Empatica's seizure-detecting Embrace wearable just got FDA approval

Empatica's Embrace wearable started life as an MIT Media Lab project, but went on to crowdfunding success and shipped to backers. Now it's tackled another milestone: FDA approval.

The device uses sensors to track electrodermal activity, which is sweat induced moisture that allows the device to detect spikes in activity. Basically, it can tell when you're anxious, depressed or stressed. It can also be used to tell when someone is about to have an epileptic seizure.

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Empatica's AI engine can use the data from the watch to help monitor for two of the more dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures and then send an alert to call for help from emergency caregivers.

The Embrace was used in a multistate clinical study with 135 patients, who provided 1,350 hours of data over 272 days. 40 generalized tonic-clonic seizures were recored, and Empatica's AI was able to detect the seizure 100% of the time. To confirm Empatica's detection, the seizures were clinically labelled by at least two out of three independent epileptologists, who did not see Empatica's data.

Generalized tonic-clonic seizures tend to leave the person in a state of confusion as they typically resolve in a loss of consciousness. Typically, clinical trials have required patients to self-report generalized tonic-clonic seizures, which is ineffective if the person doesn't understand what just happened. This has caused dangerous generalized tonic-clonic seizures to go unreported.

Now that the Embrace has received the FDA stamp of approval, it can be used to help diagnose seizures in medical situations with more confidence. Nearly 65 million people in the world suffer from epilepsy, with one in 29 people in the US getting diagnosed at some point in their lives.