Seizure detection smartwatch receives FDA clearance

Empatica Inc. has received FDA clearance for Embrace, an artificial intelligence (AI)-powered smartwatch capable of detecting seizures.

"The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients,” said Orrin Devinsky, an expert in epilepsy and Director of the Comprehensive Epilepsy Center at NYU. “Tragically, more than 3000 Americans die each year from Sudden Unexpected Death in Epilepsy (SUDEP) and the Embrace offers the potential to alarm family members and caretakers that a tonic-clonic seizure is occurring. The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases."

By using electrodermal activity (EDA), the signal used to quantify physiological changes related to sympathetic nervous system activity, the smartwatch measures multiple indicators of a seizure. The Embrace smartwatch was tested in a study of 135 epilepsy patients to assess its feasibility and impact for continuous monitoring grand mal seizures. Patients were monitored with video-EEG while also wearing the smartwatch. A total of 6,530 hours of data were collected over 272 days that included 40 seizures. Results showed the smartwatch was able to detect 100 percent of the seizures.

"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,” said Matteo Lai, Co-Founder and CEO of Empatica. “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."