Empatica's COVID-detecting wearable nets European approval

The makers of a wearable device designed to automatically detect epileptic seizures and call for help have their eyes set on COVID-19—with a newly obtained approval in Europe for a device that detects respiratory infections before symptoms appear. 

Empatica’s wrist-worn Aura system passively collects data from the wearer, including on their heart rate, pulse variability and the electrical activity of their skin, to spot the small changes that occur when the body’s immune system is fighting off a viral intruder.

The device, along with the company’s digital monitoring platform and smartphone app, received a first-of-its-kind CE mark allowing it to be sold in the European Union. The system automatically alerts the wearer—from ages 14 and up—and can optionally inform their healthcare provider or caregivers if an infection is suspected.

"Our goal with Aura was to create an effective, scalable and affordable tool for screening infection risk and supporting testing efficiency, all while monitoring people's health remotely,” Empatica CEO Matteo Lai said. “We hope Aura can play an important role in controlling new outbreaks and helping people safely get back to work and to a normal life."

Even with the advent of vaccines, some expect the virus to become endemic, with early alert systems playing a key role in containing new outbreaks of the disease.

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In studies, the device correctly detected 94% of participants with a possible infection, within two days on average, including signs and symptoms linked to the pandemic coronavirus, rhinoviruses and the H1N1 swine flu.

Empatica, originally launched as an MIT spinoff, has also partnered with Stanford University and the U.S. Biomedical Advanced Research and Development Authority, also known as BARDA, to evaluate the Aura device for eventual FDA review.