Embrace by Empatica has received 510(k) clearance from the 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.
This clearance represents a significant advancement in expanding availability to this cutting-edge seizure monitoring technology for families living with epilepsy. It is a fantastic piece of news to start 2019 for the global epilepsy population, as it means parents now have easy access to an officially clinically validated technology. The clearance for children is not only a positive development for families, but also for doctors, providing them with reliable technology that can assist in patient treatment and care.