The FDA has expanded approval for the Embrace smartband to be used by children aged 6 years and older with epilepsy.
The US Food and Drug Administration (FDA) has granted 510(k) clearance to the Embrace smartband for use in children ages 6 years and older with epilepsy. The smartband detects patterns in motion as well as physiological signs that may indicate generalized tonic-clonic seizures and 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, Director at NYU Comprehensive Epilepsy Center and the Saint Barnabas Institute of Neurology and Neurosurgery (INN).
A clinical trial of 141 patients with epilepsy, including 80 pediatric patients aged 6-21 years, supported the 510(k) clearance for the pediatric use of Embrace. The Embrace smartband detected with 98% accuracy, identifying 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 co-founder, chief scientist, and professor at MIT.
Embrace was approved for use in adults with epilepsy in early 2018, supported by results of a clinical trial of 135 patients. Participants were monitored via video electroencephalography (EEG) as well as the Embrace smartband. The Embrace device detected 40 generalized tonic-clonic seizures with 100% accuracy.
"We are very grateful for this result," said Matteo Lai, Empatica 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."