FDA Approves First Smart Watch in Neurology

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Empatica In has received FDA approval for smart watch named as Embrace, which is designed for people suffering from Epilepsy

Embrace uses Artificial Intelligence to monitor severe form of seizures, which is known as grand mal or generalized tonic-clonic seizures. Upon detection of an activity, Embrace sends out signals via the patient’s smartphone to caregivers and notify them regarding situation. Embrace is already approved in Europe as a medical device for seizure monitoring and alert from April 2017. The smart watch was observe to detect seizures with 100% accuracy.

According to recent data published by CDC, around 1.2% of the U.S. population suffers from Epilepsy. Around 35% of these patients do not respond to medication to control their seizures, while another third is only partially responsive to medication. As a part of study to test this smart watch, 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. Out of those patients, around 6,530 hours of data were recorded over 272 days, including 40 generalized tonic-clonic 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.

Seizures are characterized by loss of consciousness, which leaves the person in a state of confusion for some time. Embrace’s high sensitivity makes accurate and easy detection of seizures. It is different as compared to any seizure detection system in terms of measuring multiple indicators of a seizure. The unique feature of this smart watch is that it uses Electrodermal Activity (EDA), a signal used by stress researchers to quantify physiological changes related to sympathetic nervous system activity, which is also known as ‘fight or flight’ response.


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