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.
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.
"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."
About Cortechs.ai
Cortechs.ai is the leader in AI applications in radiology, leveraging advanced technologies in medical imaging to enhance disease screening and timely assessment, empowering healthcare providers to deliver better outcomes for patients. The company develops and markets innovative medical imaging solution software for assessing neurological disorders such as Alzheimer's disease, epilepsy, multiple sclerosis, brain trauma, tumors and prostate cancer, helping clinicians identify and monitor clinically significant cases. Cortechs.ai's industry-leading imaging solutions offer radiologists, oncologists, and urologists streamlined, cost-effective tools to assist in the assessment of brain and prostate health, including cancer evaluation. Visit www.cortechs.ai for additional insights and follow us on Twitter, LinkedIn, and Facebook.
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