Medtronic (NYSE:MDT) announced that it donated nearly $1 million worth of personal protective equipment (PPE) in response to COVID-19. Fridley, Minn.-based Medtronic donated the PPE to relief organization International Medical Corps in support of its ongoing COVID-19 response efforts in the U.S. and Puerto Rico, according to a news release. The donation includes more than 1.1 […]
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.
Labor unions, environmental groups sue feds over lack of PPE
Labor unions ranging across several types of frontline workers today joined environmental groups in a lawsuit against the federal government. Unions representing healthcare workers, teachers, transit operators and millions more joined the environmental groups to sue the feds over their failure to provide adequate reusable respirators, N95 masks, gloves and other personal protective equipment (PPE) […]
EU orders 200M J&J COVID-19 vaccine doses
Johnson & Johnson (NYSE:JNJ) announced today that its set to provide 200 million doses of its COVID-19 vaccine candidate to Europe. The European Commission, on behalf of the European Union, approved an advance purchase agreement in which J&J subsidiary Janssen Pharmaceutical, which is developing the vaccine candidate, would supply the doses to EU member states following […]
J&J exec denies pressure to rush COVID-19 vaccine
Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed […]
FDA amends Hologic EUA for asymptomatic COVID-19 test
Hologic (NSDQ:HOLX) announced that its Aptima SARS-CoV-2 assay now has authorization for testing individuals without symptoms. Aptima received FDA emergency use authorization (EUA) in May as a COVID-19 test, and this week the FDA amended the EUA to include testing for asymptomatic individuals or those with other reasons to suspect COVID-19 infection, according to a news […]
J&J exec denies pressure to rush COVID-19 vaccine
Johnson & Johnson’s (NYSE:JNJ) chief scientific officer said today that the first doses of his company’s COVID-19 vaccine could be available for frontline healthcare workers in January or February, but added the company isn’t rushing it. If granted an emergency use authorization by the FDA, that’s the earliest Dr. Paul Stoffels said the single-dose vaccine developed […]
NIH announces more than $98M in contracts for new COVID-19 testing tech
The National Institutes of Health today announced six new contracts worth $98.35 million for COVID-19 testing approaches to improve sample collection, processing and results. NIH awarded the contracts in collaboration with the Biomedical Advanced Research and Development Authority (BARDA) as part of the Rapid Acceleration of Diagnostics (RADx) initiative. They cover innovations including integration with […]
FDA warns Battelle on reporting mask decontamination problems
The FDA is warning Battelle Memorial Institute that it must improve its adverse event reporting procedure for decontaminating N95 masks for reuse by frontline healthcare workers treating COVID-19 patients. The agency granted an emergency use authorization (EUA) in March for the Battelle Critical Care Decontamination System (CCDS), which uses vaporized hydrogen peroxide to reprocess used N95 […]
Abbott defends rapid COVID-19 test with interim trial results
Abbott (NYSE:ABT) has launched another defense of its ID NOW rapid COVID-19 diagnostic test, this time with interim clinical trial results that confirm assertions the company made in May. A total of 1,003 people were evaluated in urgent care clinics, hospitals and nursing homes, where Abbott said ID NOW delivered the following results compared with those […]
FDA defies Trump on vaccine approval timeline
The FDA today told COVID-19 vaccine developers that it needs two months’ worth of safety data before it will consider emergency approvals. The agency’s move cast further doubt on a vaccine against SARS-COV-2 being ready by election day, November 3 — a notion mentioned repeatedly by President Trump in attempts to pressure the agency to […]
CDRH director Shuren says flexibility remains key as COVID-19 strains regulatory system
Dr. Jeffrey Shuren, the director of the FDA’s Center for Devices and Radiological Health (CDRH), believes the level of flexibility shown by the FDA during the COVID-19 pandemic may be needed in a post-pandemic world. Speaking in a town hall event at The Virtual Medtech Conference hosted by AdvaMed, Shuren outlined the work the FDA has put […]