2025-09-03 00:00 United States Policy & Regulation Regulatory Approval Translated from EN

FDA Clears Forest Devices SignalNED EEG System

Summary The FDA cleared Forest Devices' SignalNED System (Model RE) on September 3, 2025, finding it substantially equivalent under submission number K251726 through the traditional 510(k) pathway. The agency classifies it as a Reduced-Montage Standard Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Forest Devices has applied reduced-montage EEG to prehospital stroke identification, acquiring interpretable signals in settings such as ambulances.

Why it matters Prehospital stroke triage is the rare EEG use case with a hard time constraint and a clear decision attached to the reading, which makes it the strongest commercial argument for reduced-montage hardware outside the hospital.

BCIwiki (bciwiki.com) — Forest Devices, Inc. received an FDA 510(k) decision of Substantially Equivalent for SignalNED System (Model RE) on September 3, 2025, under submission number K251726. The submission followed the Traditional 510(k) clearance pathway.

FDA lists the product under the device classification name Reduced- Montage Standard Electroencephalograph. It is a Class 2 device under regulation number 882.1400, assigned to the Neurology advisory committee. Forest Devices has applied reduced-montage EEG to prehospital stroke identification, acquiring interpretable signals in settings such as ambulances.

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accessdata.fda.gov 2025-09-03

EEG Non-invasive BCI United States

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