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# FDA Clears Empatica’s Pediatric Epilepsy Smartband
- URL: https://www.fdaweb.com/fda-clears-empaticas-pediatric-epilepsy-smartband/
- Published: 2019-01-08T12:00:00.000Z
- Updated: 2026-09-15T00:52:49.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5143103

FDA has cleared an Empatica 510(k) for its Embrace, a pediatric epilepsy smartband that detects patterns in motion and physiological signals that may be associated with generalized tonic-clonic seizures, and immediately alerts caregivers. The company says it is the first non-EEG based physiology signal seizure monitoring system to be cleared by the agency for use in the pediatric population. Clearance was based on data from clinical testing carried out in an epilepsy monitoring unit among 141 patients (80 pediatric patients aged 6-21 years) diagnosed with epilepsy. Data demonstrated that 53 out of 54 generalized tonic-clonic seizures were detected by Embrace (98% accuracy rate), according to Empatica. In 1/2018, [Embrace received FDA clearance for seizure monitoring in adults](https://www.prnewswire.com/news-releases/embrace-by-empatica-is-the-worlds-first-smart-watch-to-be-cleared-by-fda-for-use-in-neurology-300593398.html?ref=fdaweb.com).