Empatica Reveals Next Generation FDA-Cleared Epilepsy Watch and Launches AI Seizure Forecasting Study

Empatica Reveals Next Generation FDA-Cleared Epilepsy Watch and Launches AI Seizure Forecasting Study

Empatica Reveals Next Generation FDA-Cleared Epilepsy Watch and Launches AI Seizure Forecasting Study

EpiMonitor is an all-in-one epilepsy monitoring solution that uses the EmbracePlus wearable and a mobile app to detect and alert for seizures, while providing patients and physicians with continuous, accurate health insights

BOSTON–(BUSINESS WIRE)–Empatica, a leader in remote health monitoring powered by AI, is proud to announce 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 US. It is the successor to Embrace2, which enjoyed global acclaim as the leading wearable for seizure detection for years, and the first ever to be available to patients.

EpiMonitor represents a significant 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.

We are thrilled to introduce EpiMonitor to people with epilepsy in the US,” said Empatica’s Chief Scientist and Co-founder, Dr. Rosalind Picard. “Empatica has always provided the only smartwatch seizure monitors validated by the FDA. EpiMonitor takes this to a new level: giving patients up to 7 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. EpiMonitor is the device we’ve long dreamed of to open a new era in giving epilepsy patients greater control over their lives.”

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.

Seizure forecasting

In December 2023, Empatica also announced plans to conduct a groundbreaking 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 US-based EpiMonitor users.

Our FORESIGHT clinical study is an incredibly exciting opportunity to advance personalized seizure forecasting,” said Dr. Marisa Cruz, Empatica’s Chief Medical Officer. “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.”

By enrolling in the study, users can contribute valuable data to ongoing research efforts, and participate in a large-scale scientific effort to create a better tomorrow for people living with epilepsy. Large datasets are extremely important to train an algorithm to achieve a prediction of when someone will have a seizure, but they are also extremely difficult to gather. With this study, Empatica seeks to overcome this challenge with the participation of its community.

Seizure forecasting can have multiple benefits, including early intervention in the form of tailoring therapies to the start of seizure onset1, better seizure management and treatment2, and useful information that can be used to modify daily activities2,3.

EpiMonitor is available for purchase in the US from the Empatica website. To learn more visit empatica.com/epimonitor.

Empatica Inc is a pioneer in continuous, unobtrusive remote health monitoring driven by AI. 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.

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/


Marianna Xenophontos