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Medical Devices / Submissions and Approvals

Empatica’s Epilepsy Band Cleared for Pediatric Use

Jan. 10, 2019
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The FDA granted 510(k) clearance for Empatica’s Embrace epilepsy smartband, allowing it to be used for epilepsy patients aged six and older.

The smartband can sense motion patterns and physiological signs that may indicate generalized seizures and alert caregivers to them.

In a clinical trial of 141 patients with epilepsy, which included 80 pediatric patients aged six to 21 years, the device had a 98 percent accuracy rate, identifying 53 out of 54 generalized tonic-clonic seizures.

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