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国产医疗器械发展
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最新!7款医疗器械进入创新通道
思宇MedTech· 2025-11-28 09:40
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: ...
耗材集采步入深水区,再现“全进口”中标
Core Insights - The focus of medical consumables procurement has shifted from large-scale coverage to emphasizing product quality and clinical value, marking a new phase of "quality enhancement" in procurement [1][4] - In a recent procurement announcement, five foreign companies won bids for cerebrospinal fluid shunt systems, with no domestic companies selected, indicating a strong preference for imported products [1][3] Group 1: Procurement Results - The procurement results show that products from Medtronic, Integra, Christoph Miethke, Sophysa, and HPB from Brazil were selected, with prices remaining stable compared to previous bids [1][2] - The proposed prices for the selected products range from 2,349 to 26,100 yuan, reflecting a consistent pricing strategy among foreign brands [2][3] Group 2: Market Dynamics - Imported brands dominate the cerebrospinal fluid shunt market due to their established technology and higher clinical acceptance, while domestic products struggle to gain recognition [3][4] - The complexity of manufacturing these medical devices, particularly the valves, presents a significant barrier for domestic companies, which are still developing their technologies [3][4] Group 3: Future Opportunities for Domestic Companies - Despite the current dominance of foreign products, there is a pathway for newly approved domestic products to enter the market if they meet pricing requirements [6][7] - Domestic companies are actively innovating and closing the technology gap, with several firms developing new products and patents that could enhance their market position [6][7] Group 4: Industry Trends - The ongoing procurement process is expected to increase the clinical penetration of cerebrospinal fluid shunt systems, fostering greater market demand [6][7] - The advancement of technologies such as IoT and AI may lead to innovations in domestic products, potentially positioning them as leaders in the industry [7]
国产双端支架烟威地区首例手术成功
Qi Lu Wan Bao· 2025-06-12 21:06
Core Viewpoint - The successful placement of the first dual-end new type of thermally expanded nickel-titanium alloy stent in the Yantai region marks a significant advancement in medical technology, improving treatment for ureteral strictures and enhancing patient quality of life [1][2] Group 1: Medical Technology Advancement - The new nickel-titanium alloy stent effectively supports the narrowed ureteral area, reduces stone shell formation, and extends stent retention time while minimizing urinary tract irritation symptoms [1] - This stent is the first domestically produced ureteral stent that can be retained long-term, featuring a segmental design that precisely covers the narrowed area without affecting ureteral peristalsis [1] - The metal stent offers high support strength and is less prone to deformation, providing better internal drainage and structural assurance for long-term retention [1] Group 2: Economic and Quality of Life Benefits - The introduction of the domestic thermally expanded nickel-titanium alloy stent alleviates the financial burden on patients caused by high-priced imported stents, enhancing treatment outcomes and patient quality of life [1] - The metal ureteral stent system can be retained long-term, avoiding issues associated with frequent replacements, such as bladder irritation and poor drainage, thus lowering medical costs and increasing health economic value [1] - The stent's tight spiral structure provides strong radial support, reduces complications like bladder irritation and reflux, and is easy to install and remove, ensuring a safe and smooth surgical process [1]