Seizure-monitoring smart watch scores FDA clearance

por Lauren Dubinsky, Senior Reporter | February 14, 2018
Alzheimers/Neurology Health IT Medical Devices
Detects life-threatening
grand mal seizures
Empatica announced last Monday that its Embrace artificial intelligence-based smart watch received FDA clearance to monitor grand mal seizures and alert caregivers that help is needed.

“EEG's can't be used all day, every day like Embrace can, so EEGs miss a lot of important events that Embrace can catch,” Rosalind Picard, director of the Affective Computing Group and chief scientist at Empatica, told HCB News. “Embrace does not aim to replace the EEG. It gives complementary information, not the same information.”

Data from the Centers for Disease Control and Prevention reveal that about 3.5 million people in the U.S. suffer with epilepsy. According to the Epilepsy Foundation, medication does not control seizures for three out of 10 of them.
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Embrace uses advanced machine learning technology to identify the convulsive seizures. It’s different from other seizure detection systems in that it quantifies physiological changes in sympathetic nervous system activity.

It was tested in a multi-site clinical study that involved 135 patients with epilepsy. They were admitted to top level IV epilepsy monitoring units for continuous monitoring with video EEG, and simultaneously wore the Empatica watch.

The researchers collected 6,530 hours of data over the course of 272 days. They found that Embrace was able to detect 100 percent of the 40 seizures that three independent epileptologists identified with the video-EEG data.

According to Picard, her team worked for years on creating wearable stress and emotion sensors and accidentally discovered they could track changes in the skin elicited by brain activity related to the most dangerous types of seizures.

Empatica initially launched Embrace through a crowdfunding campaign in 2015. In April 2017, the device scored CE mark.

“Physicians are very excited,” said Picard. “We have been working closely with physicians on Embrace for years, and many of them helped us get to where we are.”

Patients are also responding positively to the Embrace watch. In November 2016, Morgan McGrath experienced a life-threatening seizure that lasted over 40 minutes and Embrace alerted her emergency contacts.

“I was in the hospital for a total of four days with three of those days being in ICU,” she said in a statement. “I believe the Embrace saved my life. It helps give peace of mind to me, as well as my friends and family.”

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