FDA Clears VoxNeuro's cfNI Software for EEG-Based Cognitive Assessment
The Toronto company's prescription software scores brain responses recorded during five standard tasks against a reference database, and the FDA summary says it does not provide a diagnosis.
The FDA cleared this device through the 510(k) pathway, which finds it substantially equivalent to a device already on the market. Clearance is not the same as approval.
Key points
- The FDA cleared VoxNeuro's Cognitive Function Neuroimaging (cfNI) software under 510(k) K253015 on June 12, 2026; the company announced it on July 29.
- The software performs post-hoc statistical analysis of EEG and event-related potentials in people aged 18 to 70, with the BNA Platform as its predicate.
- VoxNeuro said it is collecting data in adults aged 71 to 85 for a possible label expansion, which would need a new FDA clearance.
VoxNeuro, a Toronto-based developer of brain assessment software, has received U.S. Food and Drug Administration clearance for its Cognitive Function Neuroimaging (cfNI) software, which analyzes electroencephalogram recordings taken while a person performs standardized tasks, according to the FDA's decision letter and 510(k) summary for K253015. The letter is dated June 12, 2026. The company announced the clearance on July 29, as reported by HospiMedica.
The software is a Class II device under the electroencephalograph regulation, with the common name normalizing quantitative electroencephalograph software. The FDA found it substantially equivalent to the BNA Platform (K202588) from Firefly Neuroscience.
What the software measures
According to the FDA summary, cfNI is used by qualified healthcare professionals for the digital post-hoc statistical analysis of the EEG, including event-related potentials (ERPs), the brain's electrical responses to specific stimuli. It is indicated for people 18 to 70 years old and for use with five tasks: a resting state recording, an auditory oddball task, an auditory go/no-go task, the Continuous Visual Memory Test and the Eriksen flanker task.
The software compares EEG measures with a reference database and produces a report to support interpretation by a qualified user. It also includes functions for recording EEG and presenting synchronized sound and visual stimuli. The summary states: "The device does not provide a diagnosis or clinical interpretation." It is for prescription use only.
The predicate BNA Platform is cleared for ages 12 to 85 and uses three of the same task types. The FDA summary says the two extra tasks in cfNI use the same conventional methods for eliciting, recording and analyzing ERPs as the shared tasks, and that the differences do not raise new questions of safety or effectiveness.
Reference database and next steps
VoxNeuro said the reference database comprises 748 assessments and more than 19,000 data points collected from neurologically healthy adults at sites in the U.S. and Canada, according to HospiMedica. The company said the software works with a range of EEG systems.
VoxNeuro is collecting additional clinical study data in adults aged 71 to 85 to support a possible label expansion, which would require a new FDA submission and clearance, HospiMedica reported. The company has also engaged Stillwater Capital to explore strategic partnering.
"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," Jason Flowerday, VoxNeuro's chief executive, said in the announcement.
Sources
- 510(k) decision letter and summary, K253015 (Cognitive Function Neuroimaging (cfNI) Software), U.S. Food and Drug Administration, June 12, 2026
- FDA Clears Software for Objective Assessment of Cognitive Function, HospiMedica, July 30, 2026