FDA approves first AI based COVID-19 non-diagnostic screening

Overview

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• Source: U.S. Food and Drug Administration


• Date: 21 Mar,2021

Now, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first machine learning-based Coronavirus Disease 2019 (COVID-19) non-diagnostic testing apparatus that identifies certain biomarkers that are indicative of some kinds of conditions, such as hypercoagulation (a condition causing blood to clot more readily than normal).

The Tiger Tech COVID Plus Monitor is meant 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 which may be indicative of SARS-CoV-2 disease in addition to other hypercoagulable conditions (such as sepsis or cancer) or hyper-inflammatory conditions (such as severe allergic reactions), in asymptomatic individuals over age 5. The Tiger Tech COVID Plus Monitor is designed for use after a temperature reading that doesn’t meet standards for fever in configurations where temperature check has been conducted according to Centers for Disease Control and Prevention (CDC) and local institutional infection prevention and control instructions. This device is not a replacement for a COVID-19 diagnostic evaluation and is not meant for use in people 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. 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.”  

Jeff Shuren, M.D., J.D., Director, FDA’s Center for Devices and Radiological Health

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 usage. The detectors first obtain pulsatile signals from blood flow over a period of three to five minutes. When the measurement is finished, the processor extracts some key characteristics of the inputs signs, such as pulse rate, and feeds them into a probabilistic machine learning model that’s been trained to make predictions on whether the person is showing certain signals, such as hypercoagulation in blood. Hypercoagulation is regarded as a common abnormality in COVID-19 patients. The result is given in the form of different colored lights used to indicate if someone is demonstrating certain biomarkers, or if the result is inconclusive.

The clinical performance of the Tiger Tech COVID Plus Monitor was studied in hospital and school settings. The hospital research, which was considered a validation study, enrolled 467 asymptomatic people, including 69 confirmed positive cases, also demonstrated that the Tiger Tech COVID Plus Monitor had a positive percent agreement (proportion of the COVID-19 positive individuals identified properly by the device to own certain biomarkers) of 98.6% and a negative percentage agreement (proportion of their COVID-19 negative individuals identified correctly by the device to not have certain biomarkers) of 94.5%. The school study, which was considered a confirmatory study, showed similar functionality.

The Tiger Tech COVID Plus Monitor is not a diagnostic device and must not be used to diagnose or exclude SARS-CoV-2 infection. The device is intended for use on individuals without a fever. A person’s underlying condition may interfere with the COVID-19 related performance of the device and could lead to an incorrect screening result.