FDA Clears Epilepsy Smartwatch for Use in Children

Megan Brooks

January 09, 2019

The US Food and Drug Administration (FDA) has cleared for marketing the Embrace smartwatch (Empatica Inc) for seizure tracking in children as young as age 6.

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, 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 at 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 age 14. About one quarter of all people with epilepsy have generalized tonic-clonic seizures, which are most often associated with sudden unexpected death in epilepsy (SUDEP).

"Embrace improves the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens. Having somebody present is associated with better health outcomes," Empatica cofounder, chief scientist, and MIT professor Rosalind Picard, ScD, said in the release.

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.

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