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Embrace by Empatica is the world's first smart watch to be cleared by FDA for use in Neurology

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CAMBRIDGE, Mass., Feb. 5, 2018 /PRNewswire/ — Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch.  Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as “grand mal” or “generalized tonic-clonic” seizures, and send an alert to summon caregivers’ help.

Embrace is a smart watch for Epilepsy Management which uses advanced machine learning to identify convulsive seizures and send alerts to caregivers. It also provides sleep, rest, and physical activity analysis.

In a 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 an Empatica device.   From these patients, 6,530 hours of data were recorded over 272 days, including 40 generalized tonic-clonic seizures. Embrace’s algorithm was shown to detect 100% of the seizures. The trial used the gold standard of comparing to seizures clinically labelled by at least 2 out of 3 independent epileptologists, who examined the video-EEG data without seeing any data used by Embrace.

Embrace stands apart from any seizure detection system in that it measures multiple indicators of a seizure. Its unique property is its use of Electrodermal Activity (EDA), a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, also known as the “fight or flight” response.   Embrace had already been approved in Europe as a medical device for seizure monitoring and alert since April 2017.

According to recent estimates by CDC1, 1.2% of the US population suffers from Epilepsy, amounting to around 3.4 million patients, including 470,000 children. Around 35% of these patients do not respond to medication to control their seizures, while another third is only partially responsive to medication2.

Generalized tonic-clonic seizures result in a loss of consciousness and can leave the person in a state of confusion for some time afterwards. Traditionally, clinical trials have had to rely upon patients to self-report in a diary when a seizure happens, a process known to be inaccurate. Over 40% of the most dangerous generalized tonic-clonic seizures are not reported3, but Embrace’s high sensitivity makes seizure reporting easier and more accurate. The bracelet also sends an alert immediately to a caregiver, to bring help at the time of need.

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