FDA Approves the First Smart Watch for Managing Epilepsy
The US Food and Drug Administration (FDA) has recently approved the smart watch Embrace to monitor for various types of seizures among individuals with epilepsy.
Manufactured by Empatica Inc, the watch is programmed to detect the occurrence of grand mal and generalized tonic-clonic seizures among wearers and can send an alert to caregivers for help.
Embrace was approved following the success of a multi-site clinical study that assessed the utility of the watch among 135 patients diagnosed with epilepsy. Embrace’s algorithm proved highly effective, detecting all 40 generalized tonic-clonic seizures that occurred throughout the trial.
Embrace by Empatica is the world's first smart watch to be cleared by FDA for use in neurology [press release]. Cambridge, MA. PR Newswire. February 5, 2018. https://www.prnewswire.com/news-releases/embrace-by-empatica-is-the-worlds-first-smart-watch-to-be-cleared-by-fda-for-use-in-neurology-300593398.html. Accessed on February 7, 2018.