Empatica’s pediatric seizure-predicting smartband wins FDA nod

Empatica said that its Embrace epilepsy smartband has received 510(k) clearance from FDA for use in children, a year after winning clearance for adults with epilepsy.
Embrace was designed to detect motion patterns and physiological signals that may be associated with generalized tonic-clonic (“grand mal”) seizures and immediately alert caregivers. It is the first non-EEG based, physiology-signal seizure monitoring system that FDA has cleared for use in a pediatric population, according to the Cambridge, Mass. company.
Clinical testing of Embrace on 141 patients diagnosed with epilepsy, including 80 pediatric patients, yielded a 98% accuracy rate for detecting generalized tonic-clonic seizures, the company said.
About 25% of all people with epilepsy have generalized tonic-clonic seizures, according to the American Epilepsy Society. These seizures are most commonly associated with Sudden Unexpected Death in Epilepsy (SUDEP), the leading cause of death associated with epilepsy.
“The clearance of the Embrace watch to detect seizures in children ages six years and older is an important step forward in our ability to identify seizures rapidly and thereby allow parents or others to respond,” said Orrin Devinsky, M.D., director at New York University’s Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery, in a prepared statement.
“We are very grateful for this result,” said Matteo Lai, Empatica co-founder and CEO. “Empatica’s team worked very hard to expand the use of the Embrace for seizure monitoring, as we realized how much this would mean for the community and parents. We are continuously committed to implement the best science and technology, in order to provide better care to millions of patients living with epilepsy.”
Embrace received the CE Mark as a medical device for seizure detection in 2017.

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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