FDA Approves mHealth Wearable for Tracking Epileptic Seizures

The U.S. Food and Drug Administration has approved an mHealth wearable that can detect epileptic seizures and immediately alert care team members.

The Embrace smart device, developed by Cambridge, Mass.-based Empatica, uses machine learning technology to measure electrodermal activity and identify when a user experiences the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, then sends alerts by text message and e-mail to designated caregivers.

Some 3.4 million Americans, including 470,000 children, live with epilepsy, according to the Centers for Disease Control and Prevention. About 35 percent don’t respond to medication to control seizures, according to the National Institutes of Health, while medication is only partially effective for another 33 percent.

FDA approval followed a multi-site clinical study conducted by NYU Langone Medical Center in New York City.

In that study, 135 patients with epilepsy were monitored via video electroencephalography while also wearing the Embrace device. In collecting 6,530 hours' worth of data over 272 days, researchers found that the device accurately identified all 40 generalized tonic-clonic seizures, while also recording sleep, rest and physical activity.

Orrin Devinsky, director of NYU Langone’s Comprehensive Epilepsy Center, said FDA approval of the wearable “represents a major milestone in the care of epilepsy patients.”

"Tragically, more than 3,000 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,” he said in a press release issued by Empatica. “The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases.”

A spin-off of the MIT Media Lab, Empatica launched the Embrace device through a crowdfunding campaign in 2015. The smartwatch builds on seizure monitoring research started at MIT by Rosalind Picard, director of the Affective Computing Group and Empatica’s Chief Scientist, who later moved to Boston Children’s Hospital.

"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,” she said in the press release. “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."

mHealth advocates and researchers see wearables, like activity bands and smartwatches, as a care management tool for people with neurological and movement issues, including epilepsy, Alzherimer’s disease and Parkinson’s disease.

Two years ago, researchers at Johns Hopkins University launched a study combining the Apple Watch with the EpiWatch app on Apple’s ResearchKit platform to track people with epilepsy and study the possible triggers of epileptic seizures.

Reporting to the American Academy of Neurology’s 69^th Annual Meeting in Boston in March 2017, lead researcher Gregory Knauss, MD, said 1,485 seizures, affecting some 40 percent of the group, were tracked over 10 months. When participants were asked what triggered the seizure, 37 percent identified stress, 18 percent reported lack of sleep, 12 percent cited menstruation and 11 percent identified overexertion. Other answers included diet, missed medications and fever or infection.