Empatica announced the official launch of EpiMonitor, the latest advancement in wearable epilepsy monitoring.
EpiMonitor has been FDA cleared for use in adult and children populations aged 6 and up, and is the only wearable solution with regulatory approval for seizure detection available to purchase in the U.S. It is the successor to Embrace2, a wearable for seizure detection.
EpiMonitor represents a leap forward in epilepsy monitoring technologies, thanks to enhanced capabilities including new seizure alert features, up to a week of battery life, and advanced health insights. It utilizes Empatica’s next-generation medical watch, EmbracePlus, which has already been successfully used to monitor the health of thousands of participants in hundreds of clinical trials. Together with a companion smartphone app and smart algorithms, EpiMonitor is a complete system that continuously monitors its wearer’s health data, detecting possible generalized tonic-clonic seizures, alerting caregivers, and providing valuable health information to help users better manage their condition.
Key features of EpiMonitor include:
- FDA-cleared for adults and children ages 6 and up
- Automatic seizure detection through a smart algorithm (98% accuracy; low False Alarm Rate) and alerts to caregivers via a call and SMS with the user’s location
- Up to 7 days of battery life
- Advanced sensor technology for accurate data collection
- Option to send self-triggered alerts to caregivers
- A user-friendly mobile app with a seizure diary
- Sleep and activity tracking through Empatica’s algorithms
- Seizure, sleep and activity reports that can be exported and shared with a physician
- iOS and Android compatibility
The EpiMonitor FDA clearance also represents a significant milestone for Empatica as it demonstrates the successful integration of a new algorithm with the existing technology stack of the Empatica Health Monitoring Platform, highlighting its potential to host future SaMD products.
