FDA Clears Smart Watch for Epilepsy Management

The Food and Drug Administration (FDA) has cleared the Embrace (Empatia Inc.) smart watch for epilepsy management. The watch works by using an electrodermal activity (EDA) sensor which measures sympathetic nervous system activity. It continuously collects physiological data, and using advanced machine learning, learns to identify convulsive seizures. When a seizure occurs, the watch sends an alert to caregivers.

In a clinical study, 135 patients diagnosed with epilepsy were admitted to IV epilepsy monitoring units for continuous monitoring with video-EEG, while also wearing Embrace. From these patients, 6,530 hours of data were recorded, including 40 generalized tonic-clonic seizures. Embrace’s algorithm was shown to detect 100% of the seizures. 

Studies have shown that up to 40% of generalized tonic-clonic seizures go unreported (Burneo, G. 2008). The Company, an MIT Media Lab spin-off, hopes the watch can provide an accurate biomarker which can be used outside the hospital to improve seizure reporting. Many trials currently rely on patient-kept diaries.

“The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases,” said Orrin Devinsky, Director of the Comprehensive Epilepsy Center at NYU.

For more information visit Empatica.com.