FDA Authorises First ML-Based COVID Screening Device

The US Food and Drug Administration (FDA) has issued an emergency use authorisation (EUA) for a Tiger Tech-released ML-based COVID-19 non-diagnostic screening device — COVID Plus Monitor. Termed to be first-of-its-kind, COVID Plus Monitor leverages machine learning that identifies certain biomarkers indicative of the virus that causes COVID-19.

The Tiger Tech COVID Plus Monitor has been designed for use by trained personnel to prevent exposure and spread of the deadly virus, SARS-CoV-2, as well as to identify biomarkers that are specifying other conditions like hypercoagulation, where the blood tends to clot more easily than normal, or hyper-inflammatory states, such as severe allergic reactions, in asymptomatic individuals over the age of five. 

The screening tool is an armband that is equipped with light sensors and a small computer processor, which when wrapped around the patient’s bare arm, will provide the prediction of whether the individual is showing COVID symptoms or not. It first obtains pulsatile signals from blood flow, which is then used to extract some key features such as pulse rate. These pulse rates are then fed into an ML model, which then makes the necessary predictions. The results are then displayed using coloured lights on the armband that indicates the presence of certain biomarkers.

According to the FDA’s official release, the device is not a substitute for the COVID-19 diagnostic test; however, it can be used by asymptomatic individuals without fever. The trained personnel checks this by carrying out a temperature reading. When it doesn’t meet the criteria, they can then use the COVID Plus Monitor device.

When asked about this new release, Jeff Shuren, MD, JD, director of FDA’s Center for Devices and Radiological Health, stated in the official release that FDA is committed to supporting innovative ways to fight this deadly pandemic. He said that using this new screening tool along with temperature checks will help healthcare workers identify patients infected with this virus, which in turn will reduce the spread and provide better treatment to them.
Tiger Tech COVID Plus Monitor has been evaluated in hospitals and schools where it showed a positive per cent agreement of 98.6%, by accurately identifying COVID positive individuals, and a negative per cent agreement of 94.5%, where it correctly identified the proportion of the COVID negative individuals that do not possess certain biomarkers. However, the release has also stated that a patient’s underlying condition can sometimes interfere with the COVID related performance of the device and lead to an incorrect screening result.