Wearable med device firm Empatica said today it won FDA clearance for its Embrace seizure-tracking wristband.
The Embrace device is designed to detect and monitor stress signals and detect seizures that could potentially be deadly, the Cambridge, Mass.-based company said.
The wrist-worn Embrace looks like a fitness tracker and is equipped with temperature sensors to detect changes in body heat, gyroscopes and accelerometers to detect movement and an EDA sensor to detect electric changes in the skin. The system also uses advanced machine learning to monitor for grand mal seizures and sends alerts to caregivers.
“It’s been quite the journey – we have worked for years building wearable stress and emotion sensors, and then accidentally discovered we could pick up changes in the skin elicited by brain activity related to the most dangerous kinds of seizures. It has been very meaningful to see this technology move from the lab into the most accurate, beautiful and easy to use sensor on the market,” Empatica chief scientist Rosalind Picard said in a press release.
“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,” co-founder & CEO Matteo Lai said in prepared remarks.
Approval of the device came based on data from a 135-patient, multi-center trial of patients with epilepsy who were admitted to top level IV epilepsy monitoring units for continuous monitoring with video-EEG, as well as the Empatica. A total of 6,350 hours of data were used in the trial, including data from 40 generalized tonic-clonic seizures.
Empatica said the algorithms behind the Embrace device were able to detect 100% of seizures, and that the trial compared seizures clinically labeled by at least two out of three independent epileptologists who examined video-EEG data without seeing any data used by Embrace.
“The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients. Tragically, more than 3000 Americans die each year from Sudden Unexpected Death in Epilepsy 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,” NYU Comprehensive Epilepsy Center director Orrin Devinsky said in a prepared statement.
The Embrace system won CE Mark approval in the European Union in April 2017, the company said.