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AI 주도 소프트웨어로서 의료 장치 (SaMD)의 임상 평가 및 규제 프레임워크의 발전

PMID: 39698124 · 2024-10-23

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학술지IEEE open journal of engineering in medicine and biology

연도2024-10-23

PMID39698124

초록

Owing to the rapid progress in artificial intelligence (AI) and the widespread use of generative learning, the problem of sparse data has been solved effectively in various research fields. The application of AI technologies has resulted in important transformations in healthcare, particularly in radiology. To ensure the high quality, safety, and effectiveness of AI and machine learning (ML) medical devices, the US Food and Drug Administration (FDA) has established regulatory guidelines to suppo

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