MIT Media Lab spin-off, Empatica Inc., has received medical device clearance from the US Food and Drug Association (FDA) for Embrace, its smart watch for Epilepsy Management.

Embrace uses machine learning to identify and monitor convulsive seizures and sends alerts to caregivers. It also provides sleep, rest and physical activity analysis.

“Medical devices face a huge problem: they’re usually too bulky and uncomfortable, and people simply don’t want to wear them. Empatica took a different path. We wanted to design the world’s first medical device that could win a design award, while being used as a lifesaving product,” said Co-founder and CEO of Empatica, Matteo Lai.

Empatica recently underwent a multi-site clinical study where 135 patients diagnosed with epilepsy were admitted to top level IV epilepsy monitoring units for continuous monitoring with video-EEG, while simultaneously wearing an Empatica device.

From these patients, 6,530 hours of data were recorded over 272 days, including 40 generalised tonic-clonic seizures. Embrace’s algorithm was shown to detect 100% of the seizures. The trial used the gold standard of comparing to seizures clinically labelled by at least two out of three independent epileptologists, who examined the video-EEG data without seeing any data used by Embrace.

Generalised tonic-clonic seizures result in a loss of consciousness and can leave the person in a state of confusion for some time afterwards. Traditionally, clinical trials have had to rely upon patients to self-report in a diary when a seizure happens, a process known to be inaccurate.

Embrace’s high sensitivity makes seizure reporting easier and more accurate, and is a feasible alternative to wearing an EEG.

“It’s been quite the journey – we have worked for years building wearable stress and emotion sensors, and then accidentally discovered we could pick up changes in the skin elicited by brain activity related to the most dangerous kinds of seizures,” said Chief Scientist at Empatica, Rosalind Picard.

“It has been very meaningful to see this technology move from the lab into the most accurate, beautiful and easy to use sensor on the market,” concluded Picard.

Embrace had already been approved in Europe as a medical device for seizure monitoring and alert since April 2017. For more information about Embrace, visit: https://www.empatica.com/en-eu/

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