When AI Upgrades Chest CTs: Inside the FDA Clearance of qCT Lung

Podcast: AI in Medicine - curated summaries making complex issues easy to understand · Mike Rawson

Opublikowano: 2026-10-23

The FDA recently cleared Qure.ai's qCT Lung (v1.0), an AI tool designed to detect, characterize, and quantify lung nodules in adult screening CT scans. Maya and Sam unpack the regulatory strategy of using a breast imaging predicate, dive into the standalone and multi-reader study numbers, and explore the inclusion of a Predetermined Change Control Plan. This episode is a must-listen for clinicians curious about AI workflow integration and industry leaders tracking regulatory pathways for diagnostic software. Key points qCT Lung is cleared as a concurrent reader for adult lung cancer screening CT scans, assisting in...