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

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 the detection of nodules of size 4-30 mm.
• The software provides characterization involving features of texture (solid, part-solid, and ground glass), spiculation status, and calcification status, plus quantification of volume and diameter.
• In a multi-reader study of 300 cases, AI assistance improved reader accuracy for calcification from 51.85% to 66.11%, and for texture from 46.17% to 60.79%.
• The device's predicate is actually a breast tomosynthesis software, Lunit INSIGHT DBT v1.1, demonstrating how FDA product codes drive regulatory strategy over anatomical focus.
• The clearance includes a Predetermined Change Control Plan allowing for Data-Driven Retraining with new datasets without requiring a completely new 510(k) submission.
• The software is explicitly not intended to be used as a replacement for a complete interpreting physician's review or clinical judgment.

Source: qCT Lung (v1.0) - U.S. Food and Drug Administration, 2026

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This episode is an AI-generated conversation summarising a public document; the hosts' voices are synthetic. It is for information only and is not medical advice. Always refer to the original source.

Full transcript: https://ai-in-medicine-podcast.vercel.app/episodes/when-ai-upgrades-chest-cts-inside-the-fda-clearance-of-qct-lung-2a93ed