Research & Development
Empatica wins first of its kind US FDA clearance for Embrace for children diagnosed with epilepsy
9 January 2019 -

Medical research device company Empatica reported on Tuesday the receipt of the 510(k) clearance from the US Food and Drug Administration (FDA) for Embrace for use in paediatric patients with epilepsy.

Empatica added that Embrace is an epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalised tonic-clonic seizures and immediately alerts caregivers. It is the US FDA's first non-EEG based physiology signal seizure monitoring system for paediatric use.

Based on the data from the clinical testing in an Epilepsy Monitoring Unit (EMU) among 141 patients diagnosed with epilepsy, about 80 of them were paediatric patients and 61 were adults. About 53 out of 54 generalised tonic-clonic seizures were detected by Embrace for an accuracy rate of 98% during the clinical testing, with the overall FAR for adults being 0.67 and the one for paediatrics being 1.35.

In April 2017, Embrace was CE certified in Europe as a medical device for seizure detection. Embrace has been listed as one of the 18 things that made the world a better place in 2018 by WIRED.

About 25% of all people with epilepsy have generalised tonic-clonic seizures, which are most commonly associated with SUDEP (Sudden Unexpected Death in Epilepsy).

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