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PubMed

FDA Review of Radiologic AI Algorithms: Process and Challenges.

PMID: 38165243 · 2024

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JournalRadiology
Year2024
PMID38165243

Abstract

A Food and Drug Administration (FDA)-cleared artificial intelligence (AI) algorithm misdiagnosed a finding as an intracranial hemorrhage in a patient, who was finally diagnosed with an ischemic stroke. This scenario highlights a notable failure mode of AI tools, emphasizing the importance of human-machine interaction. In this report, the authors summarize the review processes by the FDA for software as a medical device and the unique regulatory designs for radiologic AI/machine learning algorith

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