Seizure-Detecting Embrace Smartwatch Approved by FDA

  • 8 February 2018
  • Sam Mire

Those who suffer from epilepsy or other conditions that result in sporadic seizing know the uncertainty that can cast a pall over daily life. Having someone near you that knows how to react when you have a seizure can be somewhat burdensome, if not unrealistic for many. Now, an FDA-approved smartwatch called Embrace will allow those who experience regular seizures to have a constant buddy along with them, residing on their wrist.

The watch, which was developed by Empatica, constantly monitors physiological processes, collecting data about the sympathetic nervous system to detect when an abnormality in the form of a seizure is occurring. Its machine learning means that it is exceptionally good at detecting changes in biomarkers that indicate a seizure. In fact, it’s proven to be perfect.

The FDA approval came after 135 patients with epilepsy were admitted for extensive testing. Utilizing the Embrace watch along with video monitoring technology, 6,530 hours of data were recorded, with the smartwatch detecting 100% of cases in which a seizure occurred.

The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases, said Orrin Devinsky, Director of the Comprehensive Epilepsy Center at NYU.

The 100% detection and logging rate is a stark difference from the current state of affairs, in which an estimated 40% of generalized tonic-clonic seizures are not detected and thus not reported. Embrace’s seizure-detection algorithm looks out for electrodermal activity that tends to accompany both generalized tonic-clonic and grand mal seizures, alerting caregivers via text and call alerts when they occur.

The $249 price point for those with a prescription is a steal considering that over 3,000 Americans alone die from sudden epilepsy-related seizures and over 3 million people in the U.S. have epilepsy. While European authorities approved the device in April 2017, the FDA has now gotten around to allowing it into the American marketplace, saving countless lives as a result.

The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients, Devinsky added.

About Sam Mire

Sam is a Market Research Analyst at Disruptor Daily. He's a trained journalist with experience in the field of disruptive technology. He’s versed in the impact that blockchain technology is having on industries of today, from healthcare to cannabis. He’s written extensively on the individuals and companies shaping the future of tech, working directly with many of them to advance their vision. Sam is known for writing work that brings value to industry professionals and the generally curious – as well as an occasional smile to the face.