今年以来，多款AI医疗器械产品获得由国家药品监督管理局（NMPA）颁发的市场准入凭证，即第三类医疗器械注册证（以下简称“三类证”）。记者了解到，如今医疗器械行业的应用重心正从传统辅助诊断向辅助治疗延伸；产品层面，软硬件集成化迭代节奏加快，逐步摆脱外挂式AI、单一单机产品形态，同步推动企业跳出软硬件单品售卖思路，积极探索多元可持续商业化落地路径。 多款AI医械产品获“三类证” 2026年年初，...
Source Link今年以来，多款AI医疗器械产品获得由国家药品监督管理局（NMPA）颁发的市场准入凭证，即第三类医疗器械注册证（以下简称“三类证”）。记者了解到，如今医疗器械行业的应用重心正从传统辅助诊断向辅助治疗延伸；产品层面，软硬件集成化迭代节奏加快，逐步摆脱外挂式AI、单一单机产品形态，同步推动企业跳出软硬件单品售卖思路，积极探索多元可持续商业化落地路径。 多款AI医械产品获“三类证” 2026年年初，...
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