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。鉴于可能需要额外开展临床研究,公司决定将资源聚焦于下一代产品的推进。三诺生物表示,在最新一代持续葡萄糖监测系统iCan i6已取得欧盟CE-MDR认证的基础上,公司正专注于将i3系统已验证的高准确性和可靠性,结合更高的使用便捷性与可负担性,持续支持全球持续葡萄糖监测系统用户。
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