Core Viewpoint - The approval of three innovative products by Hangzhou Jialiang Medical Technology Co., Ltd. marks a significant breakthrough in domestic MRI-guided neurosurgical minimally invasive treatment equipment, enhancing treatment options for drug-resistant epilepsy patients [2][5][18]. Product Approval Information - On October 29, 2025, the National Medical Products Administration approved three innovative products: "MRI Monitoring Semiconductor Laser Treatment Device," "Disposable Laser Fiber Kit," and "Stereotactic Surgery Planning Software" [2][3]. - The total number of innovative medical devices approved in China has reached 377 [2]. Product Composition and Functionality - The MRI Monitoring Semiconductor Laser Treatment Device consists of a main unit and accessories, while the Disposable Laser Fiber Kit includes a medical fiber catheter component and a cooling water pipe. The Stereotactic Surgery Planning Software comprises an installation USB drive and a key [4][13]. - These products are designed for laser ablation treatment of focal lesions in drug-resistant epilepsy patients, utilizing MRI imaging for precise monitoring during surgery, thereby minimizing damage to normal brain tissue and preserving cognitive function [4][11]. Company Overview - Hangzhou Jialiang Medical Technology Co., Ltd. was established in 2020 and focuses on the industrialization of cutting-edge technologies in brain science and neurosurgery. The company has developed three major technology platforms: brain-machine control, medical lasers, and brain-machine chips [8]. - The company has established dual headquarters in China and Singapore, with a GMP production base and a professional R&D center, promoting independent innovation and global application of high-end neurosurgical systems [8]. Core Product Layout - The LaserRO™ MRI-guided laser ablation minimally invasive surgical system is a key component of the company's offerings, combining real-time MRI monitoring with laser fiber technology for targeted ablation of diseased tissue [9][11]. - The system is designed to provide a new treatment option for drug-resistant epilepsy patients, significantly reducing damage to normal brain tissue and enhancing cognitive function preservation [11][18]. Conclusion - The approval of these three innovative products opens a new technological dimension for domestic neurosurgical equipment, integrating real-time MRI monitoring, precise energy delivery, and surgical path planning, thus enhancing the treatment of complex brain diseases [18]. - This innovation not only fills technological gaps in individual products but also establishes a clinical system that integrates imaging, energy, and algorithms, positioning brain science as a new growth driver for domestic high-end medical device innovation [18].

磁共振监测半导体激光治疗设备由主机和配件组成。一次性使用激光光纤套件由医用光纤导管组件 和冷却水管组成。立体定向手术计划软件由安装U盘、密钥组成。磁共振监测半导体激光治疗设备与一 次性使用激光光纤套件配合，用于对药物难治性癫痫患者（局灶性发作，有明确的致痫区部位或明确的 癫痫传导途径）的局部病灶进行激光治疗。立体定向手术计划软件与磁共振监测半导体激光治疗设备配 合，用于头部立体定向手术计划制定。 药品监督管理部门将加强上述产品上市后监管，保护患者用械安全。 人民网北京10月29日电 （记者孙红丽）据国家药品监督管理局网站消息，近日，国家药品监督管 理局批准了杭州佳量医疗科技有限公司的磁共振监测半导体激光治疗设备、一次性使用激光光纤套件和 立体定向手术计划软件3个创新产品注册申请。 该产品可最大程度减少手术通路对正常脑组织的损伤，能更好保留认知功能。 ...