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FDA-authorized oncology artificial intelligence and machine learning devices and their clinical evidence: A cross-sectional analysis
0
Zitationen
4
Autoren
2026
Jahr
Abstract
Oncology AI/ML device authorizations are concentrated in imaging and radiation oncology domains, with publicly described clinician-in-the-loop and prospective evaluations remaining uncommon overall, though higher-tier evidence was more frequent among CAD devices designed to directly aid clinician interpretation. Evidentiary expectations should be calibrated to device function and clinical risk, with stronger evaluation requirements for devices that directly shape decision-making.
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