rapid COVID-19 test
3M (NYSE:MMM) announced today that it is working with Massachusetts Institute of Technology (MIT) researchers to develop a paper-based, rapid test to detect the virus that causes COVID-19, with the potential to manufacture millions of tests per day. The test would detect viral antigens and deliver “highly accurate results within minutes” via a paper-based device, according […]
Federal Trade Commission sues online retailer over its PPE shipment speed claims
The Federal Trade Commission has sued online retailer SuperGoodDeals.com — claiming that it falsely promised consumers next-day shipping of facemasks and other personal protective equipment amid the COVID-19 pandemic. SuperGoodDeals’ website starting in March said PPE was “in stock,” and touted “Pay Today, Ships Tomorrow” — but it often took weeks for PPE merchandise to […]
ElectroCore lands EUA for COVID-19 vagus nerve stim use
ElectroCore this week said it received FDA emergency use authorization for its gammaCore Sapphire CV to treat asthma exacerbations in known or suspected COVID-19 patients. The gammaCore Sapphire CV is a non-invasive vagus nerve stimulation that can be used at home or in a healthcare setting to acutely treat adults with known or suspected COVID-19 […]