The US Food and Drug Administration (FDA) has approved Empatica's Embrace smart watch for use in neurology.
By using advanced machine learning (AI) technology, the smart watch will monitor life-threatening seizures called grand mal or generalized tonic-clonic seizures and send an alert to caregivers to help patients.
The watch takes the support of electrodermal activity (EDA), which is a signal used by stress researchers to measure physiological changes linked to sympathetic nervous system activity.
In a multi-site clinical trial, 135 patients diagnosed with epilepsy have been admitted to top level IV epilepsy monitoring units to continuously monitor with video-EEG, while simultaneously wearing an Empatica device.
The trial has collected 6,530 hours of data recorded in over 272 days from the patients. According to the company, Embrace's algorithm was demonstrated to detect 100% of the seizures.
In Europe, Embrace already secured approval as a medical device for seizure monitoring and alert.
Embrace can also continuously capture physiological data of interest for general wellbeing, monitoring sleep and stress, as well as physical activity.
Empatica co-founder and CEO Matteo Lai said: "Medical devices face a huge problem: they're usually too bulky and uncomfortable, and people simply don't want to wear them.
“Empatica took a different path. We wanted to design the world's first medical device that could win a design award, while being used as a lifesaving product. Patients actually love Embrace and are proud to wear it.”
Empatica, which is a MIT Media Lab spin-off, has offices in Cambridge, Massachusetts, and Milan, Italy.
The company also produces E4 research device, which was used to study stress, sleep, migraines, depression and other conditions.
Image: Embrace is a smart watch for epilepsy management. Photo: courtesy of PRNewsFoto / Empatica.