One of the challenges in controlling the rate of new infections during the COVID-19 pandemic has been the lack of a diagnostic test specifically indicated for asymptomatic patients. According to some estimates, nearly 40% of the new cases of SARS-CoV-2 infections do not have any visible symptoms. As a result, many of those infected are not aware they are carrying the virus and may be inadvertently adding to the rising rates of new infections. A newly authorized diagnostic test for asymptomatic patients could help.
Read MoreFDA is expanding the Abbreviated 510(k) Program with a Safety and Performance-based Pathway for certain medical devices.
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