Embrace watch1/3/2023 ![]() ![]() ![]() Tragically, more than 3000 Americans die each year from Sudden Unexpected Death in Epilepsy (SUDEP) and the Embrace offers the potential to alarm family members and caretakers that a tonic-clonic seizure is occurring. ![]() "The FDA approval of the Embrace device to detect major convulsive seizures represents a major milestone in the care of epilepsy patients. Orrin Devinsky, one of the world's foremost experts in Epilepsy, Director of the Comprehensive Epilepsy Center at NYU, has seen the shortcomings of traditional systems during his 35+ career. The field has been waiting for decades for a biomarker alternative to wearing an EEG, that can be automated, used outside of the hospital, and isn't bulky or cumbersome to wear. The bracelet also sends an alert immediately to a caregiver, to bring help at the time of need. Over 40% of the most dangerous generalized tonic-clonic seizures are not reported 3, but Embrace's high sensitivity makes seizure reporting easier and more accurate. 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. Generalized tonic-clonic seizures result in a loss of consciousness and can leave the person in a state of confusion for some time afterwards. Around 35% of these patients do not respond to medication to control their seizures, while another third is only partially responsive to medication 2. Embrace had already been approved in Europe as a medical device for seizure monitoring and alert since April 2017.Īccording to recent estimates by CDC 1, 1.2% of the US population suffers from Epilepsy, amounting to around 3.4 million patients, including 470,000 children. 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 stands apart from any seizure detection system in that it measures multiple indicators of a seizure. ![]()
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