Cortechs.ai Announces FDA Clearance for NeuroQuant® PET: Advancing Molecular Imaging for Cognitive Impairment

COVINGTON, Ky., Aug. 18, 2026 /PRNewswire/ -- NeuroQuant ® PET has received FDA 510(k) clearance (K261916) for PET. NeuroQuant PET ® aids physicians in the evaluation of patient pathologies and the clinical interpretation of PET performed for the assessment of cognitive impairment and other neurological conditions.

As molecular imaging plays an increasingly central role in the diagnosis and management of Alzheimer’s disease and related neurodegenerative disorders, the demand for standardized, objective PET analysis continues to grow. NeuroQuant® PET is designed to deliver fully automated quantification, regional analysis, and structured reporting directly into routine clinical workflows.

“Automated quantitative PET imaging represents the next frontier in precision and personalized medicine for Alzheimer’s disease and related neurocognitive disorders. These new technological advancements are enabling the shift from phenotype-based assessment to a biological, biomarker-driven approach in assessing neurodegenerative disease. I am excited about the role NeuroQuant PET will play in shaping the future of how these conditions are understood and managed.” said Dr. Ana Franceschi, M.D., Ph.D.

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