FDA Clears First-in-Class NonEEG, Seizure-Monitoring, Wearable Device for Children

Tuesday, January 08, 2019

The Food and Drug Administration (FDA) has granted 510(k) clearance for a wearable smartband device (Embrace; Empatica, Boston, MA) to detect seizure activity in children age 6 years and up. This smartband device detects presence and intensity of movement and electrodermal signals that indicate sweat gland activity (an indirect measure of sympathetic nerve activity) and immediately alerts caregivers when signals that indicate seizure activity occur. This device can also pair with an application that helps patients and caregivers keep an accurate seizure diary. 

In clinical testing of 80 children (age 6-21) in an epilepsy monitoring unit, the device had a 98% accuracy rate, detecting 53 of 54 tonic-clonic seizures that occurred. This seizure monitoring device was approved for use in adults in January 2018 and has a 94% accuracy rate for seizure detection in adults.

Giving caregivers clinically tested, accurate alerting of seizure activity is likely to improve quality of sleep and thus quality of life. As a correlation between unmonitored sleep and sudden unexplained death in epilepsy (SUDEP) has been reported, use of seizure detection devices may have the potential to reduce SUDEP, particularly in the 30% to 40% of patients with epilepsy who are refractory to treatment.  

Empatica co-founder, chief scientist, and MIT professor Rosalind Picard, has stated: "We are so happy to provide Embrace with FDA's formal clearance of its use by pediatric subjects aged 6-21. Embrace improves the likelihood that a trusted caregiver will be there during the critical moments after a seizure happens. Having somebody present is associated with better health outcomes."

"The clearance of the Embrace watch to detect seizures in children ages 6 years and older is an important step forward in our ability to identify seizures rapidly and thereby allow parents or others to respond," said Dr. Orrin Devinsky, Director at NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery (INN).

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