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FDA Review of Radiologic AI Algorithms: Process and Challenges

2024·31 Zitationen·Radiology
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31

Zitationen

4

Autoren

2024

Jahr

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 algorithms to ensure their safety in clinical practice. Then the challenges in maximizing the efficacy of these tools posed by their clinical implementation are discussed.

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Autoren

Institutionen

Themen

Artificial Intelligence in Healthcare and EducationAdvanced X-ray and CT ImagingRadiomics and Machine Learning in Medical Imaging
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