FDA Clears Cortechs.ai's NeuroQuant PET

Aug. 18, 2026 — Cortech.AI's 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.

The platform provides atlas-based quantification for amyloid PET tracers, generating standardized uptake value ratios (SUVRs) and structured reports to support consistent, data-driven interpretation. NeuroQuant PET segments regions of interest and quantifies Centiloids for commonly used amyloid PET tracers flutemetamol, florbetaben, and florbetapir, enabling standardized comparison across tracers and imaging systems.

Compatible with PET-CT, PET-MR, and PET-only workflows, NeuroQuant® PET features fully automated processing and PACS-ready outputs designed to integrate quantitative metrics into existing workflows.

Future Exansion with FDA Clearance

"NeuroQuant PET reflects our commitment to advancing quantitative imaging in dementia care, giving clinicians objective, reproducible measurements they can trust, so patients get earlier answers and more confident treatment decisions" said Kyle Frye, CEO of Cortechs.ai. "With FDA 510(k)-clearance status, we look forward to expanding access to standardized PET quantification that supports precision medicine in Alzheimer's disease and related dementias."