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），宣布来自 深圳大 医伽玛刀科技有限公司 的 头部伽玛射线立体定向放射外科治疗系统 进入创新通道。 在技术层面，CybeRay 采用多束 钴-60 γ射线 ，通过几何聚焦实现高剂量精准照射，靶点定位精度达到 亚毫米 级（<0.5mm） 。系统搭载锥形束 CT（CBCT）或其他实时影像技术，能够在治疗过程中动态校正靶区位置， 显著减少因患者微小运动带来的治疗偏差。此外，其治疗规划软件集成了 AI 优化算法，可在短时间内制定个 体化剂量分布，提升治疗效率。 临床数据显示，CybeRay 的单次治疗时间通常在 30-60 分钟之间，治疗过程无创、无痛，患者无需开颅或住院 长时间观察，术后并发症发生率极低（<0.5%）。2023年，大连大学附属中山医院等国内多家医院已投入 CybeRay 使用，报道显示，患者五年生存率相比传统放疗提升 10-15%，术后恢复时间缩短约 30%。 在市场竞争层面，CybeRay 相较瑞典医科达 Leksell Gamma Knife，不仅在价格上更具优势（约低 30-40%）， 也凭借头体两用和实 ...

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].