CorVent Medical announced today that it received FDA emergency use authorization (EUA) for primary critical care use of its Respond-19 ventilator. Respond-19 is designed for the rapid expansion of critical care ventilation capacity by allowing hospitals to treat more patients suffering from acute respiratory distress syndrome (ARDS) amid the COVID-19 pandemic, according to a news […]
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.
BREAKING: FDA says Pfizer’s COVID-19 vaccine meets success criteria
The FDA today said that the COVID-19 vaccine candidate made by Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) meets success criteria. Ahead of an advisory meeting on Thursday, Dec. 10, to review the vaccine candidate, the FDA found that data from Pfizer and BioNTech’s trials was “consistent” with its recommendations for emergency use authorization and that the candidate […]
FDA authorizes at-home COVID+flu test from Quest Diagnostics
The FDA has given emergency use authorization for a COVID-19 and flu combination diagnostic from Quest Diagnostics (NYSE:DGX). In a letter to San Juan Capistrano, Calif.-based Quest Diagnostics, the FDA said that, while it has approved tests for influenza A and influenza B, there are no FDA-approved multiplexed tests for flu/SARS-CoV-2 combination testing. Additionally, no self-collected, […]
Biden makes picks for HHS secretary, CDC director
President-elect Joe Biden has made selections for leaders of the U.S. Dept. of Health & Human Services and the Centers for Disease Control & Prevention. Biden chose California Attorney General Xavier Becerra as his nominee for HHS secretary. The 12-term veteran of U.S. Congress had previously advocated for healthcare issues as AG in California and […]
MedTech 100: New heights reached once again
Nearly a month after reaching a new high mark, the medtech industry once again shot up to reach another peak in its mid-pandemic rebound. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished last week at 100.75 (Dec. 4), marking a 2.6% uptick from the 98.23 points registered […]
CDC urges universal mask use when not at home
With the pandemic death toll reaching new heights every day, the U.S. Centers for Disease Control and Prevention issued a blanket recommendation for the nation on Friday: Every American should wear a face mask when not at home. And when they are at home with someone who is infected or has had recent potential COVID-19 […]
3B Medical wins EUA for mask decontamination in nursing homes
3B Medical announced that it received FDA emergency use authorization (EUA) for the use of its Lumin UVC system for N95 mask decontamination. Lumin is designed for cleaning CPAP accessories but is also used as a multi-purpose sanitizer, 3B Medical said in a news release. The FDA EUA allows for the use of Lumin by healthcare […]
Which COVID-19 diagnostics are most sensitive?
The FDA SARS-CoV-2 Reference Panel released a comparison pitting COVID-19 diagnostics against each other for superior sensitivity. Developers of the diagnostics are asked to perform a range-finding limit of detection (LoD) for detectable units per mL, according to the FDA release. The PerkinElmer New Coronavirus Nucleic Acid Detection Kit and the Viracor SARS-CoV-2 assay led […]
FDA agrees on independent confirmation needs for COVID-19 antibody tests
The FDA issued a letter confirming that all emergency use-authorized COVID-19 antibody serology tests should be supplemented with a second, independent test. The letter, dated Dec. 1, 2020, states that the FDA concurs with the additional statement to Abbott’s (NYSE:ABT) fact sheet for healthcare providers which outlines the risk of false-positve results. FDA received the supplement […]
3M to lay off another 2,900 in $300M restructuring
3M (NYSE:MMM) announced today that it will lay off an additional 2,900 workers in an ongoing restructuring that will cost the company up to $300 million. The Maplewood, Minn.-based manufacturing conglomerate said the cuts would span across its businesses and geographies, resulting in a total pre-tax charge of $250 million to $300 million — including $120 […]
Everlywell raises $175M
Everlywell announced today that it completed an oversubscribed Series D financing round, bringing in proceeds of $175 million. Austin, Texas-based Everlywell’s latest round included new investors such as BlackRock, The Chernin Group (TCG), Foresite Capital, Greenspring Associates, Lux Capital, Morningside Ventures, and Portfolia, as well as existing investors Goodwater Capital, Highland Capital Partners, and Next […]