Welcome to the future of epilepsy monitoring

The importance of FDA clearance and CE MDR certification
Empatica is proud to have received FDA clearance and CE certification according to the EU Medical Device Regulation 2017/745 for EpiMonitor.
The clearance and certification processes for medical devices involve an extensive and independent review of the clinical data showing that a device is safe and effective, as well as an assessment of testing related to usability and cybersecurity.
Unlike consumer devices offering seizure detection apps, EpiMonitor has undergone rigorous validation and testing, demonstrating a 98% detection accuracy against the gold standard of hospital-based EEG measurement.