Empatica Launches CE-Certified EpiMonitor in Europe, Offering 24/7 Epilepsy Monitoring and Alerts

Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Continuous Epilepsy Monitoring to Europe BOSTON—(BUSINESS WIRE)—Following its successful launch and FDA clearance in the United States, Empatica is pleased to announce that EpiMonitor, its advanced epilepsy monitoring solution, has now achieved CE certification under EU Medical Device Regulation 2017/745 and is available across Europe. EpiMonitor is a groundbreaking medical-grade wearable and app system designed to transform epilepsy care by providing highly accurate seizure detection and continuous health monitoring, which is also utilized in clinical research. EpiMonitor consists of the EmbracePlus watch and a complementary smartphone app. The device’s algorithm continuously analyzes user data, identifying patterns indicative of generalized tonic-clonic seizures, and automatically sends alerts to caregivers with a scientifically validated accuracy of 98%. Additionally, EpiMonitor offers a comprehensive sleep, activity, and seizure diary, enabling individuals with epilepsy and their healthcare providers to make informed decisions about their health. “EpiMonitor’s availability in Europe represents a significant achievement for the epilepsy community,” said Simone Tognetti, Empatica’s CTO and Co-founder. “Our mission is to bring life-improving technology to as many people as possible. EpiMonitor stands out as the world’s only non-invasive, medical-grade wearable capable of monitoring epilepsy both day and night. Rigorous engineering and quality processes ensure unparalleled safety and precision. We sought to create a device that not only tracks health metrics but serves as a critical lifeline for those managing epilepsy.” EpiMonitor is now available in several European countries, including Germany, France, Italy, Spain, Denmark, Sweden, Belgium, Luxembourg, Austria, Liechtenstein, Ireland, the Netherlands, Malta, and Finland. The app supports all local languages, ensuring a seamless and user-friendly experience. EpiMonitor builds upon Empatica's legacy as a leader in medical wearables for epilepsy. The company has been at the forefront of this field for nearly a decade, addressing the needs of over 6 million Europeans affected by epilepsy, including approximately 15% who are children. Research shows that up to 40% of epilepsy cases are challenging to manage, and about one-third of patients are resistant to current treatments. Sudden Unexpected Death in Epilepsy (SUDEP), particularly prevalent among those with pharmacoresistant epilepsy, is the leading cause of epilepsy-related deaths, often occurring during sleep. Key features of EpiMonitor include: Highly Accurate Seizure Detection: The EmbracePlus watch uses advanced algorithms to detect generalized tonic-clonic seizures with 98% accuracy. Automated Alerts: When a seizure is detected, EpiMonitor instantly alerts designated caregivers via the smartphone app. Comprehensive Health Tracking: The device offers detailed insights into sleep quality, activity levels, and seizure occurrences, helping users and doctors make better-informed decisions. Customers can purchase EpiMonitor directly from the Empatica website. For more information, visit empatica.com/epimonitor. Empatica Inc. is a leader in continuous, unobtrusive remote health monitoring powered by artificial intelligence. Their technology platform and solutions are widely used by institutional partners in various research areas, including stress, sleep, epilepsy, migraine, depression, and addiction. In 2018, Empatica's Embrace wearable became the first epilepsy watch to receive FDA clearance for seizure monitoring. The company's latest product, EpiMonitor, launched in the U.S. in 2024 after securing FDA approval. Empatica's flagship medical wearable, EmbracePlus, has been developed through collaborations with prominent organizations such as the U.S. Department of Health and Human Services (HHS), the U.S. Army Medical Research and Development Command (USAMRDC), and NASA. This partnership underscores the company’s commitment to leveraging cutting-edge technology for medical applications.