FDA Clears Software for Objective Assessment of Cognitive Function

Clinicians evaluating cognitive symptoms often rely on history and behavioral testing, which can lack objective neurophysiological markers. As neurological and psychiatric caseloads grow, standardized measures are needed to complement examination findings. Following FDA clearance, a new system now offers task-based EEG and ERP analytics to deliver quantifiable brain response metrics for adults aged 18 to 70.

VoxNeuro has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its Cognitive Function Neuroimaging (cfNI) software, a prescription-use Software-as-a-Medical-Device (SaMD) that provides digital, post-hoc statistical analysis of electroencephalography (EEG), including event-related potentials (ERPs), in adults aged 18 to 70. The software is designed to help physicians incorporate objective neurophysiological data into cognitive assessments by measuring brain responses during standardized task performance. Its outputs are compared against VoxNeuro’s reference database to support clinician interpretation.

The reference database comprises 748 assessments and more than 19,000 data points collected from neurologically healthy adults across U.S. and Canadian sites. cfNI measures and scores ERP responses to standardized task stimuli, providing a quantifiable and repeatable view of brain responses for clinician review. The software is interoperable with EEG systems and built to integrate with both established and newer hardware, supporting deployment across varied clinical environments.

The software’s workflow and outputs were aligned with existing CMS guidance on EEG in accordance with the cleared label and indications. VoxNeuro is also collecting additional clinical study data in adults aged 71 to 85 to support a potential label expansion, which would require a new FDA submission and clearance, with no assurance given as to outcome. The company has engaged Stillwater Capital to explore strategic partnering.

“FDA clearance for cfNI marks an important milestone for VoxNeuro and reflects almost a decade of work by our team to translate established ERP science into an objective clinical software platform that measures and scores ERPs to support and inform clinicians. We're now focused on scaling, and looking for the right partner to move cfNI into every setting that needs an objective measure of brain function,” said Jason Flowerday, Chief Executive Officer of VoxNeuro.

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