Empatica Initiates AI Seizure Forecasting Study With Debut of Epilepsy Watch

Empatica Inc. has officially launched the EpiMonitor, a U.S. Food and Drug Administration (FDA)-cleared wearable solution designed to detect possible generalized tonic-clonic seizures and monitor epilepsy.

Cleared for use in adult and pediatric populations ages 6 and up, EpiMonitor is the successor to Embrace2, which has been used to detect seizures for years, and was the first ever to be available to patients. The new device features enhanced capabilities including new seizure alert features, up to a week of battery life, and advanced health insights. It uses Empatica’s next-generation medical watch, EmbracePlus, which has successfully monitored 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.
 
“We are thrilled to introduce EpiMonitor to people with epilepsy in the U.S.,” Empatica’s Chief Scientist/Co-founder Dr. Rosalind Picard said. “Empatica has provided the only smartwatch seizure monitors validated by the FDA. EpiMonitor takes this to a new level: giving patients up to seven days of battery life, and new features that give them greater control over seizure alerts. Also, at the touch of a button, patients can now see comprehensive health insights—including seizures, sleep, and activity reports—in a form easy to give their clinician.”
 
Key features of EpiMonitor include 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; advanced sensor technology for accurate data collection; an 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; and iOS and Android compatibility.
 
The EpiMonitor successfully integrates a new algorithm with the existing technology stack of the Empatica Health Monitoring Platform, highlighting its potential to host future SaMD products.
 
In conjunction with the EpiMonitor’s launch, Empatica also is planning to conduct a study to develop a seizure forecasting algorithm based on the world’s largest real-world data set in epilepsy patients. Recruitment for the study is available to all U.S.-based EpiMonitor users. “Our FORESIGHT clinical study is an opportunity to advance personalized seizure forecasting,” Empatica Chief Medical Officer Dr. Marisa Cruz said. “This research is a critical step in our ongoing development of innovative and effective seizure management tools that improve clinical outcomes and quality of life for patients with epilepsy.”
 
Seizure forecasting can have multiple benefits, including early intervention in the form of tailoring therapies to the start of seizure onset,¹ better seizure management and treatment,² and useful information that can be used to modify daily activities.^2,3
 
Empatica develops continuous, unobtrusive remote health monitoring driven by artificial intelligence. 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 latest flagship medical wearable, EmbracePlus, has been developed with key partners including HHS, USAMRDC, and NASA.

References 
¹ Epilepsy Foundation (https://www.epilepsy.com/research-funding/epilepsy-innovation-institute/seizure-gauge-challenge)
² https://www.nature.com/articles/s41598-021-01449-2
³ https://pubmed.ncbi.nlm.nih.gov/33040327/