{"id":61328,"date":"2025-05-28T10:03:14","date_gmt":"2025-05-28T08:03:14","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/empatica-achieves-ce-mdr-certification-for-epimonitor-bringing-round-the-clock-epilepsy-monitoring-to-europe\/"},"modified":"2025-05-28T10:03:14","modified_gmt":"2025-05-28T08:03:14","slug":"empatica-achieves-ce-mdr-certification-for-epimonitor-bringing-round-the-clock-epilepsy-monitoring-to-europe","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/empatica-achieves-ce-mdr-certification-for-epimonitor-bringing-round-the-clock-epilepsy-monitoring-to-europe\/","title":{"rendered":"Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe"},"content":{"rendered":"
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BOSTON–(BUSINESS WIRE)–Following its successful US launch and FDA clearance, Empatica is proud to announce that EpiMonitor<\/a>, its pioneering epilepsy monitoring solution, is now a CE-certified device according to EU Medical Device Regulation 2017\/745 and available in Europe. EpiMonitor is a game-changing, medical-grade wearable and app combination that revolutionizes epilepsy care, providing seizure detection and alerting alongside continuous health monitoring capabilities also used in clinical research settings.<\/p>\n

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\nEpiMonitor comprises the sophisticated EmbracePlus watch and a companion smartphone app. EpiMonitor\u2019s algorithm continuously analyzes user data, looking for patterns that may resemble a generalized tonic-clonic seizure, and sends automated alerts to caregivers with scientifically proven 98% accuracy. EpiMonitor also offers a detailed sleep, activity, and seizure diary, providing people with epilepsy and their doctors with important information to make empowered decisions on their health journey.<\/p>\n

\nEpiMonitor is now available in Germany, France, Italy, Spain, Denmark, Sweden, Belgium, Luxembourg, Austria, Liechtenstein, Ireland, the Netherlands, Malta, and Finland. The EpiMonitor app is also available in all local languages for a seamless experience for its users.<\/p>\n

\n\u201cEpiMonitor\u2019s availability in Europe is a great milestone for the epilepsy community,\u201d said Simone Tognetti, Empatica\u2019s CTO & Co-founder. \u201cOur goal is to continue bringing technology that improves lives to more people around the world. EpiMonitor is the world\u2019s only non-invasive, medical-grade wearable for night and day epilepsy monitoring, and our rigorous engineering methods and quality processes guarantee unmatched safety and accuracy. With EpiMonitor, we have taken the best of our previous wearables and amplified it in a solution that uses our most innovative and powerful technology, alongside algorithms that provide detailed and meaningful health insights. We didn\u2019t want to make just another health tracker, but to provide a lifeline for the millions of people living with epilepsy around the world.\u201d<\/p>\n

\nKey features of EpiMonitor include:<\/p>\n