Cortechs.ai announced on August 18, 2026, that NeuroQuant® PET received FDA 510(k) clearance, submission K261916.
The software is designed to help physicians evaluate pathology and interpret PET scans used in assessing cognitive impairment and other neurological conditions.
NeuroQuant PET provides automated quantification of amyloid PET images, including regional analysis and Centiloid scoring to support interpretation of recognized biomarkers.
The clearance marks a move toward more standardized, quantitative molecular imaging in dementia and cognitive-impairment evaluation.
Cortechs.ai notes that some additional NeuroQuant PET outputs remain for research use only and are not FDA-cleared or approved.
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