Smart wearable Embrace is now an FDA-approved medical device for epilepsy patients

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Empatica

• 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.

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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.

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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.

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