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 Administration for Strategic Preparedness and Response June 25 announced a flu pandemic preparedness and response strategy in response to the threat of…
Headline
The Food and Drug Administration last week granted enforcement discretion for the use of conjunctival swabs by laboratories as part of human testing for H5N1…
Headline
The Food and Drug Administration May 23 announced that Medline Industries, a firm marketing and distributing Chinese-manufactured plastic syringes within the U…
Blog
The RAND Corporation recently released the fifth iteration of its biannual hospital price report. The AHA has previously highlighted significant flaws with…
Headline
The Centers for Disease Control and Prevention May 21 announced recommendations that flu surveillance systems continue operating at enhanced levels during the…
Headline
The Food and Drug Administration yesterday announced an import alert for plastic syringes manufactured by two China-based manufacturers, in addition to…