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FDA Authorizes First AI-powered Armband for COVID-19 Screening

The USFDA has approved the first machine learning-based COVID-19 non-diagnostic screening device that identifies certain biomarkers that are indicative of some types of conditions, such as hypercoagulation. The device called Tiger Tech COVID Plus Monitor is intended to help prevent exposure to and spread of SARS-CoV-2.

It 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 for 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 that has been 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 the form of different colored lights used to indicate if an individual is demonstrating certain biomarkers, or if the result is inconclusive. The device was studied in hospital and school settings. In the study, 467 asymptomatic and 69 confirmed positive cases demonstrated that the Tiger Tech COVID Plus Monitor had a positive percent agreement (proportion of the COVID-19 positive individuals identified correctly by the device to possess certain biomarkers) of 98.6% 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%.

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