USA – Seizure Monitoring Smartwatch Cleared for Use in Children

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…