Empatica’s “Embrace” Device Becomes First Smartwatch to Receive FDA Approval

Empatica, a wearable device company founded by Italian Endeavor Entrepreneur Matteo Lai, has received FDA clearance for its epilepsy-monitoring “Embrace” smartwatch. The Embrace is the first smartwatch to receive FDA clearance, and is approved for use in neurology.

The Embrace device uses artificial intelligence to monitor seizures and send an alert to summon caregivers’ help. It also provides sleep, rest, and physical activity analysis. Embrace stands apart from any seizure detection system in that it measures multiple indicators of a seizure. Its unique property is its use of Electrodermal Activity (EDA), a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, also known as the “fight or flight” response. Embrace had already been approved in Europe as a medical device for seizure monitoring and alert since April 2017.

Embrace is a smart watch for Epilepsy Management which uses advanced machine learning to identify convulsive seizures and send alerts to caregivers. It also provides sleep, rest, and physical activity analysis. (PRNewsfoto/Empatica)

According to recent estimates, 1.2% of the US population suffers from epilepsy, amounting to around 3.4 million patients, including 470,000 children. Around 35% of these patients do not respond to medication to control their seizures, while another third is only partially responsive to medication.Embrace’s high sensitivity makes seizure reporting easier and more accurate. The bracelet also sends an alert immediately to a caregiver, to bring help at the time of need.

The field has been waiting for decades for a biomarker alternative to wearing an EEG, that can be automated, used outside of the hospital, and isn’t bulky or cumbersome to wear.

Empatica Founder Matteo Lai (left). Photo by Kieran Kesner for Endeavor

Empatica initially launched Embrace through a crowdfunding campaign in 2015, focusing heavily on high-quality design. According to Matteo Lai, Co-Founder and CEO of Empatica, “Medical devices face a huge problem: they’re usually too bulky and uncomfortable, and people simply don’t want to wear them. Empatica took a different path. We wanted to design the world’s first medical device that could win a design award, while being used as a lifesaving product. Patients actually love Embrace and are proud to wear it. We think this has been one of the keys of its success and an interesting lesson for healthcare. Cutting edge technology and good design need to go together.”

Matteo was selected as an Endeavor Entrepreneur at the 66th International Selection Panel in Boston in 2016. Endeavor Italy has supported Matteo as he has worked to scale Empatica, connecting him with mentors in the industry and helping make introductions to investors. In April 2017, Empatica also received investment from Endeavor Catalyst.

Read more about the device and this milestone here.