近日， 国家药品监督管理局 （NMPA） 发布 《优先审批高端医疗器械目录（2025版）》 ，共有 8 类高端医疗器械 被纳入优先审批范围。与以往不同的是，这一目 录并非单纯的"技术清单"，而更像一次明确的监管表态： 在安全有效前提下，为真正处于关键窗口期的高端技术争取时间与确定性 。 从具体入选方向看，这 8 类产品横跨 肿瘤放疗、影像设备、介入治疗、手术机器人、神经调控与生命支持等 多个高复杂度赛道，既包含国内尚处空白的前沿技 术，也覆盖已有产品但仍存在明显临床或技术边界的成熟领域。 "优先审批"并不等同于降低标准，而是一种 监管资源配置方式的变化 。 在现行医疗器械注册体系下，高端创新器械往往面临技术复杂、临床验证周期长、注册沟通成本高等问题。通过设立高端医疗器械优先审批目录，监管部门释放出 的信号并非"放行"，而是： 在满足安全性和有效性要求的前提下，通过提前介入、并行审评和资源倾斜，压缩不必要的制度性时间成本 。 因此，目录本身并不是终点，而是一个 技术被纳入"重点审评视野"的起点 。 # 八类高端医疗 器械 概览 硼中子俘获治疗系统（BNCT） 该系统通过中子与硼药发生俘获反应，产生高杀伤力的次级 ...

Core Viewpoint - The article discusses the approval and significance of the Boron Neutron Capture Therapy (BNCT) system developed by Guoke Neutron Medical Technology Co., Ltd., highlighting its potential as a new cancer treatment method with advanced precision and lower side effects [1][3][20]. R&D Background - BNCT is recognized as the "fifth cancer treatment method" after surgery, traditional radiotherapy, chemotherapy, and immunotherapy, particularly effective for hard-to-treat cancers like glioblastoma, head and neck cancer, and melanoma [2]. - The global BNCT market is estimated to be several hundred million dollars in 2023, with a projected CAGR of 10%-15% by 2030, primarily in Japan, the USA, and Europe [2]. - Japan's Sumitomo Heavy Industries and Stella Pharma launched the first BNCT device and boron drug in 2020, with treatment costs around tens of thousands of dollars per session [2]. About the BNCT System - The BNCT system developed by Guoke Neutron Medical Technology utilizes neutron and boron reactions to precisely kill tumor cells, marking the success of China's first self-owned intellectual property BNCT device [3][20]. - The device consists of a Radio Frequency Quadrupole (RFQ) accelerator, neutron generation system, and treatment room, designed to treat cancers that are difficult to manage with conventional methods [5]. Technical Analysis of BNCT - BNCT employs a two-pronged approach combining radiation and drug therapy, specifically targeting infiltrative and metastatic cancers [6]. - The treatment involves injecting boron-containing drugs that accumulate in tumor cells, followed by neutron irradiation, which leads to a nuclear reaction that effectively destroys cancer cells while sparing healthy tissue [9][13]. Advantages of BNCT - BNCT requires only 1-2 treatment sessions compared to over 30 sessions for conventional therapies, significantly reducing treatment duration [10][13]. - The treatment's precision is enhanced by the biological targeting of boron drugs, minimizing damage to surrounding healthy tissues [13]. Product Development History - The development of BNCT in China began in 2006 under the "973" program, with significant milestones achieved over the years, including the establishment of the first domestic RFQ accelerator and the successful installation of the first clinical BNCT device in Dongguan [14][15]. Company Overview - Guoke Neutron Medical Technology Co., Ltd. was established in 2021, focusing on the R&D, production, and marketing of high-end medical equipment for BNCT [20]. - The company has successfully completed clinical device design and testing, with high operational efficiency reported for its installed BNCT equipment [17][19].