
VoxNeuro received FDA 510(k) clearance for its cfNI software, which analyses EEG and event-related potentials to give clinicians an objective measure of cognitive function. The prescription-use software scores a patient's brain responses during standardised tasks and compares them against a reference database of neurologically healthy adults. VoxNeuro positions cfNI as a repeatable physiological complement to questionnaires and effort-based tests. The company is collecting data to support a potential label expansion to older adults.