新华社北京1月6日电 题：创新破局 国产高端医疗器械崛起正当时 新华社记者戴小河 2025年，国家药监局共批准76个国产创新医疗器械上市，数量连续3年维持高位，覆盖人工智能、 肿瘤放射治疗、生物医用材料等多个前沿领域。 这组国家药监局1月6日公布的数据，清晰勾勒出我国高端医疗器械产业的转型图景。 从曾经的高端诊疗设备依赖进口到如今"中国智造"批量涌现，从临床补充选项成长为核心治疗装 备，从技术跟随模仿迈向源头创新引领，在政策精准赋能、技术持续攻坚、市场需求牵引的共同作用 下，我国高端医疗器械产业正经历从低水平重复到创新提质的蝶变。 近年来，国家药监局持续深化审评审批制度改革，构建起创新特别审查、优先审批等多元化通道， 将监管服务重心向研发阶段前移，形成"提前介入、一企一策、全程指导、研审联动"的工作机制，让创 新产品上市之路更顺畅。 "改革的核心是为创新松绑、为质量护航。"国家药监局器械注册司司长吕玲表示，通过优化特殊审 批程序、完善分类命名原则、健全沟通指导机制等关键举措，对人工智能、医用机器人、新型生物材料 等高端医疗器械给予重点支持。2025年12月又进一步聚焦脑机接口、高端影像设备等核心领域出台优先 ...

内容概要：经导管主动脉瓣置换术（TAVR）是指将人工主动脉瓣在体外压缩组装后，经导管输送并置 入到病变的主动脉瓣处，在功能上完成主动脉瓣置换的一种介入技术。自2002年4月世界首例TAVR、 2010年10月我国首例TAVR完成以来，国内外的TAVR器械研发及临床应用均取得快速发展。TAVR已成 为老年主动脉瓣狭窄（AS）和主动脉瓣反流（AR）患者的重要治疗手段。2024年国内共开展了TAVR 手术17232例（仅统计商业化植入，累计55083例），较2023年增长24.2%。2024年商业化植入TAVR的 前十省份为上海、四川、北京、广东、河南、浙江、山东、陕西、福建、江苏等地。从手术入路方式来 看，经股动脉（TF）途径是经导管主动脉瓣植入术的主要入路，占比为79.9%，其创伤性小，并发症发 生率低。其次为经心尖途径，占比18.4%，其余1.7%为其他入路方式。2021-2024年TAVR的器械成功率 持续上升，至2024年已达到96.16%。同时，TAVR围术期院内死亡率、术后30天死亡率、术后1年死亡 率均呈下降趋势，其他围术期事件的发生率也在稳定下降，显示出TAVR技术在安全性和有效性方面的 不断优化 ...

Core Insights - The Chinese high-end medical device industry is experiencing accelerated innovation due to regulatory measures such as the expansion of the innovation review green channel and the introduction of the "ranking and leading" mechanism [1][2] - The number of approved innovative medical devices in China has reached a historical high, with 65 approved in 2024 and 45 in the first half of 2025, marking an 87.5% year-on-year increase [2] - The domestic high-end medical device sector is making progress in localization, particularly in medical imaging, but still faces challenges in foundational research and reliance on imported components [3][4] Regulatory Measures - The National Medical Products Administration (NMPA) has implemented special reviews for innovative medical devices that are domestically created, internationally leading, and clinically valuable [1][6] - The NMPA is enhancing its legal standards and increasing support for research and development to expedite the market entry of innovative products [1][6] - An expert consultation mechanism has been established to guide companies through the regulatory process, ensuring that innovative medical devices meet safety and efficacy standards [6][7] Industry Progress - The domestic supply chain for medical imaging has improved, with significant advancements in the independent research and production capabilities of core devices [2][3] - Nearly half of the innovative medical devices approved in the first half of 2025 were non-powered devices and in vitro diagnostic (IVD) products, indicating a shift towards more advanced materials and technologies [5] - The NMPA has launched innovation cooperation platforms for artificial intelligence and biomaterials to facilitate the development and approval of cutting-edge medical devices [4][5] Challenges and Opportunities - Despite advancements, the industry still faces "bottleneck" issues in foundational research, software development, and reliance on imported key components [3][4] - The market for high-end medical devices is characterized by high R&D costs and low short-term profitability, which deters other industrial players from entering the sector [4] - New technologies in artificial intelligence and biomaterials present opportunities for further innovation in high-end medical devices [3][5]

Core Viewpoint - Suzhou Jiecheng Medical Technology Co., Ltd.'s "Transcatheter Aortic Valve System" has received approval from the National Medical Products Administration for market launch, marking a significant advancement in innovative medical devices [1][4]. Company Summary - The "Transcatheter Aortic Valve System" is designed for trans-femoral access and features an active positioning clamp for native aortic valve leaflets, along with a bendable delivery system suitable for complex anatomical structures [4]. - This product is intended for patients over 70 years old who have symptomatic severe aortic regurgitation or aortic stenosis and are not suitable for conventional surgical valve replacement [4]. - The system consists of a transcatheter biological valve and a transcatheter delivery system, allowing for valve replacement through minimally invasive techniques without the need for open-heart surgery, significantly reducing surgical risks for elderly patients [4]. Industry Summary - The Jiangsu Provincial Medical Products Administration is implementing the national innovation-driven development strategy, focusing on optimizing the review and approval process for innovative medical devices [4]. - The administration aims to enhance the innovation service environment and improve pre-review mechanisms to address the challenges of long development cycles and high review requirements for Class III innovative medical devices [4]. - Emphasizing breakthroughs in core technologies and addressing critical technical challenges, the administration is committed to accelerating the market launch of innovative products and helping companies build competitive advantages in high-end medical devices [4].

报名：首届全球眼科大会 | 议程更新 报名：首届全球骨科大会 | 议程更新 报名：首届全球心血管大会 | 奖项申报 合作伙伴征集：2025全球手术机器人大会 2025年4月9日， 国家药品监督管理局批准了 金仕生物科技（常熟）有限公司 的 "经导管主动脉瓣膜系统 " （ 国械注准20253130729） 、 北京华脉泰科医疗器械股份有限公司 的 "一体式人工血管术中支架系统" （ 国械注准20253130730） 、 合肥启灏医疗科技有限公司 的 "可降解耳鼻止血绵" （ 国械注准 20253140731） 、 江苏暖阳医疗器械有限公司 的 "血流导向密网支架" （ 国械注准20253130732） 以及 北京万洁天元医疗器械股份有限公司 的 "人工韧带" （ 国械注准20253130733） 创新产品注册申请。 截至目前，我国上市的创新医疗器械累计 343项 。 # 经导管 主动脉瓣膜系统 申请人：金仕生物科技（常熟）有限公司 获批信息 NMPA 批准了金仕生物科技（常熟）有限公司 自主研发的 Prostyle A ® 经导管人工主动脉瓣膜置换系统 - 干法预装可回收输送系统 的 创新产品注册申请。据公司称 ...