SPEAC System

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Updated: 03/11/2022

Device Description

The SPEAC surface electromyography (sEMG) monitor is worn on one arm at the belly of the biceps muscle. This lightweight, non-invasive monitor continuously senses and monitors sEMG signals which reflect the activity in the motor cortices of the brain. The sEMG monitor takes 1,000 sEMG samples every second. Brain Sentinel’s SparkSenseTM diagnostic algorithm analyzes those samples in real time, looking for tonic-clonic muscle activity that is indicative of a GTC seizure. Once recorded, the data are sent to and stored securely by Brain Sentinel where we begin analyzing all the hours of data. At the end of a monitoring period, the ordering physician will receive a summary report to help with clinical decisions.

Company or Institution

Brain Sentinel

Team Description

Mike Girouard, our President and CEO, and Dr. José E. Cavazos, M.D., PhD, a renowned Epileptologist, founded Brain Sentinel in 2009. The team searched for a seizure signal to measure and monitor. After years of testing and developing, Brain Sentinel created a System that harness sEMG, a biomarker for seizure activity. In February 2017, the SPEAC® System became the first FDA-cleared, non-EEG, physiological, signal-based system for seizure monitoring.

Monitoring Categories

EMG
Self-Report
Sound

How is the device worn?

N/A
External Wearable

Body Placement

The device is worn on the belly of the biceps

How is data transmitted?

Data is securely transmitted over the provided Wi-Fi network.

How is data stored?

How is data from the device stored (e.g., cloud storage)?

Data is stored in a secure cloud environment.

Device Action

Alert System for Caregiver
Alert System for Person Wearing the Device
Other

Device Action Description

Surface electromyography signal, audio, post-ictal assessment, and a seizure diary are available to the physician to understand more about seizure events.

Development Stage

CE Mark
FDA Cleared for Use Case
HIPAA Compliant
On Market
Other

Development Stage Description

De Novo 510(k)

Publications

Yes

Looking for Collaborations

Yes

List of Publications

Szabó, C. Á., Morgan, L. C., Karkar, K. M., Leary, L. D., Lie, O. V., Girouard, M. and Cavazos, J. E. (2015), Electromyography-based seizure detector: Preliminary results comparing a generalized tonic–clonic seizure detection algorithm to video-EEG recordings. Epilepsia, 56: 1432–1437. Doi:10.1111/epi.13083.

Is the device inter operable with other devices?

No

Does the device have a time stamping component?

Yes

Point of Contact

Luke Whitmire, PhD - Luke.Whitmire@BrainSentinel.com

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