FDA authorizes device to screen asymptomatic people for certain SARS-CoV-2 biomarkers

The Food and Drug Administration Friday authorized for emergency use an armband device that screens people without COVID-19 symptoms for certain potential SARS-CoV-2 biomarkers, such as excessive blood clotting. 

The agency authorized the Tiger Tech COVID Plus Monitor for use in settings conducting temperature checks in accordance with infection control guidelines.

When combined with temperature checks, the new screening device “could help identify individuals who may be infected with the virus, thus helping to reduce the spread of COVID-19 in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums and airports,” said Jeff Shuren, M.D., director of FDA’s Center for Devices and Radiological Health.