TRUE VIE Continuous Glucose Monitoring System
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三诺生物:撤回持续葡萄糖监测系统美国FDA注册申请
news flash· 2025-07-28 08:33
Core Viewpoint - Sanofi Biologics has received confirmation from the U.S. Food and Drug Administration (FDA) regarding the withdrawal of its registration application for the first-generation Continuous Glucose Monitoring (CGM) product, TRUE VIE Continuous Glucose Monitoring System, which was intended for diabetes management [1] Group 1 - The product aimed to replace fingerstick blood glucose testing for diabetes treatment decisions [1] - The decision to withdraw the registration application was influenced by FDA's supplementary requirements and market changes [1] - The withdrawal of the registration application is a carefully considered decision by the company and will not have a significant impact on its current operations [1]