VoxNeuro has received FDA 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. The cfNI software is EEG-interoperable and designed to integrate with both innovative and established EEG hardware, supporting flexible deployment across clinical environments. The software is indicated for use in individuals aged 18 to 70 and includes a database of 748 assessments and over 19,000 data points collected from neurologically healthy adults in the U.S. and Canada. The FDA-cleared device is to be used by qualified healthcare professionals for the post-hoc analysis of EEG and ERPs, and it does not provide a diagnosis or clinical interpretation. VoxNeuro is also conducting additional clinical data collection in adults aged 71 to 85 to support a future label expansion, which would require another FDA submission and clearance. The cfNI software is listed under FDA 510(k) K253015.
Sources:
VoxNeuro Receives FDA 510(k) Clearance for Cognitive Function ...
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Search the Releasable 510(k) Database
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Objective Assessment System for Cognitive Function - NCBI Bookshelf
510(k) Premarket Notification - accessdata.fda.gov