Empatica is a Cambridge, MA-based company that designs, produces, and develops AI-enabled wearables, software, and digital markers. These wearables are used in health monitoring, treatment, and research. Obstacles to utilizing wearable technologies include privacy compliance and HIPAA data standards.
Embrace2 is an FDA-cleared medical device that is worn on the wrist and can detect patterns that may be associated with a generalized tonic-clonic seizure and immediately alert caregivers and a physician with information about the patient. FDA clearance allows it to be used by children ages six and up; it is first epilepsy monitoring device to receive clearance for pediatric use.The device works through four sensors: electrodermal activity, temperature, accelerometer, and gyroscope. The device is available by prescription only.
Marlborough, Massachusetts-based pharma company Sunovion used the Empatica Embrace2 in a 2016 phase 4 clinical study of Aptiom, a drug meant to reduce seizures in people with epilepsy.