迈瑞展区内人头攒动，启元大模型、瑞影、瑞检等系列产品正进行现场演示，工作人员讲解产品特性， 吸引了众多观众咨询交流；西门子医疗展区内，几台磁共振成像设备静静陈列，专业讲解员围绕设备的 临床应用场景、影像清晰度提升等核心优势展开介绍，让观众近距离感受高端医疗装备的科技魅力。 一批AI药械、手术机器人领域的产品引人关注。精锋医疗展示了其自主研发的多孔腔镜手术机器人、 单孔腔镜手术机器人、支气管镜手术机器人等丰富完整的产品组合，并为观众演示精细的手术画面。粒 影科技发布的AI+药械研发公共服务平台，深度融合"AI蛋白质结构预测与设计""AI底盘细胞改造"等多 项自研核心技术，可将传统需数年的研发周期缩短至数月。 药械产值1576亿元 12月18日，2025深圳国际高性能医疗器械展暨创新医药展在深圳会展中心举行。此次展会设置了医学影 像及放疗、医学检验、应急救治及康复、人工智能及机器人、创新医药、供应链等"8+1+1"十大展区， 吸引了300余家全球医药与医疗器械领域的领军企业和机构参展，展示千余件创新产品，涵盖高端医疗 器械、创新药、生物制造、AI+药械、消费医疗、核心零部件等深圳乃至国内药械领域的最新成果，为 医 ...

手术机器人是本届展会关注的焦点之一，其发展已从单点突破走向多术式、全流程覆盖。如今，手术机 器人不仅仅作为解决单一术式的"工具"，更演进为覆盖多科室、整合多模式的智能手术平台，引领着手 术领域的革命性变革。 展会现场，精锋医疗展示了其单孔/多孔腔镜手术机器人，系统凭借灵活的"内腕"器械与高清三维视 觉，使单一切口下的复杂手术成为可能，大幅降低患者创伤；元化智能带来的髋膝单髁三位一体手术机 器人，将关节置换手术的规划、导航与执行融为一体，实现了对髋、膝关节疾病的全覆盖精准治疗；罗 伯医疗则专注于消化内镜赛道，其一次性使用柔性机械臂与主机系统配合，实现了内镜手术的精准操控 与全程无菌，正改变着传统内镜诊疗模式。 除了手术室里的"机械臂"，展会上能"读懂"人体信号的脑机接口产品，也引得无数观众驻足，成为另一 大亮点。脑机接口技术正突破传统医疗边界，从功能替代延伸到健康增强与主动干预，成为引领智慧医 疗未来的关键驱动力。 手术刀被机械臂精准替代，影像设备拥有"超清透视"之力，脑机接口正学习"翻译"神经信号，抗肿瘤药 带来颠覆性"新解"、玩游戏协助关节康复训练……这些勾勒未来医疗的想象，正生动地铺陈在2025深圳 国际 ...

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]

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 ...