Empatica has secured CE mark approval for its EpiMonitor system, a wearable seizure detection and health monitoring solution for people living with epilepsy.
EpiMonitor combines the EmbracePlus smartwatch, a companion mobile app, and an AI algorithm to detect generalized tonic-clonic seizures with 98% proven accuracy, sending real-time alerts to caregivers. The system also tracks sleep, activity, and seizure patterns for continuous care insights.
With this regulatory milestone, EpiMonitor is now available in 14 European countries, including Germany, France, Italy, and Spain, with support in all local languages. It is already FDA-approved and commercially available in the U.S.
Empatica positions EpiMonitor as the only non-invasive, medical-grade wearable offering 24/7 epilepsy monitoring.
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