The Food and Drug Administration (FDA) has granted 501(k) clearance to the Embrace watch for use in epilepsy patients aged ≥6 years. The smartwatch identifies certain motion and physiological signals associated with generalized tonic-clonic seizures and promptly alerts caregivers.
First approved in January 2018 for adults (aged ≥21 years), the watch uses an electrodermal activity sensor to measure sympathetic nervous system activity. The latest approval makes it the first non-EEG based physiology signal seizure monitor to be cleared for use in pediatric patients.
A clinical test was conducted among 141 epilepsy patients, of which 80 patients were aged 6 to 21 years and 61 patients were aged >21 years. The data demonstrated an accuracy rate of 98% (53 out of 54) for detecting generalized tonic-clonic seizures. The overall false alarm rate (FAR) for adults was 0.67 and 1.35 for pediatrics.
“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,” said Empatica co-founder and MIT professor Rosalind Picard.
For more information visit Empatica.com.