FDA authorizes screening device for SARS-CoV-2 biomarkers

The Food and Drug Administration (FDA) issued an emergency use authorization for the Tiger Tech COVID Plus Monitor, the first machine learning-based COVID-19 non-diagnostic screening device. The monitor identifies biomarkers associated with conditions such as hypercoagulation, which can be indicative of SARS-CoV-2 or other hypercoagulable conditions like sepsis or cancer. Providers can use the device to prevent exposure to and the spread of COVID-19 in settings where temperature checks indicate no fever, but the monitor should not be used as a substitute for COVID-19 diagnostic testing or for individuals with COVID-19 symptoms. (FDA news release, 3/19/21)