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    Home ยป Empatica Receives CE Mark Approval for EpiMonitor Epilepsy Monitoring System
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    Empatica Receives CE Mark Approval for EpiMonitor Epilepsy Monitoring System

    techgeekwireBy techgeekwireMay 28, 2025No Comments2 Mins Read
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    Empatica’s EpiMonitor Receives CE Mark Approval for European Markets

    Empatica has announced that its EpiMonitor epilepsy monitoring solution has received CE mark approval, making it available in multiple European countries. The EpiMonitor system, featuring the EmbracePlus watch and a companion smartphone app, is designed to detect seizures and provide continuous health monitoring.

    The EpiMonitor system
    The system uses advanced algorithms to analyze user data and identify patterns that may indicate a generalized tonic-clonic seizure, sending automated alerts to caregivers. Empatica reports a scientifically proven accuracy rate of 98% for the EpiMonitor.

    The EpiMonitor is not just a seizure detection device; it also provides detailed data on sleep, activity, and seizure occurrences. This comprehensive health monitoring capability is designed to help individuals with epilepsy and their healthcare providers make informed decisions about their care.

    With the CE mark approval, EpiMonitor is now available in 14 European countries, including Germany, France, Italy, and Spain. The companion app is available in all local languages, making it more accessible to a broader user base.

    This development follows EpiMonitor’s previous FDA approval and commercial availability in the United States. “EpiMonitor’s availability in Europe is a great milestone for the epilepsy community,” said Simone Tognetti, Empatica’s CTO and co-founder. “Our goal is to continue bringing technology that improves lives to more people around the world.”

    The EpiMonitor represents a significant advancement in epilepsy care, offering a non-invasive, medical-grade wearable solution for both night and day monitoring. Empatica emphasizes that the system’s development was guided by rigorous engineering methods and quality processes to ensure safety and accuracy.

    CE mark approval Empatica epilepsy monitoring EpiMonitor medical technology Wearable Devices
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