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Announcing New FDA 510(k) Clearance

The SPEAC® System can now provide even more objective sEMG data for physicians.

LATEST GENERATION SPEAC SYSTEM

The Sensing, Portable sEMG, Analysis and Characterization (SPEAC) System with FDA 510(k) Clearance is the first diagnostic platform that continuously records, analyzes, stores, and reports physiologic data for review by a physician to characterize seizure events providing even more objective sEMG data for physicians to consider.

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CLINICALLY VALIDATED

The SPEAC System is becoming the industry-standard portable diagnostic platform for people living with epilepsy. The latest release offers physician-prescribed customizable options ensuring continuous event recording over days, weeks, or months. Using the SPEAC-recorded physiologic sEMG and audio data, physicians may quantify and qualify the types of seizure events their patients' experience.

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The SPEAC System is the first diagnostic platform that continuously records, analyzes, stores, and reports physiologic data for review by a physician to characterize seizure events, providing even more objective sEMG data for physicians to consider.

Indications for Use

The SPEAC® System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The System records and stores surface electromyographic (sEMG) data for subsequent review by a trained healthcare professional . . .

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The Story of Brain Sentinel

At Brain Sentinel, we're pioneering the use of sEMG technology to help improve the lives of people living with epilepsy. We collaborate with industry-renowned epileptologists and clinical neurophysiologists to address unmet healthcare needs, improve patient outcomes, and enhance lives.

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