U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation (a condition causing blood to clot more easily than normal).
The Tiger Tech COVID Plus Monitor is intended for use by trained personnel to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19. The device identifies certain biomarkers that may be indicative of SARS-CoV-2 infection as well as other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory states (such as severe allergic reactions), in asymptomatic individuals over the age of 5. The Tiger Tech COVID Plus Monitor is designed for use following a temperature reading that does not meet criteria for fever in settings where temperature check is being conducted in accordance with Centers for Disease Control and Prevention (CDC) and local institutional infection prevention and control guidelines. This device is not a substitute for a COVID-19 diagnostic test and is not intended for use in individuals with symptoms of COVID-19.
“The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “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 healthcare facilities, schools, workplaces, theme parks, stadiums and airports.”
