LungAI: An AI Biomarker that Refines Lung-RADS v2022 Triage of Screen-Detected Pulmonary Nodules

Background: The Lung-RADS algorithm standardizes the management of screen-detected pulmonary nodules, but its risk assessment is driven chiefly by nodule size and attenuation. This misallocates a meaningful fraction of patients: a nontrivial share of small malignancies receive 12-month surveillance while large benign nodules proceed to invasive workup. Artificial intelligence (AI) may supply risk information independent of the imaging features Lung-RADS already uses. Methods: We validated LungAI, an investigational deep learning nodule malignancy classifier not yet cleared by the US Food and D

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