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Smart wearable Embrace is now an FDA-approved medical device for epilepsy patients
- The Embrace wearable is an app-linked device that monitors seizures.
- On sale for years, the device finally achieved FDA-approval as a medical device.
- This is the first time a smartwatch has been approved within the field of Neurology.
In 2014, medical company Empatica ran a crowdfunding campaign to raise seed money for a smart wearable called Embrace — a smartwatch-like device that scans for signs of a seizure in people with epilepsy. The campaign netted Empatica $100,000 in less than 24 hours, and eventually reached nearly $800,000 by the end.
Embrace went on sale shortly after the campaign concluded and has been helping epilepsy patients stay safe ever since. Late January became a milestone for Empatica, as the U.S. Food and Drug Administration finally cleared embrace as an approved medical device. This is the first time the FDA approved a smartwatch in the field of Neurology.
Patients wear Embrace around their wrists 24 hours a day. The wearable is linked to a smartphone app (available for Android and iOS) that sends out an alert should the person wearing Embrace go into a seizure. This enables parents and loved ones always to keep tabs on those in their lives who suffer from epilepsy.
There’s also another linked app that keeps a log of any seizure activity the wearer experiences, creating what Empatica calls a Seizure Diary. This helps people determine what might be triggering seizures as well as take note of smaller seizures that happen during sleep.
The technology behind Embrace developed at MIT in 2007 and then went through years-long testing phases at various hospitals. The document Empatica eventually submitted to the FDA was over 1,500 pages long and was filed in mid-2016, so this approval has been a long time coming. Now that Embrace is officially a medical device, it will be easier for lower-income patients to purchase one through insurance providers.
This is a perfect example of technology helping to better everyone’s lives. If you or someone you know suffers from epileptic seizures, check out the Empatica website to see if Embrace might help.