The Embrace2, a seizure monitoring wearable from Boston and Milan-based Embrace, has received an updated FDA clearance that allows it to be used by children ages six and up — the first such device to receive clearance for pediatric use.
"The fact that this is the first clearance of its kind in epilepsy highlights how difficult it is to get robust results with pediatric patients in a clinical...
Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA last month. The wearable, which has already been used in clinical trials by pharma company Sunovion, has a long history that's led it up to this milestone.
The clearance is as a prescription, not an over-the-counter device, which means users will have to secure a prescription...
Marlborough, Massachusetts-based pharma company Sunovion will use the Empatica Embrace, a wearable device for seizure detection, in a phase 4 clinical study of Aptiom, a drug meant to reduce seizures in people with epilepsy.
“We believe that incorporating digital health technologies into traditional treatment paradigms has the potential to inform and enhance best practices and further empower...
One of the great but nebulous promises of wearable health trackers is that, by monitoring something 24-7 that previously was only ever monitored intermittently, it will help us discover new things about our bodies and health. MIT Professor and Empatica Chief Scientist Rosalind Picard can do one better -- a wearable device she designed helped her to make an accidental discovery that could change...
Cambridge, Massachusetts and Milan, Italy-based Empatica is crowdfunding a new wristworn tracker device, Embrace, which brings clinically validated tracking methods to the consumer market. The technology has an initial primary focus on epilepsy, but is also usable for activity, stress and sleep tracking in healthy individuals and will gradually add use cases for other chronic conditions including...
