Steris (NYSE:STE) has won an FDA emergency use authorization (EUA) for a new steam sterilization method to decontaminate used N95 respirators. The EUA covers the new Steris Steam Decon cycle to decontaminate 3M 1860, 3M 1860S, and 3M 1804 NIOSH-approved N95 respirators that are or might be contaminated with SARS-CoV-2 and other pathogenic microorganisms. The FDA […]
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.
FDA clears 4D Medical’s lung imaging technology
4DMedical announced that it received FDA clearance for its XV Technology for analyzing functional lung impairment from a single X-ray. Australia-based 4DMedical (formerly 4DX), which has a U.S. base in Woodland Hills, Calif., designed the XV Technology as a four-dimensional lung imaging process in the form of a software-as-a-service (Saas) diagnostic tool. The software rapidly […]
Merck, IAVI work to develop COVID-19 vaccine
Merck (NYSE:MRK) and IAVI announced today that they are collaborating to develop an investigational vaccine against SARS-CoV-2 for preventing COVID-19. The vaccine candidate is slated to use the recombinant vesicular stomatitis virus (rVSV) technology used as the basis for Merck’s Ervebo Ebola Zaire virus vaccine, which was the first such vaccine to be approved for use in humans, […]
FDA signals PPE shortage, issues EUA for more
The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country. The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical […]
Report: New Medtronic CEO challenges Trump on ‘reshoring’
New Medtronic (NYSE:MDT) CEO Geoff Martha openly disagreed yesterday with President Donald Trump’s mission to bring formerly U.S.-based companies back to this country, according to a report in the Irish Times. Medtronic, which maintains a U.S. headquarters in Fridley, Minn., bought Dublin-based Covidien for $50 billion in 2015 and moved its global headquarters to Ireland in […]
FDA eases regs on certain device changes during pandemic
The FDA will allow limited changes to certain devices so medtech companies can address manufacturing and supply chain issues due to COVID-19-related disruptions. In a guidance released yesterday, the agency said it would allow changes to devices approved through its premarket approval (PMA) and humanitarian device exemption (HDE) pathways as long as those changes do not create […]
Abbott: ID NOW COVID-19 results more accurate with earlier testing
Abbott (NYSE:ABT) said today that its ID NOW COVID-19 test works better on specimens collected soon after patients begin showing symptoms. The test’s performance has drawn fire from federal officials in recent weeks, including a recent FDA warning that the ID NOW test may return false-negative results. The agency granted the test an emergency use authorization […]
This wearable could help people practice safe distancing amid COVID-19
Imec spinoff Lopos, with the Ghent University (Belgium) announced the Lopos SafeDistance wearable for promoting safety during the COVID-19 pandemic. As businesses attempt to return to in-person activities, the collaboration designed the wearable device to warn employees through an audible or haptic alarm when they are violating social distancing guidelines as they approach each other. […]
Abbott to supply millions of its COVID-19 antibody tests to U.K. government
Abbott (NYSE:ABT) will supply millions of its laboratory-based COVID-19 antibody tests to the U.K.’s National Health Service over the coming months under a contract announced today. The company has already shipped 800,000 of the IgG antibody test to NHS laboratories this week. The news comes on the same day that Abbott said that Health Canada has […]
NFL looking at modified facemasks for helmets
NFL Players Association medical director Thom Mayer told ESPN that the league is developing facemasks to protect players from COVID-19. Speaking to ESPN reporter Adam Schefter on The Adam Schefter Podcast, Mayer said the league and Oakley are testing prototypes of helmets with a modified facemask that could contain surgical material or even the material […]
Health Canada authorizes Abbott COVID-19 antibody test
Abbott (NYSE:ABT) announced today that Health Canada has granted interim authorization for its Architect SARS-CoV-2 IgG serology test for COVID-19. The Abbott Park, Ill.-based company won an FDA emergency use authorization and the CE Mark for the same antibody test for use on its Architect system in April. The test is designed to detect the IgG […]