Article ; Online: FDA Review of Radiologic AI Algorithms: Process and Challenges.
2024 Volume 310, Issue 1, Page(s) e230242
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 ... ...
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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MeSH term(s) | United States ; Humans ; Artificial Intelligence ; United States Food and Drug Administration ; Algorithms ; Software ; Machine Learning |
Language | English |
Publishing date | 2024-01-01 |
Publishing country | United States |
Document type | Journal Article ; Review |
ZDB-ID | 80324-8 |
ISSN | 1527-1315 ; 0033-8419 |
ISSN (online) | 1527-1315 |
ISSN | 0033-8419 |
DOI | 10.1148/radiol.230242 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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