The Embrace seizure-detecting wearable

Embrace
(Empatica)

More than 3,000 people with epilepsy in the U.S. die unexpectedly each year, but a spinout of the MIT Media Lab has developed a device it hopes can prevent those deaths. And it's a wearable that fits right into a patient's daily wardrobe. 

Empatica's watch-sized device, dubbed Embrace, can automatically summon help from family members and caregivers if it detects a convulsive seizure. It looks similar to other smartwatches and fitness trackers—and shares some of their features—but it contains a gyroscope, accelerometer and thermometer, plus a sensor to measure electrical changes in the skin, all tuned to spot the patterns of generalized tonic-clonic seizures. 

When it senses a seizure, it alerts caregivers with the user’s location via a text message and automated phone call. The risk of death from epilepsy can drop if someone is present during or shortly after a seizure, Empatica said. 

The FDA granted the company its first 510(k) clearance in January 2018, after the device and its algorithm successfully detected every seizure that occurred in a clinical trial of 135 patients in a controlled setting. It issued alerts on different types of seizures, too. But it also set off false alarms—once about every two days in the study, on average.  

RELATED: Empatica eyes delivery of wearable epilepsy device following successful crowdfunding campaign  

Since then, Empatica has released the second version of its prescription device and picked up a second FDA clearance for use in children over age 6, making it the first non-EEG-based monitoring system cleared in pediatrics, the company said. The Embrace2 features a longer battery life and a redesigned watch face. 

The Epilepsy Foundation estimates that about 3.4 million people in the U.S. are living with the condition, including 300,000 children under age 14, with about a quarter suffering tonic-clonic seizures, also known as grand mal seizures. Sudden death from epilepsy is a leading neurological cause of death, second only to stroke, Empatica says. 

The Embrace seizure-detecting wearable

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