BOSTON — Empatica has received CE Medical Device Regulation (MDR) certification for its epilepsy monitoring solution, EpiMonitor, clearing the way for its launch across multiple European countries. The announcement marks a major step forward for the company’s mission to provide advanced, around-the-clock seizure monitoring to millions of people living with epilepsy.
Following its FDA clearance and U.S. launch, EpiMonitor is now available in 14 European countries, including Germany, France, Italy, Spain, and the Netherlands. The device is the only wrist-worn, medical-grade wearable and app combination fully cleared for epilepsy monitoring on both sides of the Atlantic.
EpiMonitor consists of the EmbracePlus smartwatch and a companion mobile app. Using continuous biometric analysis, its AI-powered algorithm detects signs of generalized tonic-clonic seizures with 98% accuracy and alerts caregivers in real time. It also tracks key health indicators like sleep, activity, and seizure patterns, compiling data into an accessible, automated diary that can be shared with healthcare providers.
Empatica co-founder and CTO Simone Tognetti said the device was designed not just to monitor health, but to serve as a lifeline. “EpiMonitor’s availability in Europe is a great milestone for the epilepsy community,” he said. “Our goal is to bring technology that improves lives to as many people as possible. With EpiMonitor, we’ve built a solution that provides continuous, non-invasive monitoring with medical-grade reliability. It’s not just another health tracker—it’s a tool that can empower patients and caregivers.”
The EpiMonitor system offers up to seven days of battery life and includes customizable alerts, self-trigger functions, and multilingual support in the app. It’s compatible with both iOS and Android smartphones and designed for ease of use in daily life, while also being robust enough for clinical research applications.
Empatica has been at the forefront of wearable epilepsy technology for nearly a decade. The need for improved epilepsy monitoring remains urgent—epilepsy affects six million people in Europe, with many cases proving resistant to medication. A third of patients do not respond to current treatments, and Sudden Unexpected Death in Epilepsy (SUDEP) remains a leading cause of mortality, particularly during nighttime seizures.
By delivering continuous, real-time seizure detection and comprehensive health tracking, EpiMonitor represents a major advancement in how epilepsy can be managed, both clinically and at home. With CE MDR certification secured, Empatica is now positioned to expand access to its groundbreaking technology across Europe.
