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NeuroQuant PET Approved The FDA has approved NeuroQuant PET, a program that translates amyloid PET scans into a common scale. On August 12, the FDA granted a "Substantially Equivalent" decision for NeuroQuant PET under the K261916 application. The program automatically generates a quantitative report for amyloid PET scans in patients with cognitive impairments and other neurological conditions. The amyloid PET scan shows where a tracer accumulates in the brain, binding to amyloid deposits. However, the resulting number depends on the tracer, scan time, device, and calculation method, making it difficult to compare results from different studies and clinics. The Centiloid scale translates these results into common units, with zero corresponding to the average value in young individuals with high confidence in the absence of amyloid, and 100 corresponding to the average value in typical Alzheimer's disease patients. NeuroQuant PET performs this translation for a given scan, highlighting brain regions, calculating SUVr, and adding the Centiloid value to a structured report. According to Cortechs.ai, the FDA approval applies to amyloid reports for flutemetamol, florbetaben, and florbetapir. The scale, created for research comparison, becomes part of the automatic clinical report, supplementing the image with a number that is equally readable across different tracers and analysis methods. 🔗 Read original →