FDA clears automated PET software that puts a number on amyloid burden

Cortechs.ai received FDA 510(k) clearance (K261916) for NeuroQuant PET on 18 August 2026. The software segments regions of interest on amyloid PET scans and reports standardised uptake value ratios and Centiloid values for the flutemetamol, florbetaben and florbetapir tracers, so a result can be compared across tracers and scanners rather than read by eye. It produces structured reports and fits PET-CT, PET-MR and PET-only workflows.

What it means Regulatory clearance is what decides whether an imaging model reaches a real clinic, and Centiloid output is what makes one hospital’s number comparable to another’s.