FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate Coronavirus Infection
The U.S. Food and Drug Administration issued an emergency use authorization for the first machine learning-based, non-diagnostic screening device on March 19, 2021, that identifies certain biomarkers 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. 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 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 the criteria for fever.
The device is an armband with embedded light sensors and a small computer processor. The armband is wrapped around a person’s bare left arm above the elbow during use. The sensors first obtain pulsatile signals from blood flow over a period of three to five minutes.
Once the measurement is completed, the processor extracts some key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation in blood. Hypercoagulation is known to be a common abnormality in COVID-19 patients.
The result is provided in different colored lights used to indicate if an individual is demonstrating certain biomarkers or if the result is inconclusive.
Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, stated in a press release: “Combining the 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 coronavirus, thus helping to reduce the spread of (SARS-CoV-2) in a wide variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums, and airports.”
The Tiger Tech COVID Plus Monitor's clinical performance was studied in hospital and school settings, says the FDA.