硼中子俘获治疗系统、植入式脑机接口在列！2025版优先审批高端医疗器械目录出炉
Zhong Guo Jing Ji Wang·2025-12-31 04:10

Core Viewpoint - The National Medical Products Administration (NMPA) of China has released the "Priority Approval Catalog for High-end Medical Devices (2025 Edition)", which includes eight advanced medical devices for expedited approval, aiming to accelerate the market entry of innovative high-end medical equipment [1]. Group 1: Priority Approval Catalog - The catalog includes advanced medical devices such as the boron neutron capture therapy system, ultra-high field magnetic resonance imaging equipment, medical electron accelerators, and implantable brain-machine interface devices [1][2]. - The NMPA will implement priority approval for the medical devices listed in the catalog according to Article 73, Item 3 of the "Regulations on the Registration and Filing of Medical Devices" [1][5]. Group 2: Device Specifications - The boron neutron capture therapy system is designed to treat malignant tumors that are recurrent or for which there are no other conventional treatment options, utilizing a reaction between neutrons and boron to produce secondary particles that kill cancer cells [2]. - The ultra-high field magnetic resonance imaging equipment has a magnetic field strength greater than 5 Tesla [2]. - The medical electron accelerator integrates magnetic resonance imaging guidance and is used for various therapeutic applications [2]. - The implantable brain-machine interface device captures neural signals from the central nervous system through implanted electrodes, enabling interaction with external control devices for compensating motor and sensory dysfunctions [2]. - The endoscopic surgical control system employs robotic technology for operating surgical instruments through natural orifices [2]. - The transcatheter tricuspid valve repair system is suitable for high-risk patients with severe tricuspid regurgitation who are deemed unsuitable for surgical intervention [2]. - The minimally invasive glaucoma surgery (MIGS) implant establishes a drainage pathway for aqueous humor in the eye [2].