The US Food and Drug Administration (FDA) has cleared for marketing the Embrace smart watch (Empatica Inc) for seizure tracking and epilepsy management.
The Embrace smart watch uses advanced machine learning to identify convulsive seizures and sends an alert via text and phone message to caregivers.
Embrace was tested in a clinical study involving 135 patients with epilepsy who were admitted to epilepsy monitoring units for continuous monitoring with video electroencephalography while simultaneously wearing the device, which records electrodermal activity.
Researchers collected 6530 hours’ worth of data over 272 days, including 40 generalized tonic-clonic seizures. Embrace’s algorithm detected 100% of the seizures, confirmed by independent epilepsy experts. The device also records sleep, rest, and physical activity data.
“The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients,” Orrin Devinsky, director of the Comprehensive Epilepsy Center at NYU Langone in New York City, said in a news release from the company.
“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,” Dr Devinsky added.
Embrace was approved in Europe for seizure monitoring and alerts in April 2017.
The US Centers for Disease Control and Prevention estimates that about 3.4 million people in the United States have epilepsy, including 470,000 children.