Europe gains access to non-stop epilepsy monitoring with Empatica's EpiMonitor certification under MDR CE.
In a significant development, Empatica's groundbreaking epilepsy monitoring solution, EpiMonitor, has secured CE certification, making it available for use across the European Union. The medical-grade wearable and app combination revolutionizes epilepsy care by providing real-time seizure detection and alerts, along with continuous health monitoring capabilities.
EpiMonitor consists of the EmbracePlus smartwatch and a companion app. The system's algorithm continuously analyses user data for patterns resembling a generalized tonic-clonic seizure, sending automatic alerts to caregivers with an accuracy of 98%. In addition, the app features a detailed seizure, sleep, and activity diary, providing valuable insights for epilepsy patients and their healthcare providers.
Now open for sales in Germany, France, Italy, Spain, Denmark, Sweden, Belgium, Luxembourg, Austria, Liechtenstein, Ireland, the Netherlands, Malta, and Finland, the EpiMonitor app is available in all local languages for a seamless experience. The device's key features include a user-friendly app, up to 7 days of battery life, and strong compatibility with iOS and Android smartphones.
Simone Tognetti, Empatica's CTO and Co-founder, emphasized the significance of EpiMonitor's availability in Europe: "This marks a great milestone for the epilepsy community, as our aim is to bring technology that improves lives to more people around the world. By offering the world's only non-invasive medical-grade wearable for day and night epilepsy monitoring, we hope to empower both people with epilepsy and their doctors, providing a lifeline for the millions affected by this condition."
EpiMonitor addresses an essential need, as epilepsy affects approximately 6 million individuals in Europe, with around 15% of these being children. Studies suggest that up to 40% of epilepsy cases are difficult to treat, and a third of sufferers are refractory to current medications. SUDEP, or Sudden Unexpected Death in Epilepsy, is the primary cause of epilepsy-related fatalities in people with pharmacoresistant epilepsy, often occurring during sleep.
EpiMonitor can be purchased directly from Empatica's website. Further information is available at empatica.com/epimonitor. Empatica, a pioneer in continuous, unobtrusive remote health monitoring driven by AI, has been a market leader in epilepsy care for nearly a decade. Its flagship medical wearable, EmbracePlus, has collaborated with key partners including HHS, USAMRDC, and NASA.
For media inquiries, contact Marianna Xenophontos ([email protected]).
- The EpiMonitor, a revolutionary medical-grade wearable and app combination for epilepsy care, is now available for use across the European Union, following its CE certification.
- Beyond seizure detection, the EpiMonitor app offers a comprehensive medical record, featuring a detailed seizure, sleep, and activity diary, benefiting both epilepsy patients and their healthcare providers.
- EpiMonitor, Empatica's reliable solution for day and night epilepsy monitoring, aims to empower individuals with epilepsy and their medical professionals through technology, catering to the essential health needs of approximately 6 million Europeans.
- As advancements in technology continue to positively impact various medical-conditions such as epilepsy, fitness-and-exercise, mental-health, and health-and-wellness, companies like Empatica contribute to a brighter future where cloud-based solutions can be utilized to improve people's lives and reduce technology-related disparities.
