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PubMed

Role of AI in Clinical Decision-Making: An Analysis of FDA Medical Device Approvals.

PMID: 40776011 ·

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RevistaStudies in health technology and informatics
Ano
PMID40776011

Resumo

The U.S. Food and Drug Administration (FDA) plays an important role in ensuring safety and effectiveness of AI/ML-enabled devices through its regulatory processes. In recent years, there has been an increase in the number of these devices cleared by FDA. This study analyzes 104 FDA-approved ML-enabled medical devices from May 2021 to April 2023, extending previous research to provide a contemporary perspective on this evolving landscape. We examined clinical task, device task, device input and o

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