Empatica just announced that it is now validated as a medical product in the EU (CE Mark, Class II a) (This is the European equivalent of FDA; the FDA is still considering the system and usually takes a lot longer than the EU).
The Empatica AURA tells you if your physiological patterns indicate you are fighting an infection like flu (H1N1 or rhinovirus) or coronavirus (covid-19), even if you aren’t showing any fever, cough, or other clear symptoms of being sick.
This also makes Empatica the first to receive the European CE mark for detecting early symptoms of COVID-19 using wearables.
This makes Aura the first product of its kind to receive CE-marking for respiratory infection detection using smart wearable technology.
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 from three different viruses: H1N1, Rhinovirus, and SARS-CoV-2.
For use in ages 14 and up, Aura 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 is 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. They 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.
The co-founder, Rosalind Picard, is also currently a professor at the MIT media Lan and a co-founder of Affectiva that specializes in using AI-based solutions for In lab biometric research, automotive AI, and media analytics.