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Previously approved for use in adults with epilepsy in 2018, the band uses pattern detection to pick up on movement and physiological signatures indicating the occurrence of generalized tonic-clonic seizures.
Orrin Devinsky, MD
The FDA has given 510(k) device clearance to Empatica for its Embrace smartband for use in pediatric patients with epilepsy aged 6 years and older.1
The smartband, previously approved for use in adults with epilepsy in February 2018, uses pattern detection to pick up on movement and physiological signatures indicating the occurrence of generalized tonic-clonic seizures. When it picks up the signature, it alerts caregivers with the information.
"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 Orrin Devinsky, MD, the director of the NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery, in a statement.
Previously, Devinsky pointed to the smartband’s ability to alarm family members and caretakers that a tonic-clonic seizure is occurring, which could offer help in preventing the more than 3000 deaths from Sudden Unexpected Death in Epilepsy (SUDEP) each year. “The scientific evidence strongly supports that prompt attention during or shortly after these convulsive seizures can be life-saving in many cases," he said at the time.2
In a clinical trial of 141 patients with epilepsy within an Epilepsy Monitoring Unit, including 80 pediatric patients aged 6 to 21 years, the smartband detected seizures with 98% accuracy. Ultimately, it identified 53 out of 54 generalized tonic-clonic seizures.
"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," said Rosalind Picard, ScD, Empatica’s co-founder, chief scientist, and professor at the Massachusetts Institute of Technology.
Its 2018 approval was supported by results ofa multicenter clinical trial of 135 patients with epilepsy that had been admitted for continuous monitoring via video electroencephalography (EEG) over the course of 272 days. The patients were also given the Embrace smartwatch to wear simultaneously. The trial recorded more than 6500 hours of data, including 40 generalized tonic-clonic seizures—which the Embrace smartwatch detected with 100% accuracy. In order to determine the efficacy, the seizures needed to clinically be affirmed and agreed upon by at least 2 of 3 independent epileptologists, who made their assessments without access to the Embrace data.
"We are very grateful for this result," said Matteo Lai, BSc, MSc, Empatica’s CEO and co-founder. "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."
1. Embrace by Empatica Receives First of Its Kind FDA Clearance in Epilepsy for Children [press release]. Boston, MA: Empatica; Published January 8, 2019. prnewswire.com/news-releases/embrace-by-empatica-receives-first-of-its-kind-fda-clearance-in-epilepsy-for-children-819639106.html. Accessed January 8, 2019
2. Embrace by Empatica is the world's first smart watch to be cleared by FDA for use in Neurology [press release]. Cambridge, MA: Empatica; Published February 5, 2018. prnewswire.com/news-releases/embrace-by-empatica-is-the-worlds-first-smart-watch-to-be-cleared-by-fda-for-use-in-neurology-300593398.html. Accessed January 8, 2019.