FDA authorizes first AI-powered armband for COVID-19 screening

FDA granted an emergency use authorization (EUA) for the first machine learning–based COVID-19 nondiagnostic screening device. The Tiger Tech COVID Plus Monitor identifies certain biomarkers that may be indicative of SARS-CoV-2 infection. It can also detect hypercoagulable conditions, such as sepsis or cancer, or hyper-inflammatory states in asymptomatic individuals over the age of 5 years.

FDA said the device, which is an armband embedded with light sensors and a small computer processor, is intended for use by trained personnel to help prevent exposure to and the spread of COVID-19.

“Combining use of this new screening device that can indicate the presence of certain biomarkers with temperature checks 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 health care facilities, schools, workplaces, theme parks, stadiums, and airports,” said Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, in a statement.

FDA said the device is not a substitute for a COVID-19 diagnostic test and is not intended for use in individuals with symptoms of COVID-19.