Wrist-based early alert for COVID cleared for sale in Europe
An MIT spinoff based in Boston and Milan in Italy has earned CE certification for software that flags respiratory infection in wearers of the company’s smartwatch devices.
Empatica announced the European go-ahead March 9, saying the new system, Aura, can detect COVID-19 in asymptomatic individuals.
The program is designed to run on Empatica’s Embrace Plus and E4 wristlets.
The company says that, in validation studies, Aura showed a sensitivity of 0.94 for identifying patients likely to be infected with H1N1, Rhinovirus and SARS-CoV-2.
Empatica says it’s working on obtaining the FDA’s OK for Aura after having partnered with HHS and Stanford University on validating Aura on U.S. healthcare workers.