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# FDA Clears Empatica’s Watch Monitor for Seizures
- URL: https://www.fdaweb.com/fda-clears-empaticas-watch-monitor-for-seizures/
- Published: 2018-02-07T12:00:00.000Z
- Updated: 2026-09-14T23:20:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140711

FDA has cleared an Empatica 510(k) for Embrace, a smart watch that monitors for seizures known as “grand mal” or “generalized tonic-clonic” seizures. Once detected, the watch sends an alert to summon a caregiver for help. The device measures multiple seizure indicators. It uses “electrodermal activity,” a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, also known as the “fight or flight” response.

Clearance was based on data from a 135-patient multi-site clinical study. “From these patients, 6,530 hours of data were recorded over 272 days, including 40 generalized tonic-clonic seizures,” the company says. “Embrace’s algorithm was shown to detect 100% of the seizures.”