FDA Clears VoxNeuro's EEG-Based Cognitive Assessment Software

The FDA has granted 510(k) clearance to VoxNeuro's Cognitive Function Neuroimaging (cfNI) software, a prescription-use software-as-a-medical-device that performs post-hoc statistical analysis of EEG, including event-related potentials (ERPs), in adults aged 18 to 70. The clearance, filed under K253015, allows cfNI to be marketed as an adjunct to standard cognitive assessment rather than a standalone diagnostic tool; the device does not provide a diagnosis or clinical interpretation on its own.¹

ERPs are time-locked EEG responses to sensory or cognitive tasks that have long been used in cognitive neuroscience to study attention, memory, and executive function, with specific waveform components, such as the N100, N200, and P300, reflecting different aspects of processing speed and cognitive control.² cfNI scores a patient's ERP responses against a reference database built from 748 assessments and more than 19,000 data points collected from neurologically healthy adults across US and Canadian sites.¹ The software is designed to work with multiple EEG hardware systems rather than requiring a single proprietary headset, distinguishing it from some competing platforms.

READ MORE: Alzheimer Agent PMN310 Shows No ARIA-E in Six-Month Interim Analysis of Phase 1b AD Trial

VoxNeuro's underlying approach isn't new. A 2023 Canadian health-technology assessment reviewing the company's earlier CORE and CHAMP platforms noted that objective, EEG-based cognitive scoring could be useful in conditions ranging from traumatic brain injury to dementia, particularly for patients unable to complete traditional behavioral testing, but also found no published evidence at the time specifically evaluating the effectiveness of VoxNeuro's own system.² cfNI represents the company's first FDA-cleared iteration built specifically around statistical analysis of ERP data.

"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," Jason Flowerday, chief executive officer of VoxNeuro, said in a statement.¹

The company pointed to the scale of potential demand: a recent JAMA Neurology analysis estimated that roughly 180 million Americans are affected by at least one neurologic disorder, making such conditions the leading cause of disability in the US.^1,3

VoxNeuro is collecting additional data in adults aged 71 to 85 to support a future label expansion, which would require a separate FDA submission. The company has also engaged Stillwater Capital to explore a potential acquisition or strategic partnership to scale distribution of the software.¹

REFERENCES
1. VoxNeuro Receives FDA 510(k) Clearance for Cognitive Function Neuroimaging (cfNI) Software - An Objective EEG/ERP Brain Health Assessment. News release. VoxNeuro Inc. July 29, 2026. Accessed July 31, 2026. https://www.businesswire.com/news/home/20260729837089/en/VoxNeuro-Receives-FDA-510k-Clearance-for-Cognitive-Function-Neuroimaging-cfNI-Software---An-Objective-EEGERP-Brain-Health-Assessment
2. Xie W, McGill SC. Objective Assessment System for Cognitive Function. CADTH Horizon Scan. Ottawa, ON: Canadian Agency for Drugs and Technologies in Health; 2023 May. Report No.: EN0046. PMID: 37643268. https://www.ncbi.nlm.nih.gov/books/NBK594404/
3. Ney JP, Steinmetz JD, Anderson-Benge E, et al. JAMA Neurol. 2026;83(1):20-34. Doi: 10.1001/jamaneurol.2025.4470 https://jamanetwork.com/journals/jamaneurology/fullarticle/2841765