Empatica Launch Next-Gen FDA-Cleared Epilepsy Watch

Empatica, a company focused on continuous, unobtrusive remote health monitoring driven by artificial intelligence (AI), recently announced the launch of its EpiMonitor watch, which is FDA cleared for use in adults and children aged six and up for seizure detection.

EpiMonitor is, according to Empatica, the only wearable solution with regulatory clearance for seizure detection available for purchase in the United States and is a successor to Embrace2, which became the first available to patients. Utilizing the company’s medical watch EmbracePlus, a companion smartphone app, and smart algorithms, EpiMonitor continuously monitors a wearers health data, detecting possible generalized tonic-clonic seizures, alerting caregivers, and providing valuable health information to help better manage the condition.

Key features of EpiMonitor include automatic seizure detection through a smart algorithm that has a 98% accuracy rate and a low false alarm rate, ability to alert caregivers via call or text message with a user’s location, up to seven days of battery life, advanced sensor technology for accurate data collection, an option to send self-triggered alerts to caregivers, an easy to use mobile app with a seizure diary, sleep and activity tracking abilities through the device’s algorithms, and seizure, sleep, and activity reports that can be exported and shared with a physician. The companion app is compatible with both iOS and Android.

"We are thrilled to introduce EpiMonitor to people with epilepsy in the US,” said Dr. Rosalind Picard, Empatica’s chief scientist and co-founder, in the press release announcing the launch. “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.”

In tandem with the EpiMonitor news, Empatica also announced the launch of its Foresight clinical study to develop a seizure forecasting algorithm based on “the world’s largest real-world data set in epilepsy patients,” according to the company.

Seizure forecasting could have multiple benefits, Empatica said, including early intervention in the form of tailoring therapies to the start of seizure onsite, better seizure management and treatment, and information that can be used to modify daily activities.

Recruitment for the study is available to all US-based EpiMonitor users.