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Epilepsy smartband gets FDA approval
10 January 2019 | News
It is the first non-EEG based physiology signal seizure monitoring system
Embrace by Empatica has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in children. Embrace is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers.
It is the first non-EEG based physiology signal seizure monitoring system to be cleared by the FDA for use in a pediatric population, highlighting the challenges and complicated processes that come with this type of testing for children.
The clearance for children is not only positive development for families, but also for doctors, providing them with reliable technology that can assist in patient treatment and care.
