Cortechs.ai Gains FDA Clearance for NeuroQuant PET

COVINGTON, Ky., August 18, 2026

FDA-Cleared PET Platform Advances Quantitative Imaging

The FDA clearance expands the clinical role of NeuroQuant PET by providing physicians with automated tools for analyzing PET examinations. The platform uses atlas-based quantification to evaluate amyloid PET imaging and generates standardized uptake value ratios (SUVRs) alongside structured reports. It can also quantify Centiloids for commonly used amyloid PET tracers, including flutemetamol, florbetaben and florbetapir. By providing standardized quantitative measurements, the platform is designed to support more consistent interpretation of molecular imaging results across different imaging environments. This capability is particularly relevant to cognitive impairment, where objective biomarkers can complement clinical assessment and contribute to a more biologically informed understanding of neurodegenerative disease. The company said the technology reflects the increasing shift from phenotype-based assessment toward biomarker-driven evaluation in Alzheimer’s disease and related neurocognitive disorders.

Automated Analysis Integrates Into Clinical Workflows

NeuroQuant PET is designed for fully automated processing, with compatibility across PET-CT, PET-MR and PET-only workflows. The platform generates PACS-ready outputs, allowing quantitative imaging metrics and structured information to be incorporated into existing radiology workflows. This approach is intended to reduce the need for manual image analysis while providing clinicians with reproducible measurements that can support interpretation of complex PET examinations. The system’s regional segmentation capabilities allow specific areas of interest to be analyzed and quantified, helping clinicians evaluate molecular imaging findings in a standardized format. By combining automated processing with structured reporting, Cortechs.ai aims to make quantitative PET analysis more accessible within routine clinical practice. Such tools may become increasingly valuable as PET imaging continues to play a role in evaluating neurological disorders and identifying biological characteristics associated with cognitive impairment.

NeuroQuant PET Targets Precision Medicine in Neurology

The FDA clearance comes as molecular imaging becomes increasingly important in the evaluation and management of Alzheimer’s disease and other neurodegenerative conditions. Cortechs.ai said NeuroQuant PET is intended to provide clinicians with objective and reproducible measurements that can support more informed assessment and treatment decisions. The company is focused on applying artificial intelligence and advanced imaging technologies to neurological and other medical conditions, including Alzheimer’s disease, epilepsy, multiple sclerosis, brain trauma, tumors and prostate cancer. The introduction of FDA-cleared quantitative PET capabilities further expands the company’s medical imaging technology portfolio. For clinicians, standardized measurements of amyloid PET imaging could support more consistent interpretation of scans and help integrate quantitative biomarkers into clinical decision-making. While the platform is designed to assist physicians in evaluating PET examinations, clinical decisions remain dependent on the overall patient presentation and appropriate medical interpretation. The FDA clearance nevertheless represents a significant MedTech and medical imaging milestone, highlighting the growing convergence of AI, quantitative imaging and precision medicine in neurological care.

Source: Cortechs.ai press relese