29 Feb 2024

Empatica launches FDA-cleared epimonitor for epilepsy with AI seizure forecasting study

Empatica has launched EpiMonitor, an FDA-cleared wearable solution for epilepsy monitoring, representing a significant advancement from its predecessor, Embrace2. EpiMonitor utilises the next-generation medical watch, EmbracePlus, offering enhanced capabilities such as new seizure alert features, up to a week of battery life, and advanced health insights. The device, cleared for adults and children aged 6 and up, employs a smart algorithm with a 98% accuracy rate for automatic seizure detection and alerts caregivers via call and SMS with the user's location. EpiMonitor also features a user-friendly mobile app, sleep and activity tracking, and the option to send self-triggered alerts to caregivers.


The FDA clearance for EpiMonitor is a milestone for Empatica, showcasing successful integration with its existing technology stack and potential to host future Software as a Medical Device (SaMD) products. Additionally, Empatica has initiated a groundbreaking study for seizure forecasting based on the world's largest real-world dataset in epilepsy patients. 


Users of EpiMonitor can enrol in the study, contributing valuable data to advance personalised seizure forecasting, aiming to improve clinical outcomes and quality of life for individuals with epilepsy. The study seeks to overcome challenges associated with gathering large datasets, with the ultimate goal of tailoring therapies, enhancing seizure management, and providing useful information for modifying daily activities. 


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