We’re beyond excited to announce that the Embrace Watch has been cleared by the U.S. Food and Drug Administration as a medical device! This marks an invaluable milestone in our mission towards improving lives for millions of people in the epilepsy community.
We feel incredibly proud to have met FDA’s requirements, which are considered to be the most rigorous among all healthcare regulatory bodies around the world.
We started with the filing work in mid-2016, and our final package reached 1,500 pages, where we’ve presented the scientific evidence and technical details around the Embrace system.
Seizure monitoring research had started in 2007 at the MIT Media Lab with Dr. Rosalind Picard — Director of the Affective Computing Group and Chief Scientist at Empatica, who began working on .
