FDA approves combo test for flu, COVID-19; alerts providers to medical device risksÂ
The Food and Drug Administration recently granted 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 for potential device failure, and patients with certain implantable for potential serious complications.
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