Embrace2 Receives FDA Clearance for Children ages 6 and up
Empatica
Jan 10, 2019• 3 min read
We’re proud to announce that Embrace2 has received FDA clearance for children ages 6 and up.
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.
Your children now have access to medical grade technology at home
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. 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.
This milestone was achieved by clinical testing that was carried out in an Epilepsy Monitoring Unit (EMU) among 141 patients diagnosed with epilepsy. 80 of them were pediatric patients, aged 6–21 years; and 61 were adults. 53 out of 54 generalized tonic-clonic seizures were detected by Embrace for an accuracy rate of 98% during the clinical testing, with the overall FAR for adults (>21 y/o) being 0.67, and the one for pediatrics (<=21 y/o) being 1.35. The overall FAR across adults and pediatrics was 0.94.
Dedicated to helping people with epilepsy to live happier lives
In January 2018, Embrace2 received its first FDA clearance for seizure monitoring in adults, making it the world’s first wrist-worn wearable to be cleared by the FDA for use in epilepsy. In Europe, Embrace has been CE certified as a medical device for seizure detection since April 2017.
Beyond this recognition, Embrace has also recently been listed as one of the 18 products that made the world a better place in 2018 by Wired Magazine UK.
We look forward to continuing advancements to provide accessible and effective solutions for people with epilepsy to live happier and healthier lives.
Learn more about how Embrace has been helping give families peace of mind by offering a reliable method to detect possible convulsive seizures.
Embrace is a prescription-only medical device indicated for use as an adjunct to seizure monitoring in home or healthcare facilities during periods of rest. The device detects patterns that may be associated with generalized tonic-clonic seizures in patients with epilepsy or at risk of having epilepsy.
A big hug,
The Empatica Team
Words worth reading
We do not guarantee that EpiMonitor will detect every single seizure and deliver alerts accordingly. It is not meant to substitute your current seizure monitoring practices, but rather to serve as a supplement in expediting first-response time.