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.
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.