FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Brain Sentinel’s Portable Seizure Monitor Gains Expanded Clearance

June 6, 2019

The FDA has granted a further 510(k) clearance for Brain Sentinel’s SPEAC system, a portable device that uses surface electromyography technology for seizure monitoring and alerts.

The device’s expanded indication gives physicians the capability to prescribe customized options for continuous event recording that can span days, weeks or months.

The data SPEAC records can be used by physicians to quantify and qualify the types of seizure events patients go through, instead of depending on patient and caregiver reports.

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