emergency use authorization approved

FDA Authorizes First COVID-19 Biomarker Screening Device

March 23, 2021

The FDA has granted Emergency Use Authorization for Tiger Tech Solutions’ Tiger Tech COVID Plus Monitor, a wearable device that identifies certain biomarkers which may indicate COVID-19 infection in asymptomatic patients.

The device, an armband with embedded light sensors, measures pulsations from blood flow and analyzes them using machine learning to identify certain features, such as hypercoagulation, that are common abnormalities in COVID-19 patients. It displays results using colored lights to indicate if a patient shows certain biomarkers or if the results are inconclusive.

The monitor is not intended to substitute for a COVID-19 diagnostic and shouldn’t be used in patients who show symptoms, the FDA said.

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