First of Its Kind Product Receives CE-Marking for Respiratory Infection Detection Using Smart Wearable Technology

A first of its kind product has received CE-marking for the detection of respiratory infection, including COVID-19, using smart wearable technology.

Empatica (Boston, MA, USA) has been awarded CE-certification for its Aura system to detect and alert to respiratory infections, including COVID-19, early and before visible symptoms appear. Empatica has received its CE mark as a Class lla medical device, meaning that Aura, as well as its remote health monitoring platform, Care, meet safety and performance requirements in Europe. This makes Aura the first product of its kind to receive CE-marking for respiratory infection detection using smart wearable technology.


Aura's algorithm analyzes vital signs from Empatica's smartwatches, comparing data against historical baselines unique to each wearer. Requiring no manual input, when changes in a user's data suggest their body is beginning to fight an infection, Aura automatically displays a warning to Empatica's smartphone-based Care App, as well as to the cloud-based Care Portal, optionally informing their healthcare provider or caregivers. Through the Care Portal, healthcare professionals can simultaneously monitor the risk status of hundreds of individuals remotely, making Aura a powerful tool for maintaining healthy communities and preventing outbreaks.

In validation studies, Aura showed a sensitivity of 0.94 for detecting patients with a possible infection. Detection happened on average two days after viral inoculation. The results apply to general physiological responses that arose from three different viruses: H1N1, Rhinovirus, and SARS-CoV-2. Aura, for use in ages 14 and up, is now available across Europe and the UK for healthcare providers and other professionals seeking to contain the spread of infectious diseases within their communities. Empatica, in the process of gaining FDA-approval for Aura, has partnered with the US Department of Health and Human Services (via the Biomedical Advanced Research and Development Authority) and Stanford University to run a nationwide validation study with US-based healthcare workers.

"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. This result is a win for science and technology against the COVID-19 pandemic. 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," said Empatica CEO, Matteo Lai.

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