Jan. 15, 2019 -- The FDA has cleared for marketing the Embrace smartwatch for seizure tracking in children as young as age 6.
The Embrace, made by Empatica Inc., detects patterns in motion and signals from the body that may be associated with generalized tonic-clonic seizures and alerts caregivers right away.
It was approved by the FDA for use in adults in February 2018, as reported by Medscape Medical News.
"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," Orrin Devinsky, MD, director of the NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery, said in a news release from the company.
More than 3 million people in the US have epilepsy, including around 300,000 children younger than 14. About a quarter of all people with epilepsy have generalized tonic-clonic seizures, which are most often associated with sudden unexpected death in epilepsy.
Embrace was tested in an epilepsy monitoring unit among 141 epilepsy patients, including 80 pediatric patients ages 6 to 21. Overall, 53 of 54 generalized tonic-clonic seizures were detected by Embrace for an accuracy rate of 98% during the clinical testing.