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Home » Empatica wins CE mark for wearable-based early symptoms detection of COVID-19
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Empatica wins CE mark for wearable-based early symptoms detection of COVID-19

March 10, 2021
By Meg Bryant
MIT Media Labs spinoff Empatica Inc. secured the CE mark for its Aura system, a wearable solution for the monitoring and early alert of respiratory infections, including COVID-19. For use with people 14 and older, Aura is commercially available in Europe and the U.K., and for pilot purposes in the U.S. – pending FDA authorization. Aura’s algorithm analyzes vital signs from Empatica smartwatches, comparing data against the wearer’s historical baselines. In validation studies, Aura was able to detect patients with possible H1N1 influenza, rhinovirus or SARS-CoV-2 infection with 0.94 sensitivity. Detection occurred on average two days after infection.
BioWorld MedTech Regulatory Respiratory Coronavirus Diagnostics Artificial intelligence Digital health Wearable Algorithm Mobile/smartphone app Europe

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