Empatica First to Win CE Mark For Wearable-Based Early Symptoms Detection of COVID-19

Digital biomarker and medical device company Empatica secured the CE mark for its Aura system, a...

Empatica’s smartwatches are CE-certified and FDA-cleared, and come complete with custom-made sensors for the utmost accuracy. Photo credit: Empatica

Digital biomarker and medical device company Empatica 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.

Read more: Empatica And BARDA Team Up To Validate Wearable Early Warning System For COVID-19

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.

COVID-19 already has resulted in millions of deaths globally, while other respiratory infections caused by influenza-like pathogens kill between 250k and 500k people and cost up to $167 billion annually.

Empatica CEO, Matteo Lai stated: "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."

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. Contact care@empatica.com to learn more.

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.

Read more: Empatica’s Embrace Plus Smartwatch Will Monitor Health of Astronauts Aboard Mars Mission

Empatica, an MIT-spinoff based in Boston, MA, and Milan, Italy, is a pioneer in digital biomarker development and continuous patient monitoring driven by AI. Empatica's smartwatches are FDA cleared and CE-marked and have been sold to thousands of institutional partners for clinical trials and research, in studies examining depression, addiction, stress, oncology, epilepsy, migraine, and numerous other conditions.

Sam Draper
March 25, 2021

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