Empatica said that its Embrace epilepsy smartband has received 510(k) clearance from FDA for use in children, a year after winning clearance for adults with epilepsy.
Embrace was designed to detect motion patterns and physiological signals that may be associated with generalized tonic-clonic (“grand mal”) seizures and immediately alert caregivers. It is the first non-EEG based, physiology-signal seizure monitoring system that FDA has cleared for use in a pediatric population, according to the Cambridge, Mass. company.
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