三诺生物回应主动撤回首代持续葡萄糖监测系统美国上市申请：决定将资源聚焦下一代产品推进

格隆汇2025-07-30

据界面，7月30日，三诺生物回应称，7月24日，公司主动撤回了首代持续葡萄糖监测系统 iCan i3系统的510(K)申请。此项战略决策旨在加快下一代解决方案进入美国市场的进程。三诺生物表示，尽管根据分析结果，首代持续葡萄糖监测系统iCan i3已满足美国食品药品监管局（FDA） iCGM所要求性能标准，但其已完成的临床数据在统计效能上仍不足以证明其与FDA最近批准的iCGM产品具备实质等同性。...

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