A wearable COVID screening device that uses light sensors to check for signs of infection has gotten FDA regulatory clearance. The Tiger Tech COVID Plus Monitor is worn on the arm and detects hypercoagulation—an upsurge in the clotting of blood, and also a telltale sign of SARS-CoV-2 infection.
Tiger Tech’s armband screening tool is roughly the size of a pack of cards and measures the pulse and blood flow for around three minutes and then displays color-coded lights to indicate the final result: Green and you’re good to go, red and you should follow up with a healthcare professional.
The monitor, the first machine learning-based COVID-19 screening device, is not designed to completely replace conventional assay-based COVID tests, but instead, for use as a follow-up when an individual shows signs of an elevated temperature. The technology was developed as a result of a collaboration between physicians and engineers at the Mount Sinai Medical Center in Miami Beach, Florida.
Tiger Tech’s device was put to the test in a hospital study which included a cohort of 467 individuals showing no signs or symptoms of COVID-19. Of these, 69 were confirmed positive cases. The monitor correctly picked up 98.6 percent of the COVID-19-positive patients and accurately identified 94.5 percent of the negative cases.
A hospital study enrolled 467 asymptomatic individuals, including 69 confirmed positive cases, and showed that the Tiger Tech COVID Plus Monitor correctly identified biomarkers in 98.6% of the COVID-19-positive population. It correctly identified 94.5% of COVID-19-negative individuals. A confirmatory school study showed similar performance levels.
FDA’s director of the Center for Devices & Radiological Health, Dr. Jeff Shuren, said that the organization is committed to bringing innovative new screening technologies as countermeasures against the pandemic.
“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,” said Shuren.
With around 7 million COVID cases in the U.S., this new combinatorial screening approach could help regain control of the pandemic as vaccination efforts continue.