FDA approves emergency use of a non-diagnostic COVID-19 screening device

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for the first machine learning-based COVID-19 non-diagnostic screening device. The Tiger Tech COVID Plus Monitor identifies certain biomarkers that are indicative of COVID-19, among other conditions, such as hypercoagulation. 

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 five years old.

It 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). The FDA cautioned that 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.

“The FDA is committed to continuing to support innovative methods to fight the COVID-19 pandemic through new screening tools,” said Dr Jeff Shuren, 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.” 

The device is an armband with embedded light sensors and a small computer processor. It is wrapped around a person’s bare left arm above the elbow and used to detect pulsatile signals from blood flow over a period of three to five minutes. Once these measurements are completed, the processor extracts some key features of the pulsatile signals, such as pulse rate, and feeds them into a probabilistic machine learning model that has been trained to make predictions on whether the individual is showing certain signals, such as hypercoagulation. The result is provided in the form of different coloured lights used to indicate if an individual is demonstrating certain biomarkers or if the result is inconclusive.

The Tiger Tech COVID Plus Monitor’s clinical performance was studied in hospital and school settings. The hospital (validation) study enrolled 467 asymptomatic individuals, including 69 confirmed positive cases and demonstrated that the device had a positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6 percent and a negative percent agreement (proportion of the COVID-19 negative individuals identified correctly by the device to not possess certain biomarkers) of 94.5 percent. In the school (confirmatory) study it had a similar performance.

The FDA issued the EUA to Tiger Tech Solutions Inc.