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FDA Issues EUA for First Machine Learning Device That Screens for COVID-19

FDA maze of regulations

Machine learning device gains FDA EUA as a COVID-19 screening method

The US Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) that is the first of its kind. The EUA was issued for the Tiger Tech COVID Plus Monitor, a machine learning-based COVID-19 screening device that identifies biomarkers that can indicate an individual has a SARS-CoV-2 infection.

This device is a noninvasive armband that is designed to be used as an advanced screening tool to identify individuals who may have COVID-19 without requiring an antigen or molecular test.

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

While the Tiger Tech COVID Plus Monitor is innovative and has many potential applications, the FDA emphasizes that this device does not replace laboratory testing for COVID-19 and cannot be used to definitively rule out or diagnose a COVID-19 infection.

Related Resource:

FDA: FDA Authorizes First Machine Learning-Based Screening Device to Identify Certain Biomarkers That May Indicate COVID-19 Infection