www.fdanews.com/articles/185529-fda-clears-first-of-its-kind-smart-watch-for-epilepsy-management
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FDA Clears First-of-its-Kind Smart Watch for Epilepsy Management
February 7, 2018
Massachusetts-based devicemaker Empatica obtained FDA 510(k) clearance for its Embrace smart watch intended to aid patients with epilepsy management.
The first-of-its-kind FDA-cleared wearable uses machine learning technology to monitor patients to detect dangerous, convulsive seizures and alert caregivers to provide clinical assistance.
Embrace also offers analyses of sleep, rest, and physical activity.