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  • Paper: FDA should develop labeling standards for AI-powered medical devices

    Jul 9, 2025 8:45 am by Phil CicioraInsights
    Sara Gerke argues that the Food and Drug Administration should prioritize the development of labeling standards for AI-powered medical devices in much the same way that there are nutrition facts labels on packaged food. Photo by Fred Zwicky

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    • Sara Gerke argues that the Food and Drug Administration should prioritize the development of labeling standards for AI-powered medical devices in much the same way that there are nutrition facts labels on packaged food. Photo by Fred Zwicky

    The regulatory framework for AI-based medical devices needs to be improved to ensure transparency and protect patients’ health, says Sara Gerke, an expert in the ethical and legal challenges of artificial intelligence for health care.