FDA Clears Epilepsy Smartwatch for Use in Kids

Jan. 15, 2019 — The FDA has cleared for marketing the Embrace smartwatch for seizure following in children as youthful as age 6.

The Grasp, made by Empatica Inc., recognizes patterns in movement and signals from the body that will be related with generalized tonic-clonic seizures and alarms caregivers right away.

It was approved by the FDA for use in adults in February 2018, as reported by Medscape Restorative News.

“The clearance of the Grasp watch to identify seizures in children ages 6 a long time and more seasoned is an imperative step forward in our ability to recognize seizures quickly and thereby allow parents or others to reply,” Orrin Devinsky, MD, executive of the NYU Comprehensive Epilepsy Center and the Holy person Barnabas Founded of Neurology and Neurosurgery, said in a news discharge from the company.

More than 3 million individuals in the US have epilepsy, including around 300,000 children more youthful than 14. Approximately a quarter of all people with epilepsy have generalized tonic-clonic seizures, which are most regularly related with sudden unforeseen passing in epilepsy.

Grasp was tested in an epilepsy monitoring unit among 141 epilepsy patients, including 80 pediatric patients ages 6 to 21. Generally, 53 of 54 generalized tonic-clonic seizures were detected by Grasp for an exactness rate of 98% amid the clinical testing.


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