Empatica Inc’s smart watch for epilepsy management, Embrace, has received 510(k) clearance from the US Food and Drug Administration (FDA) for use in children ages six years and older. This comes exactly a year after Embrace received FDA clearance for seizure monitoring in adults.
The Embrace wearable detects patterns in motion and physiological signals that may be associated with generalised tonic-clonic seizures, and immediately alerts caregivers. According to Empatica, Embrace is the first non-EEG based physiology signal seizure monitoring system to be cleared by the FDA for use in a paediatric population.
This new FDA clearance means parents can use the officially clinically validated technology to monitor their children who have epilepsy. Doctors can also now use the technology to assist in patient treatment and care.
“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 Director at NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery (INN), Dr Orrin Devinsky.
Empatica CEO and Co-founder, Matteo Lai, noted that their team worked hard to expand the use of the Embrace for seizure monitoring. “We realised 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.”
According to the American Epilepsy Society, 25% of all people with epilepsy have generalised tonic-clonic seizures, which are most commonly associated with Sudden Unexpected Death in Epilepsy (SUDEP). The best way to prevent SUDEP is to prevent seizures by taking medications regularly; however, about one-third of people’s seizures are still not controlled by medications. When patients have generalised tonic-clonic seizures, also known as “grand mal” seizures, their risk of SUDEP is lowered if they have somebody present at the time of the seizure.
“We are so happy to provide Embrace with FDA’s formal clearance of its use by paediatric 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,” said Empatica Co-founder, Chief Scientist and MIT Professor, Rosalind Picard.
Clinical testing of Embrace was carried out in an Epilepsy Monitoring Unit (EMU) among 141 patients diagnosed with epilepsy. 80 of them were paediatric patients, aged 6-21 years; and 61 were adults. 53 out of 54 generalised tonic-clonic seizures were detected by Embrace for an accuracy rate of 98% during the clinical testing, with the overall FAR for adults (>21 yo) being 0.67, and the one for paediatrics (<=21 yo) being 1.35.