Feed

Alphatec Spine's SafeOp 3 neural monitoring system received FDA 510(k) clearance on January 11, 2026 for intraoperative neural monitoring. The device is regulated as a Class II "Stimulator, Electrical, Evoked Response" under regulation number 882.1870, and the clearance came through the traditional 510(k) pathway, with the FDA finding the device substantially equivalent to a predicate device. Alphatec Spine, a maker of spinal surgery devices and technologies, adds SafeOp 3 to its neural monitoring portfolio; the system is intended to let surgeons assess nerve function in real time during procedures and lower the risk of nerve injury.

The FDA cleared the Ceribell Delirium Monitor System on December 8, 2025, finding it substantially equivalent under submission number K251936 through the traditional 510(k) pathway. The agency classifies it as a Neuropsychiatric Interpretative Electroencephalograph Assessment Aid, a Class II device under regulation 882.1440, with neurology as the assigned review panel. The category covers devices that derive neuropsychiatric assessments from EEG signals; Ceribell's earlier products in this line target seizure monitoring in emergency and intensive care settings.

The FDA cleared Hippoclinic's HippoMind, version 1.0, on December 3, 2025, finding it substantially equivalent under submission number K251881 through the traditional 510(k) pathway. The agency classifies it as Non-Normalizing Quantitative Electroencephalograph Software, a Class II device under regulation 882.1400, with neurology as the assigned review panel. Unlike normalizing tools, non-normalizing quantitative EEG software reports an individual's own EEG metrics without reference to a population database.

The FDA cleared Naox Technologies' NX01 on November 25, 2025, finding it substantially equivalent under submission number K251550 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. Reduced-montage systems record with fewer electrodes than a conventional clinical montage, trading spatial resolution for faster setup and the possibility of wearable form factors.

The US Food and Drug Administration cleared Ceribell, Inc.'s Ceribell Infant Seizure Detection Software on November 21, 2025, finding it substantially equivalent under submission number K252070 via the Traditional 510(k) pathway. FDA lists it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation number 882.1400, reviewed by the agency's neurology advisory committee. Neonatal EEG looks markedly different from adult morphology, which has long made automated interpretation difficult; the classification covers software that flags events automatically in full-montage recordings.

The FDA cleared Persyst Development's Persyst 15 EEG Review and Analysis Software on October 31, 2025, finding it substantially equivalent under submission number K252160 through the traditional 510(k) pathway. The agency classifies it as Automatic Event Detection Software for Full-Montage Electroencephalograph, a Class II device under regulation 882.1400, with neurology as the assigned review panel. The category covers software that automatically flags events within full-montage EEG recordings for clinician review.

Nihon Kohden's EEG-1260A Neurofax system, along with its amplifier unit and photic stimulator, received FDA 510(k) clearance on October 9, 2025. The device is a Class II medical device in the neurology specialty, with software for quantitative EEG analysis. The traditional 510(k) clearance indicates substantial equivalence to a legally marketed device.

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.