近年来，从创新审查绿色通道扩容到"揭榜挂帅"机制发布，监管创新加速了中国高端医疗器械的创新转 化。根据国家药监局统计，今年上半年我国创新医疗器械获批数量创历史新高。 国家药监局日前在"优化全生命周期监管支持高端医疗器械创新发展有关举措"（下称"有关措施"）中明 确，对符合要求的国内首创、国际领先，且具有显著临床应用价值的高端医疗器械继续实施创新特别审 查，进一步优化创新审查工作。 10月下旬，国家药监局官网再次刊文称，将进一步完善法律标准体系，加大研发创新支持力度，提高审 评审批质效，"加快创新产品上市步伐"。 当更多原创性的国产医疗器械产品进入研发和审评审批阶段，企业越来越关注：如何避免在创新特别审 查通道出现"扎堆申报，获批寥寥"的情况？针对技术发展前沿且涉及多学科、多技术知识复合交叉的领 域，监管又能否跟上创新步伐？专家咨询机制如何推动审评前置，进而避免企业在研发阶段走弯路？ 高端医疗器械"国产化"进展 高端医疗器械包括医用机器人、高端医学影像设备、人工智能医疗器械和新型生物材料医疗器械等领 域。 针对这些短板弱项，已有地方开展系统部署。在9月发布的《上海市促进高端医疗器械产业全链条发展 行动方案》中， ...

Group 1 - As of August 4, 2025, the stock price of Xinmai Medical is 113.44 yuan, an increase of 3.74 yuan or 3.41% from the previous trading day [1] - On the same day, the trading volume was 29,521 hands, with a transaction amount of 328 million yuan [1] - Xinmai Medical primarily engages in the research, development, production, and sales of interventional medical devices for aorta and peripheral blood vessels [1] Group 2 - In Q1 2025, the company achieved operating revenue of 332 million yuan and a net profit of 130 million yuan [1] - As of July 31, 2025, Xinmai Medical has repurchased a total of 1.09 million shares, accounting for 0.89% of the total share capital, with a repurchase amount of 113 million yuan [1] - The repurchase price range was between 84.26 yuan/share and 119.82 yuan/share [1] Group 3 - On August 4, 2025, the net inflow of main funds was 29.44 million yuan, while the net outflow over the past five days was 24.67 million yuan [1]

Group 1: Advanced Equipment Development - Guangdong Province allocated 38.86 million yuan for the first set of major technological equipment, focusing on intelligent robots and new energy vehicles [1] - The advanced equipment sector shows strong industrial clustering, with significant product development and enhanced manufacturing capabilities [1] - Guangdong has cultivated 4 competitive national-level small and medium-sized enterprise clusters and 2 trillion-yuan international competitive industrial clusters in the machinery sector [1] Group 2: Innovations in Aviation - EHang received the first operational qualification certificate for manned civil unmanned aerial vehicles in China, marking a significant step towards commercializing low-altitude manned services [2] - The AG600 amphibious firefighting aircraft developed by AVIC has also received its type certificate, indicating successful market entry [2] - Guangdong plans to accelerate the development of advanced equipment, implementing policies to support new projects and enhance industry collaboration [2] Group 3: Biopharmaceutical Innovations - In Q1, Guangdong approved 3 first-class innovative drugs and 2 third-class innovative medical devices, nearing half of the total approvals for the previous year [3] - The province aims to establish a mechanism for regularly publishing approved innovative drug and device lists and will support the application of these innovations [3] - Guangdong will focus on reforming medical institution preparations as a breakthrough in biopharmaceutical R&D, promoting collaboration between medical institutions and biopharmaceutical companies [3] Group 4: Strategic Planning - The "Three-Year Attack Plan for Key Areas of Advanced Equipment in Guangdong Province (2025-2027)" is being developed, focusing on artificial intelligence, biomanufacturing, marine engineering, and aerospace [4]

2025年2月8日，国家药品监督管理局批准了 杭州端佑医疗科技有限公司（ 臻亿医疗的全资子公司 ） "经导管二尖瓣夹系统" （ 国械注准20253130304 ）和 先 健科技（深圳）有限公司（ 1302.HK ）的"主动脉覆膜支架系统" （ 国械注准20253130305 ） 2个创新产品注册申请。我国上市的创新医疗器械 累计324项。 | 索引号 | XZXK-2025-128 | 主题分类 | | --- | --- | --- | | 标题 | 经导管二尖瓣夹系统获批上市 | | | 发布日期 | 2025-02-08 | | "经导管二尖瓣夹系统" （ 国械注准20253130304 ） 原文： 近日，国家药品监督管理局批准了 杭州端佑医疗科技有限公司"经导管二尖瓣夹系统"创新产品注册申请。 该产品适用于经心脏团队评估后认为存在外科手术高风险，且二尖瓣瓣膜解剖结构适合的退行性二尖瓣反流（MR≥3+）患者。产品采用包裹托举状的闭合形态设 计，预期可以实现植入后稳固的锚定；采用锚固件四通道控制通路设计，能够实现瓣叶同时或者分别捕获，预期提高手术成功率，减少手术风险。 思宇MedTech整理的产品和企业信 ...