FDA Approves Seizure-Detecting Smartband Embrace 2 for Use by Children

Embrace 2 Seizure Detection
Image: Empatica

The US Food and Drug Administration (FDA) has approved Embrace 2, a seizure monitoring smart wristband to be used by children ages 6 and up. Developed by Boston and Milan-based Empatica, this is the first such device to receive clearance for pediatric use, reports MobiHealthNews.

“We’re proud to announce that Embrace2 has received FDA clearance for children ages 6 and up, the company wrote in a blog post. “This significant accomplishment makes it the first wrist-worn wearable in the field of epilepsy to be cleared as a medical device for children. It is yet another milestone that reinforces our commitment to improving the lives of the millions of families living with epilepsy.”

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The Epilepsy Foundation estimates there are around 300,000 American children under the age of 14 have epilepsy. A device like this not only save lives but also give parents some piece of mind.

Mobile app
Image: Empatica

Embrace 2 uses advanced machine learning to detect unusual patterns that may be associated with convulsive seizures, and immediately notifies caregivers. It also provides rest and physical activity analysis to better understand your lifestyle. And with fast charging and a 48+ hour battery life, it gives you more freedom to do more of what you love.

“We are so happy to provide Embrace with FDA’s formal clearance of its use by pediatric subjects aged six to 21,” Empatica Chief Scientist and MIT Professor Rosalind Picard said in a statement. “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.”

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Embrace 2 retails for $249 plus a $9.99 per month subscription fee. The device also works as a smartwatch that tracks stress, sleep and physical activity.

Embrace 2 is a prescription-only medical device indicated for use as an adjunct to seizure monitoring in home or healthcare facilities during periods of rest, according to the company.