VoxNeuro Receives FDA 510(k) Clearance for Cognitive Function Neuroimaging (cfNI) Software – An Objective EEG/ERP Brain Health Assessment

By: Business Wire

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VoxNeuro Inc. (the Company) today announced that the U.S. Food and Drug Administration 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 ages 18 to 70.

Cognitive Function Neuroimaging (cfNI) is designed to help physicians add objective, neurophysiological data to their cognitive assessments by measuring brain responses during standardized task performance and comparing those outputs against VoxNeuro’s reference database. The FDA-cleared device includes a database of 748 assessments and over 19,000 data points collected from neurologically healthy adults across U.S. and Canadian sites. cfNI software is EEG-interoperable and designed for integration with both innovative and established EEG hardware, supporting flexible deployment across a range of clinical environments.

Event-related potentials, or ERPs, are time-locked changes in brain electrical activity recorded through EEG in response to sensory or cognitive events, and they have long been used in cognitive neuroscience to study functions such as attention, memory, impulse control, and executive control. cfNI is designed to measure and score these ERP responses to standardized task stimuli, giving clinicians a quantifiable and repeatable view of the brain’s neurophysiological response for their interpretation. cfNI was developed with prior commercial insights, together with expert regulatory and reimbursement input, to align its workflow and outputs with existing CMS guidance for the use of EEG in accordance with the software’s cleared label and indications for use.

A recent U.S. burden-of-disease analysis published in JAMA Neurology estimated that approximately 180 million Americans—more than half the population—are affected by at least one disorder of the nervous system, making these conditions the leading cause of disability in the United States. According to the National Alliance on Mental Illness (NAMI), more than 60 million adults experienced mental illness in 2024. Furthermore, figures from the American Migraine Foundation and the Brain Injury Association of America show that more than 45 million individuals suffer from concussion, traumatic brain injury, or migraine. The Alzheimer’s Association reports 7.4 million Americans living with Alzheimer’s dementia, while a Columbia University study in JAMA Neurology estimates that nearly 20 million adults 65 and older have dementia or mild cognitive impairment combined. This is compounded by those fighting neurodegenerative diseases like Parkinson’s disease, which statistics from the Parkinson’s Foundation show is rising sharply as the U.S. population ages. These patients are often managed across neurology clinics, diagnostic imaging centers, TMS clinics, and frontline primary care settings where practical, adjunctive assessments can help support decision-making.

“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, Chief Executive Officer 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. The Company believes cfNI, in the hands of a partner with the right clinical footprint, distribution capabilities, and commitment to brain health, has the potential to unlock materially greater value for patients, providers, and organizations working to address cognitive impairment at scale. Inquiries should be directed to Brad Kerkhof, Vice President, Stillwater Capital, at 905-845-4340 ext. 250 or bkerkhof@stillwatercapital.ca.

About VoxNeuro

VoxNeuro Inc. is a brain health technology company focused on objective neurophysiological assessment through EEG and ERP analysis. The Company’s FDA-cleared Cognitive Function Neuroimaging (cfNI) software is designed to generate standardized EEG and ERP measures that support clinician assessment through neurophysiological data and automated reporting.

Forward-Looking Statements

This press release contains forward-looking statements regarding VoxNeuro’s business strategy, commercialization plans, strategic partner process, and future market opportunities. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied.

VoxNeuro is conducting additional clinical study data collection in adults aged 71 to 85 to support a label expansion for cfNI. Any expansion of the cleared indications would require a new FDA submission and clearance, and no assurance can be given as to outcome.

Regulatory Notice

The Cognitive Function Neuroimaging (cfNI) software is FDA 510(k)-cleared under K253015. The Cognitive Function Neuroimaging (cfNI) software is to be used by qualified healthcare professionals for the digital post-hoc statistical analysis of the human electroencephalogram (‘EEG’), including event-related potentials (‘ERPs’). This device is indicated for use in individuals 18 to 70 years of age, and in conjunction with Resting State, Auditory Oddball, Go No-Go, Continuous Visual Memory Test, and Eriksen Flanker tasks. The device does not provide a diagnosis or clinical interpretation. It is for prescription-use only.

Contact

VoxNeuro Contact
Jason Flowerday, Chief Executive Officer
VoxNeuro Inc.
121 King Street West, Suite 2150
Toronto, Ontario M5H 3T9
PR@voxneuro.com
www.voxneuro.com

Abstract

VoxNeuro receives FDA 510(k) clearance for cfNI software and engages Stillwater Capital to explore strategic partnerships.

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“VoxNeuro’s FDA-cleared Cognitive Function Neuroimaging (cfNI) software brings objective, quantifiable EEG/ERP measurement into the clinic.”

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