CAMBRIDGE, Mass. – Empatica Inc. has received clearance from the U.S. Food and Drug Administration for Embrace, an artificial intelligence-powered smart watch that monitors for grand mal seizures in patients with epilepsy. “The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients,” said Orrin Devinsky, director of the Comprehensive Epilepsy Center at New York University, in a statement. “The scientific evidence strongly supports that prompt attention during or shortly after convulsive seizures can be life-saving in many cases.” In a recent multi-site clinical study, 135 patients diagnosed with epilepsy were admitted to top level IV epilepsy monitoring units for continuous monitoring with video-EEG, while simultaneously wearing the device and its algorithm was shown to detect 100% of the seizures. Embrace measures multiple indicators of a seizure using of electrodermal activity, a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, also known as the “fight or flight” response. Empatica Inc. is a Massachusetts Institute of Technology Media Lab spin-off, with offices in Cambridge, Mass. and Milan, Italy.
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