招商通知 第三届全球手术机器人大会 第二届全球医疗科技大会 2025年7月2日，NMPA公布了创新医疗器械特别审查申请审查结果公示（2025年第6号），有 14款产品 进入创新通道。其中包括， 北京尚宁科智医疗器械有限公司 申请的 可降解锌合金界面螺钉 。 # 研发背景 锌 作为人体必需微量元素，具有适中的降解速率和良好的生物相容性，是继镁基和铁基材料之后的新一代可 降解医用金属材料。相比其他材料， 锌合金的降解速率（约20 μm/a）接近理想的生物可吸收材料基准 ，能 够在组织修复后逐步降解代谢，避免长期植入可能引发的并发症。 研究表明， 锌合金的降解产物（如Zn²⁺）在体内浓度远低于毒性阈值 ，且对血液和细胞的相容性良好， 溶 血率低于5%，符合ISO标准 。 通过添加镁、铜、锰、锆等元素，锌合金克服了纯锌机械性能较差的缺点， 显著提高了强度、耐蚀性和细胞相容性 。 锌合金在降解过程中释放的锌离子可促进骨生长和软组织修复，适 用于骨科和运动医学领域。 由于锌合金的可塑性强，可以加工成棒、箔、板、丝、微管、多孔结构等，因此在临床上有着广泛用途， 全 球锌合金材料于2013年开始首次在医用领域进行尝试 。 尚 ...

Core Viewpoint - The article highlights the advancements in the medical technology sector, particularly focusing on innovative medical devices that have received special review status from the NMPA, indicating a growing trend in the industry towards innovation and regulatory support [1]. Company Summaries - Shenzhen Mindray Bio-Medical Electronics Co., Ltd. is a leading global medical device supplier, established in 1991, with a revenue of 36.73 billion yuan in 2024, reflecting a 5.1% year-on-year growth, and a net profit of 11.67 billion yuan, up 0.7% [5]. - Wuxi Reiming Vision Technology Co., Ltd. specializes in the research and production of artificial lenses, having developed advanced hydrophobic acrylic materials and received CE certification for its products, indicating its strong R&D capabilities [6]. - Shenzhen Gamma Knife Technology Co., Ltd. has been focused on high-end medical equipment, particularly in radiation therapy, since its establishment in 1993, showcasing its commitment to innovation in the medical technology field [7]. - Suzhou Puno Medical Technology Co., Ltd. is a national high-tech enterprise founded in 2020, dedicated to the development of products related to tumor brachytherapy, emphasizing its strong R&D capabilities and innovative approach [10]. - Hangzhou Aijinglun Technology Co., Ltd. is an innovative ophthalmic medical device company established in 2015, known for its unique suspension-type intraocular lens, which fills a gap in the market for high-degree correction lenses [13]. - Beijing Shanning Kezhi Medical Device Co., Ltd. focuses on biodegradable zinc alloy technology, with products entering clinical trials, showcasing its innovative approach in the biomedical field [15]. - Medtronic, a global leader in medical technology founded in 1949, operates in over 70 disease areas, providing lifelong treatment solutions for chronic disease patients [18]. - Shanghai Yangshan Biotechnology Co., Ltd. was established in 2023, collaborating with top hospitals and dental clinics, indicating its strong market positioning in the dental sector [19]. - Xiamen Shide Medical Equipment Co., Ltd. emphasizes innovation in surgical instruments, having obtained numerous patents and certifications, and is recognized for its diverse product line [20][21]. - Guangzhou Xinhanglu Medical Technology Co., Ltd. focuses on innovative cardiac electrophysiology products, with a unique four-dimensional mapping system that enhances treatment precision [22]. - Shanghai Jinkui Medical Device Co., Ltd. specializes in cardiovascular interventional materials, having developed several pioneering products and maintaining strong R&D partnerships [23]. - Guokexin Medical Technology Co., Ltd. is engaged in the development of advanced medical equipment for boron neutron capture therapy, marking a significant advancement in cancer treatment technology [24]. - Shanghai Ruining Biotechnology Co., Ltd. focuses on high-end biomedical materials, with a strong emphasis on innovation and collaboration with leading cancer treatment centers [25]. - Suzhou Sainasi Medical Technology Co., Ltd. is dedicated to cardiac electrophysiology, providing innovative solutions and a comprehensive product line for the medical field [26].