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

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

The Tiger Tech COVID Plus Monitor is supposed to be used by trained personnel to assist prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19. The device identifies certain biomarkers which can be indicative of SARS-CoV-2 disease additionally 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 meant to be used after a temperature reading that doesn’t meet standards for fever in configurations where temperature check has been conducted consistent with Centers for Disease Control and Prevention (CDC) and native institutional infection prevention and control instructions. This device isn't a replacement for a COVID-19 diagnostic evaluation and isn't meant to be used 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 the utilization of this new screening device, which will indicate the presence of certain biomarkers, with temperature checks could help identify individuals who could also be infected with the virus, thus helping to scale back the spread of COVID-19 during a big variety of public settings, including healthcare facilities, schools, workplaces, theme parks, stadiums, and airports.” 

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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 little 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 5 minutes. When the measurement is finished, the processor extracts some key characteristics of the signs of the input, like pulse, and feeds them into a probabilistic machine learning model that’s been trained to form predictions on whether the person is showing certain signals, like hypercoagulation in blood. Hypercoagulation is considered a standard abnormality in COVID-19 patients. The result's given within the sort of different colored lights wont to indicate if someone is demonstrating certain biomarkers, or if the result's inconclusive.

The clinical performance of the Tiger Tech COVID Plus Monitor was studied in hospital and faculty 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 have 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 varsity study, which was considered a confirmatory study, showed similar functionality.

The Tiger Tech COVID Plus Monitor isn't a diagnostic device and must not be wont to diagnose or exclude SARS-CoV-2 infection. The device is meant to be used on individuals without a fever. A person’s underlying condition may interfere with the COVID-19 related performance of the device and will cause an incorrect screening result.

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