本次申请的企业主要集中在上海、江苏、广东等省市。申请的产品涉及到11个产品器械分类，主要集中在有源手术器械、无源植入器械，无源手术器械等 类别中。 资料来源：药监局官网、药智医械数据 2025年11月，国家药监局和地方药监局共公示了26款器械进入创新医疗器械特别审查通道。其中国家局发布了10款产品，地方药监局发布了16款产品。 资料来源：药监局官网、药智医械数据 资料来源：药监局官网、药智医械数据 下附26款进入创新通道的器械名单。 2025年11月进入创新器械审批通道的器械 | 创新器械名称 | 申请企业 | 发布日期 | 审核机构 | | --- | --- | --- | --- | | 肾动脉超声消融系统 | 深圳迈微医疗科技有限公司 | 2025/11/28 | 国家药品监督管理局 | | 双极高频超声双输出手术设备 | 上海益超医疗器械有限公司 | 2025/11/28 | 国家药品监督管理局 | | 肾部穿刺手术导航定位系统 | 深圳惟德精准医疗科技有限公司 | 2025/11/11 | 国家药品监督管理局 | | 经导管主动脉瓣 置换手术辅助系统 | 智程医疗科技(嘉兴)有限公司 | 2025 ...

深圳硅基传感科技有限公司是一家 专注电化学传感技术与持续葡萄糖监测（CGM）系统研发 的高科技企业， 团队在微型传感器设计、柔性贴肤检测技术和移动健康数据管理等方面具备积累。公司开发的连续监测平台覆 盖葡萄糖、酮体等代谢指标，旨在为糖尿病及代谢异常人群提供更便捷的动态监测方案，并在消费级与医疗级 传感产品方面同步推进。 3 . 产 品名称 ： 生 物 型 人 工 血管 2025年11月28日，国家药品监督管理局公布了 创新医疗器械特别审查申请审查结果公示（2025年第12号） ， 有7款产品进入创新通道 。 1 . 产 品名称 ： 经 导 管 主 动 脉瓣置换手术辅助系统 申请人：智程医疗科技（嘉兴）有限公司 智程医疗科技（嘉兴）有限公司成立于2023年，总部位于浙江嘉兴，是一家 专注经导管介入治疗辅助系统及 手术机器人研发 的创新型医疗器械企业。公司围绕结构性心脏病和经导管瓣膜介入的复杂操作场景，布局导 管输送、精准导航、远程操控等核心技术，致力于提升TAVR 等术式中的操作一致性与安全性，并已与多家心 血管中心开展工程化验证与技术合作。 2 . 产 品名称 ： 持 续 葡 萄 糖 与酮体监测系统 申请人： ...

Core Insights - The Yangtze River Delta (YRD) region's new energy vehicle (NEV) industry achieved significant production in Q1 2025, with over 840,000 vehicles produced, accounting for nearly 30% of the national total, continuing its status as a production hub [1] - The region is transitioning from the "first half of electrification" to the "second half of intelligence," driven by leading companies like CATL, NIO, and Tesla, but faces challenges such as overcapacity, declining penetration rates, and regional collaboration barriers [1][5] Industry Structure and Collaboration - The YRD NEV industry is moving from "local breakthroughs" to a "system layout," with clear functional positioning among Jiangsu, Shanghai, Zhejiang, and Anhui, forming a complete industrial chain from vehicles to batteries, chips, and components [2] - Shanghai is building a head ecosystem around vehicle manufacturing and intelligent driving, with Tesla's Shanghai Gigafactory expected to deliver 910,000 vehicles in 2024, representing nearly half of global capacity [2] - Jiangsu focuses on power batteries, housing over 190 key enterprises, including CATL and BYD, establishing a leading lithium battery production base [2] - Zhejiang's NEV industry cluster is projected to exceed 1 trillion yuan in revenue by 2024, growing by 19.5%, but faces challenges due to reliance on small private enterprises and limited financing [3] - Anhui's NEV production is expected to reach 1.684 million units in 2024, a 94.5% increase, with policies driving growth and establishing a "vehicle-software-testing" ecosystem [3] Challenges in Collaboration and Financial Support - The YRD NEV industry faces collaboration obstacles, including inconsistent data standards and unreasonable capital allocation, hindering cross-regional operations and testing [3][4] - Local industrial funds prioritize local projects, limiting support for cross-regional enterprises, exemplified by Hefei's targeted support for NIO, which has not significantly impacted other cities [4] Transition to Intelligent Systems - The global NEV market is experiencing a slowdown, with penetration rates dropping from 53.2% to 41.5% between September 2024 and January 2025, indicating a need for a shift from manufacturing to intelligent systems [5] - The YRD region has a solid foundation for intelligent transformation, with Shanghai leading in high-end electronic architecture and autonomous driving testing platforms [5][6] - However, the software ecosystem remains fragmented, with strong vehicle and chip companies but weak middleware, limiting the formation of a complete ecosystem [6][7] - To advance the NEV industry into the "second growth curve," the YRD must enhance software collaboration and public support capabilities [7]