FDA OKs VoxNeuro’s Objective EEG/ERP Brain Health Assessment Software

VoxNeuro announced U.S. Food and Drug Administration (FDA) 510(k) clearance for its Cognitive Function Neuroimaging (cfNI) software, a prescription-use Software as a Medical Device that provides post-hoc statistical analysis of EEG and event-related potentials (ERPs) in adults ages 18 to 70.

cfNI is designed to add objective neurophysiological data to cognitive assessments by measuring brain responses during standardized tasks and comparing them with VoxNeuro’s reference database. The company’s FDA-cleared database includes 748 assessments and more than 19,000 data points from neurologically healthy adults in the U.S. and Canada. The EEG-interoperable software is designed to integrate with both established and emerging EEG systems across clinical settings.

ERPs are EEG-measured changes in brain activity triggered by sensory or cognitive events and are used to evaluate functions such as attention, memory and executive control. cfNI measures and scores these responses to provide clinicians with quantifiable, repeatable data for interpretation.

The clearance comes amid a growing burden of neurological and cognitive disorders. An estimated 180 million Americans have at least one nervous system disorder, while millions more are affected by mental illness, migraine, traumatic brain injury, Alzheimer’s disease and other neurodegenerative conditions. cfNI is intended to support clinical decision-making across neurology practices, diagnostic imaging centers, TMS clinics and primary care settings.

“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,” said Jason Flowerday, CEO of VoxNeuro. “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.”

VoxNeuro has engaged Stillwater Capital Corporation to support its M&A process and search for a strategic acquirer.