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Embrace had an accuracy rate of 98 percent during clinical testing.
The thumbnail and image above have been cropped and resized. Courtesy of (PRNewsfoto/Empatica Inc.).
Embrace, an epilepsy smartband that uses artificial intelligence to detect patterns and signals associated with seizures, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use in children, according to an announcement.
The smartband, made by Empatica, detects motion patterns and physiological signals that are associated with generalized tonic-clonic seizures and immediately alerts caregivers.
Empatica conducted clinical testing on the product in an epilepsy monitoring unit among 141 patients diagnosed with epilepsy. The testing was carried out on 80 pediatric patients, aged 6 to 21 years, and 61 adults. Embrace detected 53 out of 54 generalized tonic-clonic seizures for an accuracy rate of 98 percent.
A total of 3.4 million people in the U.S. have epilepsy, including 300,000 under the age of 14. And 25 percent of people with epilepsy have generalized tonic-clonic seizures that are associated with Sudden Unexpected Death in Epilepsy (SUDEP), the second leading neurological cause of total years of potential life lost in the U.S.
Annually, an estimated 101,000 years of life are being lost due to SUDEP, second only to stroke.
Preventing SUDEP can be done by taking medication regularly to prevent seizures, but about one-third of patient’s seizures are not controlled by medication.
Immediate assistance is critical for patients that experience epilepsy. Patients with tonic-clonic seizures lower their risk of SUDEP if they have someone present at the time of the seizure.
So what does this mean for parents and doctors?
Now that the FDA has cleared the product for children, parents now have access to clinically validated technology and doctors have reliable technology to assist in 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 Orrin Devinsky, M.D., director at NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery.
Last January, Embrace received FDA clearance for monitoring seizures in adults.
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