FDA approves combo test for flu, COVID-19; alerts providers to medical device risks
The Food and Drug Administration recently granted emergency use authorization for the first over-the-counter home antigen test to detect both flu and COVID-19. The OSOM Flu SARS-CoV-2 Combo Home Test is authorized for use to detect and differentiate influenza A and B and SARS-CoV-2 in nasal swab specimens from people aged 14 and older when conducted at least twice over three days with at least 48 hours between tests.
In other news, the FDA last week recommended health care providers monitor patients with the Hintermann Series H3 Total Ankle Replacement system for potential device failure, and patients with certain implantable BioZorb breast tissue markers for potential serious complications.
Related News Articles
Headline
The Department of Health and Human Services Dec. 10 amended the Public Readiness and Emergency Preparedness Act declaration for COVID-19, extending liability…
Headline
AHA's latest social media toolkit for encouraging vaccination against the flu and COVID-19 provides fall-themed social media posts and graphics. Download the…
Headline
AHA's latest social media toolkit for encouraging vaccination against the flu and COVID-19 celebrates the changing foliage, Thanksgiving and more. Download the…
Headline
The Centers for Disease Control and Prevention last week endorsed a recommendation for people aged 65 and older and for immunocompromised individuals to…
Headline
The Centers for Medicare & Medicaid Services Oct. 22 released final guidance detailing reporting requirements for the hospital respiratory data condition…
Headline
Four workers at a commercial egg farm in Washington tested presumptively positive for H5N1 bird flu, the Washington State Department of Health announced Oct.…