FDA clears Empatica’s smartwatch for seizure monitoring - Verdict Medical Devices
Join Our Newsletter - Get important industry news and analysis sent to your inbox – sign up to our e-Newsletter here
X

FDA clears Empatica’s smartwatch for seizure monitoring

06 Feb 2018 (Last Updated August 28th, 2018 16:06)

Empatica, a Massachusetts Institute of Technology (MIT) Media Lab spin-off, has obtained the US Food and Drug Administration (FDA) clearance for its smartwatch called Embrace designed to monitor seizures.

FDA clears Empatica’s smartwatch for seizure monitoring
Embrace is a smartwatch for epilepsy management. Credit: PRNewsfoto / Empatica.

Empatica, a Massachusetts Institute of Technology (MIT) Media Lab spin-off, has obtained the US Food and Drug Administration (FDA) clearance for its smartwatch called Embrace designed to monitor seizures.

Powered by artificial intelligence (AI), the wearable device uses advanced machine learning to check for the grand mal or generalised tonic-clonic seizures and sends instant alerts for caregiver help.

The smartwatch leverages electrodermal activity (EDA) to measure several seizure indicators and quantify physiological changes associated with the activity of the sympathetic nervous system.

It can also be used for the continuous capture of data related to sleep, stress, and physical activity.

Empatica chief scientist Rosalind Picard said: “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.”

“Embrace’s algorithm detected all of the 40 generalised tonic-clonic seizures that occurred during the study period.”

The firm validated Embrace in a multi-site clinical study involving 135 subjects suffering from epilepsy. These patients were admitted to level IV epilepsy monitoring units where they were subjected to simultaneous, continuous monitoring with video-EEG and an Empatica device.

Analysis of 6,530 hours of data recorded over 272 days showed that Embrace’s algorithm detected all of the 40 generalised tonic-clonic seizures that occurred during the study period.

Results obtained with Embrace were compared to those clinical labelled by two out of three independent epileptologists who analysed only the video-EEG data.

Embrace also obtained approval as a medical device for monitoring seizures and sending alerts in Europe in April last year.