Cortechs.ai has won FDA 510(k) clearance for NeuroQuant PET, an automated analysis platform that quantifies amyloid PET scans to support evaluation of cognitive impairment and other neurological conditions.
The clearance, announced August 18, lets the software generate standardized uptake value ratios and Centiloid scores for three widely used amyloid tracers, flutemetamol, florbetaben and florbetapir, enabling comparison across tracers and imaging systems. Fully automated processing means radiologists can push PET data through the pipeline without manual contouring, with structured reports ready for PACS.
The system works with PET-CT, PET-MR and PET-only setups, and the company positions it as a step toward biomarker-driven rather than symptom-based diagnosis of Alzheimer’s disease and related dementias. As molecular imaging plays a larger role in dementia care, demand for objective, reproducible quantification is climbing.
CEO Kyle Frye said the clearance gives clinicians reliable measurements for earlier answers and more confident treatment decisions. Radiologist Ana Franceschi of the platform’s advisory work called automated quantitative PET the next frontier in precision medicine for neurocognitive disorders.
The clearance extends Cortechs.ai’s product line beyond its MRI-based NeuroQuant brain analysis suite into molecular imaging, a market the company says is growing quickly as new Alzheimer’s therapies require clearer evidence of amyloid burden.
