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 Occupational Safety and Health Administration June 30 released a proposed rule to remove what remains of its emergency temporary standard for occupational…
Headline
The Food and Drug Administration issued Class I recalls, the most serious type, for two Smiths Medical infusion pumps due to the potential for serious injury…
Headline
Department of Health and Human Services Secretary Robert F. Kennedy Jr. May 27 announced in a post on X that the Centers for Disease Control and Prevention…
Headline
The Food and Drug Administration has identified a Class I recall of certain lots of BD esophagogastric balloon tamponade tubes due to the potential for serious…
Headline
Leaders of the Food and Drug Administration May 20 announced new guidelines for administering the COVID-19 vaccine in a paper published by the New England…
Headline
Though seasonal flu activity is low or minimal across the country, 216 pediatric deaths associated with seasonal influenza virus infection have been tallied so…