Update: Embrace is Now an FDA-cleared Medical Device!
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 a wearable that measured electrodermal activity (EDA).
During one of these studies, she discovered that such body signal could be accurately used for seizure detection. More research was later done at Boston Children’s Hospital, and in 2014 the Empatica Team began a series of studies at several epilepsy centers, certified as Level IV by the National Association of Epilepsy Centers (NAEC).
These studies contributed to the development of our seizure detection algorithm using Artificial Intelligence methods to recognize complex physiological patterns in EDA, that are most likely to accompany a convulsive seizure.
As more data was gathered, our data scientists have continued to work on improving the algorithm for seizure classification, and they keep working relentlessly on more clinical results in Epilepsy and human behavior.
All our efforts came to fruition on January 26, 2018, when we received word from the FDA that our application had been cleared.
This is a profound achievement for the epilepsy community at large, and it’s the first time a smart watch has been cleared within the field of Neurology.
We wouldn’t be here without our community of steadfast supporters who have kept us willing to improve throughout the years. We sincerely thank you for your trust, love and support and promise to keep working with all our heart on revolutionary technology that can improve and save lives.
Should you wish to read more on the announcement, click here
A big hug,
The Empatica Team