The FDA cleared Embrace, a smartwatch capable of monitoring seizures, according to a Feb. 5 statement by the product's developer Empatica.
Embrace, which has been approved as a medical device for seizure monitoring and alert in Europe since April 2017, uses artificial intelligence to monitor various indicators of seizure onset, such as physiological changes related to sympathetic nervous system activity.
The smartwatch aims to detect one of the most dangerous types of seizures, known as "grand mal" or "generalized tonic-clonic" seizures. Once detected, the smartwatch delivers an alert to a pre-selected caregiver.
In a multisite clinical study of 135 epilepsy patients, Embrace detected 100 percent of the 40 generalized tonic-clonic seizures patients experienced during the course of 272 days.
"Medical devices face a huge problem: they're usually too bulky and uncomfortable, and people simply don't want to wear them," said Matteo Lai, co-founder and CEO of Empatica. "We wanted to design the world's first medical device that could win a design award, while being used as a lifesaving product."