Empatica Achieves CE MDR Certification for EpiMonitor, Bringing Round-the-Clock Epilepsy Monitoring to Europe

Following its successful US launch and FDA clearance, Empatica is proud to announce that EpiMonitor, 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.

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EpiMonitor comprises the sophisticated EmbracePlus watch and a companion smartphone app. EpiMonitor’s 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.

EpiMonitor 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.

“EpiMonitor’s availability in Europe is a great milestone for the epilepsy community,” said Simone Tognetti, Empatica’s CTO & Co-founder. “Our goal is to continue bringing technology that improves lives to more people around the world. EpiMonitor is the world’s 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’t want to make just another health tracker, but to provide a lifeline for the millions of people living with epilepsy around the world.”

Key features of EpiMonitor include:

• Fully medical-grade technology consisting of a wearable and app
• Automatic generalized tonic-clonic seizure detection and alerts to caregivers (98% accuracy; low False Alarm Rate)
• Ability for users to send self-triggered alerts to caregivers
• Up to 7 days of battery life
• A user-friendly mobile app with a detailed, automated diary
• Daily sleep and activity tracking through Empatica’s algorithms
• Detailed reports that can be exported and shared with a doctor
• High accessibility with app translations in 8 languages
• Compatibility with iOS and Android smartphones

Empatica has been the market leader in providing the world’s only medical watches for people living with epilepsy for nearly a decade. Epilepsy affects 6 million people in Europe, with approximately 15% of those being children. Studies indicate that up to 40% of epilepsy cases are difficult to treat, and a third of people with epilepsy are refractory to current medications. Sudden Unexpected Death in Epilepsy (SUDEP) is the number one cause of epilepsy-related deaths in people with pharmacoresistant epilepsy. Most SUDEP deaths occur when a generalized tonic-clonic seizure occurs during sleep.

EpiMonitor can be purchased directly from the Empatica website. To learn more visit empatica.com/epimonitor.

Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. Empatica's platform and technology are used by thousands of institutional partners for research purposes, in studies examining stress, sleep, epilepsy, migraine, depression, addiction, and other conditions. In 2018, Empatica’s Embrace wearable received FDA clearance for seizure monitoring, making it the world's first epilepsy watch to be cleared by the FDA. Its successor, EpiMonitor, launched in the US in 2024 after receiving FDA clearance. Empatica’s flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and NASA.

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