The FDA announced that it authorized the first machine learning-based screening device for identifying COVID-19 biomarkers.
Tiger Tech Solutions’ COVID Plus Monitor received emergency use authorization (EUA) as a non-diagnostic screening device to identify certain biomarkers that indicate some types of conditions, including hypercoagulation (which causes blood to clot more easily than normal), according to an FDA release.
The monitor is intended for use by trained personnel to help prevent exposure to and the spread of SARS-CoV-2, the virus causing COVID-19. The biomarkers it identifies, including other hypercoagulable conditions (like sepsis or cancer) or hyper-inflammatory states, may indicate infection with the virus in asymptomatic individuals over the age of five.
Tiger Tech’s monitor is designed for use following a temperature reading that does not meet criteria for fever in settings where temperature check is being conducted under CDC and/or local guidelines. The device is not a substitute for a COVID-19 diagnostic, nor is it intended for use in symptomatic individuals.
Comprised of an armband with embedded light sensors and a small computer processor, the device is wrapped around a person’s bare left arm above the elbow. The sensors obtain pulsatile signals from blood flow over a period of three to five minutes before extracting key features of the pulsatile signals, like pulse rate, and feeding them into a probabilistic machine learning model trained to make predictions for certain signals. Results come through in the form of different colored lights to indicate if an individual is demonstrating certain biomarkers or if the result is inconclusive.
A hospital study enrolled 467 asymptomatic individuals, including 69 confirmed positive cases, and showed that the Tiger Tech COVID Plus Monitor correctly identified biomarkers in 98.6% of the COVID-19-positive population. It correctly identified 94.5% of COVID-19-negative individuals. A confirmatory school study showed similar performance levels.
“The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools,” FDA director of the Center for Devices & Radiological Health Dr. Jeff Shuren said in the release. “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.”