Empatica is a Cambridge, MA-based company that produces a wearable device that can detect patterns that may be associated with a generalized tonic-clonic seizure, and immediately alert caregivers.
As of August 2019, Embrace is available only in English. Embrace2 is an FDA-cleared medical device in the USA and a medical device in the EU.
The wearable works by monitoring the Autonomic Nervous System. Sympathetic activation increases when a person experiences excitement or stress whether physical, emotional, or cognitive. The skin is the only organ that is purely innervated by the sympathetic nervous system.
Virtual assistants and wearable technologies are starting to catch the pharma world's attention. The industry is exploring how the new tools can be used in research, clinical trials and inpatient settings. However, obstacles including privacy compliance and data standards are still questions that the industry is grappling with, according to panelists at the MassBio forum on Using Clinical Data...
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.
Empatica's Embrace, the consumer-facing wearable for epileptic seizure detection, received 510(k) clearance from the FDA. The wearable, which has already been used in clinical trials by pharma company Sunovion. 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.
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