Smartwatch for monitoring seizure in kidsMarch 5, 2019
Embrace smartwatch for tracking seizures in children as young as age 6 has been granted marketing approval by USFDA.
The watch uses an electrodermal activity sensor to measure sympathetic nervous system activity. The latest approval has made it the first non-EEG based physiology signal seizure monitor to be cleared for use in paediatric patients. The Embrace was previously approved in January 2018 for adults aged =21 years.
The smartwatch identifies certain motion and physiological signals associated with generalized tonic-clonic seizures and promptly alerts caregivers. The Alert App immediately sends a call and SMS to your caregivers when Embrace detects patterns that may be associated with a convulsive seizure.
Embrace bagged the marketing rights after the positive results of a clinical test which was conducted among 141 epilepsy patients, out 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% for detecting generalized tonic-clonic seizures. The overall false alarm rate (FAR) for adults was 0.67 and 1.35 for paediatrics, Empatica Inc said.