Cortechs.ai clears NeuroQuant PET for amyloid scan quantification

Cortechs.ai announced on 18 August 2026 that the US Food and Drug Administration had cleared NeuroQuant PET under 510(k) number K261916. The software reads amyloid PET brain scans and returns standardised uptake value ratios, segmented regions of interest and a Centiloid score, without a human reader tracing the anatomy first.

The cleared tracers are flutemetamol, florbetaben and florbetapir — the three amyloid agents in routine clinical use. The company’s product page lists FDG and flortaucipir output as research use only, which is the line that matters: tau and glucose metabolism are not part of what the FDA cleared here.

What the clearance covers is quantification, not diagnosis. A Centiloid number is a measurement on a common scale, and the argument for automating it is reproducibility — two readers looking at the same scan disagree, and a scale that shifts between sites cannot be tracked over time. That becomes load-bearing now that anti-amyloid therapies are prescribed against imaging thresholds and monitored the same way.

Cortechs.ai is based in Covington, Kentucky, and already sells NeuroQuant for MRI volumetry. This adds the molecular imaging side of the same workflow.