Seizure-alerting Device Recently Approved by FDA Received Early Support from the Epilepsy Foundation
Epilepsy News From: Wednesday, January 16, 2019
In December 2018, the U.S. Food and Drug Administration (FDA) granted clearance to market the Embrace smartband for seizure-monitoring use in children. Embrace is the first non-EEG (non-electroencephalogram) based physiology signal seizure monitoring system to be cleared by the FDA for use in children 6 years old and older.
- Generalized tonic-clonic seizures are more likely to be detected than other seizure types.
- There is relatively little data on use of this smartband on children.
- These devices are not foolproof. There are both false positives and false negatives.
Originally Published February 6, 2018
Empatica Inc. received clearance from the FDA on February 5, 2018, for Embrace, a seizure-alerting smart watch that identifies generalized tonic-clonic seizures and sends alerts to caregivers. It also tracks activity, stress, and overall balance.
Clearance indicates the device is considered safe, effective, and “substantially equivalent” to other products reviewed by the agency. To obtain clearance, Empatica conducted a multi-site clinical study that included 135 people living with epilepsy who wore the device while undergoing video EEG monitoring. The device successfully detected all tonic-clonic seizures that were independently identified by epileptologists who looked at the video EEG data.
“It is so exciting to see new products for persons with epilepsy that help to return some independence for their lives,” said epilepsy.com Editor-in-Chief Joseph I. Sirven.
The Epilepsy Foundation is dedicated to helping people living with epilepsy live to their fullest potential. Innovative devices like the Embrace watch are signs of progress that are making a difference in lives right now.
Early Investment in Innovative Technology
Empatica Inc. received early funding support from the Epilepsy Foundation. After winning the People’s Choice Award during the 2013 Shark Tank Competition, Empatica Inc. partnered with the Epilepsy Foundation on a crowdfunding Indiegogo campaign. The campaign raised epilepsy awareness and funding for further development of the device. It also included a buy one, give one component. As a result, the Epilepsy Foundation was able to give more than 1,500 Embrace watches to families in need. (This campaign is now closed.)
Empatica Inc. also received $75,000 as the winner of the Judges Choice Award at the 2015 Shark Tank Competition. They won for their project, “Embrace: Learn How Stress and Sleep Impact Your Seizures.”
Embrace watches are currently available for purchase. There is an additional cost per month for the monitoring app that pairs with the watch. Empatica Inc. offers advice on pursuing insurance reimbursement for Embrace.
Elaine Wirrell MD
Wednesday, January 16, 2019