Empatica announced today that it received CE mark approval for its EpiMonitor epilepsy monitoring solution.
EpiMonitor, a medical-grade combination of a wearable and app, aims to revolutionize epilepsy care. It provides seizure detection and alerts alongside continuous health monitoring capabilities also used in clinical research settings.
The system features the EmbracePlus watch with its companion smartphone app, plus an algorithm that continuously analyzes user data. It looks for patterns that may resemble a generalized tonic-clonic seizure and sends automated alerts to caregivers. Empatica touts 98% scientifically proven accuracy.
EpiMonitor also features detailed sleep, activity and seizer data, providing information to make decisions along the health journey.
Empatica said that, with CE mark, it now offers the system in Germany, France, Italy, Spain, Denmark, Sweden, Belgium, Luxembourg, Austria, Liechtenstein, Ireland, the Netherlands, Malta and Finland. The app comes in all local languages as well. EpiMonitor already has FDA approval and commercial availability in the U.S.
“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.”
