The Embrace2, a seizure monitoring wearable from Boston and Milan-based Embrace, has received an updated FDA clearance that allows it to be used by children ages six and up — the first such device to receive clearance for pediatric use.
"The fact that this is the first clearance of its kind in epilepsy highlights how difficult it is to get robust results with pediatric patients in a clinical environment," the company wrote in a blog post. "This also demonstrates the commitment and hard work we’ve put in to expand access to our cutting-edge clinical technology. For families, this means that they can monitor their child’s tonic-clonic seizures directly at home, and receive immediate notification when assistance is needed. For physicians, they can enhance the quality of monitoring by offering non-invasive solutions that easily integrate into their patient’s lives and offer them more freedom."
The device, which will be available by prescription only, can monitor the user for tonic-clonic seizures, the seizure type most associated with SUDEP (Sudden Unexpected Death in Epilepsy). It can notify family members and caregivers when a seizure begins so that they can seek out help for the patient.
Embrace, which retails for $249 plus a $9.99 per month subscription fee, also works as a watch and as a fitness tracker, tracking sleep, stress and physical activity.
Why it matters
According to the Epilepsy Foundation, about 300,000 American children under the age of 14 have epilepsy. For these patients, an accessible and innocuous monitoring device can not only potentially save their lives, but it can also give parents some piece of mind.
"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."
What's the trend
When Embrace received its original FDA clearance, for adults, in early 2018, MobiHealthNews noted the long journey the technology went on to get here including development by two different companies, a crowdfunding campaign, and a number of clinical trials. Perhaps this difficulty explains why the space has not been an overly crowded one.
One other company, Smart Monitor, markets a non-FDA-cleared device that's advertised to "detect abnormal motion." A number of other research studies have demonstrated potential of wearables for siezure detection.
Most recently, NightWatch, a connected armband from Leiden, Netherlands-based LivAssured, showed promise in a study of nighttime seizure detection. The company recently launched commercially in Europe.