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

Core Viewpoint - Sanofi Biologics has voluntarily withdrawn its 510(K) application for the first-generation continuous glucose monitoring system iCan i3 to expedite the entry of the next-generation solution into the U.S. market [1] Group 1: Product Development - The first-generation continuous glucose monitoring system iCan i3 has met the performance standards required by the FDA for iCGM, but the clinical data completed is statistically insufficient to demonstrate substantial equivalence to recently approved iCGM products [1] - The company has decided to focus resources on advancing the next-generation product due to the potential need for additional clinical research [1] Group 2: Regulatory Achievements - The latest generation continuous glucose monitoring system iCan i6 has obtained CE-MDR certification in the European Union [1] - The company aims to combine the high accuracy and reliability of the i3 system with greater usability and affordability to continue supporting global continuous glucose monitoring system users [1]