Empatica, a Massachusetts Institute of Technology spinoff, received FDA clearance for a wristworn device that uses machine learning to alert people with epilepsy and their caregivers of a convulsive seizure and track their duration and frequency.
Epilepsy affects a least 2.2 million people, according to data from the Epilepsy Foundation.
Empatica’s Emrace device assesses multiple indicators of a seizure, including electrodermal activity, a signal associated with fight or flight response that’s used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, the company statement noted.
In a clinical trial of the device, 135 patients across multiple sites resided at epilepsy monitoring units with continuous monitoring with video-EEG and simultaneously wore an Empatica device. Data collected over 272 days showed that the wearable’s algorithm detected 100 percent of the seizures, according to the company’s statement.
In addition to seizures, the device also tracks sleep and physical activity, according to the company’s website.
The company’s FDA clearance comes nearly one year since its device received regulatory approval in Europe.
Rosalind Picard, the Director of the Affective Computing Group at MIT Media Lab and Chief Scientist at Empatica said in a company statement that “it’s been very meaningful to see this technology move from the lab” into an easy-to-use sensor.
Other companies have developed seizure detection systems, particularly with the goal of sharing the collected data with clinicians so they have a better understanding of their patients’ health between appointments. SmartMonitor developed a smartwatch that detects “irregular shaking” akin to a convulsive seizure. Last month it rolled out a version of its technology in an app for the Apple smartwatch.
The holy grail for people who suffer from seizures would be a device that could warn them ahead of time so that people could avoid potentially putting themselves in harm’s way or take other appropriate action. That’s a longterm goal for Empatica.