Testing showed accuracy rate of 98 percent
The U.S. Food and Drug Administration (FDA) has cleared the Embrace smartwatch (Empatica Inc.) for seizure tracking in children as young as age six.
The Embrace smartwatch detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. It was approved by the FDA for use in adults last February.
“The clearance of the Embrace watch to detect seizures in children ages 6 years and older is an important step forward in our ability to identify seizures rapidly and thereby allow parents or others to respond,” said Orrin Devinsky, MD, director at NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery.
Of the 3 million-plus people in the United States with epilepsy, about 300,000 are children under the age of 14. Tonic-Clonic seizures, which are most associated with sudden death, occur in about one-quarter of people with epilepsy.
Embrace was tested in an epilepsy monitoring unit among 141 epilepsy patients, including 80 pediatric patients ages 6 to 21 years. Overall, 53 of 54 generalized tonic-clonic seizures were detected by Embrace for an accuracy rate of 98% during the clinical testing.