集中治疗病房的AI医疗设备：美欧监管生态与临床采用的鸿沟

MedAI Digest (ZH)
MedAI Digest (ZH)
集中治疗病房的AI医疗设备：美欧监管生态与临床采用的鸿沟
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一项对美国与欧盟地区ICU（集中治疗病房）AI医疗设备的系统综述发现，尽管已有36个此类产品获得商业化许可，但监管批准与临床实证之间存在显著鸿沟。当前的监管框架可能无法适应自适应和生成式AI系统的需求。

Original paper: The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units. — NPJ digital medicine. 10.1038/s41746-026-02609-2

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