The FDA cleared marketing for Embrace, a smart watch that helps epilepsy patients and caregivers monitor seizures.
The prescription-only device is the world's first smart watch to be cleared by the FDA for neurology use, developer Empatica stated in a news release.
Embrace uses a seizure detection algorithm to recognize electrodermal activity patterns that are likely to accompany epileptic seizures. It monitors for grand mal or generalized tonic-clonic seizures and alerts caregivers through text and phone.
The device was tested in a clinical study of 135 epilepsy patients who were admitted to multiple epilepsy monitoring units for continuous video electroencephalography (EEG). Over 272 days, researchers collected 6,530 hours of data, including 40 generalized tonic-clonic seizures. Embrace detected 100% of the seizures, which were confirmed by independent epileptologists who made assessments without seeing the Embrace 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, MD, of New York University in New York City said in the news release.
More than 3,000 Americans die each year from Sudden Unexpected Death in Epilepsy (SUDEP), he added. "The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases," he said.
Empatica, a MIT Media Lab spin-off, initially launched Embrace through a crowdfunding campaign in 2015. The company raised $782,666, more than five times its goal.
Embrace is the only FDA-cleared seizure monitoring smart watch that also tracks sleep, stress, and physical activity, the company noted. It has been approved in Europe to monitor seizures since April 2017.
Source: Judy George, MedPage Today