ICU向けAI医療機器36製品：米国と欧州の規制承認と臨床課題

MedAI Digest (JA)
MedAI Digest (JA)
ICU向けAI医療機器36製品：米国と欧州の規制承認と臨床課題
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集中治療室（ICU）向けのAI医療機器は米国と欧州で36製品が商用化されており、大半が予測・評価機能を備えていますが、規制承認と臨床的な有効性の証明は必ずしも一致していません。

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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