磁共振监测半导体激光治疗设备
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最新!又3款创新器械获批上市!
思宇MedTech· 2025-10-30 04:20
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、一次性使用激光光纤套件和立体定向手术计划软件创新产品获批上市
Ren Min Wang· 2025-10-29 02:41
Core Viewpoint - The National Medical Products Administration has approved three innovative products from Hangzhou Jialiang Medical Technology Co., Ltd., including a magnetic resonance monitoring semiconductor laser treatment device, a disposable laser fiber kit, and a stereotactic surgical planning software [1] Group 1: Product Details - The magnetic resonance monitoring semiconductor laser treatment device consists of a main unit and accessories [1] - The disposable laser fiber kit includes a medical fiber catheter component and a cooling water pipe [1] - The stereotactic surgical planning software is composed of a USB drive and a key [1] Group 2: Application and Benefits - The magnetic resonance monitoring semiconductor laser treatment device and the disposable laser fiber kit are designed for laser treatment of drug-resistant epilepsy patients with focal seizures and clear epileptogenic zones [1] - The stereotactic surgical planning software is used in conjunction with the laser treatment device for planning head stereotactic surgeries [1] - The products aim to minimize damage to normal brain tissue during surgery, thereby better preserving cognitive function [1] Group 3: Regulatory Oversight - The drug supervision authority will enhance post-market supervision of the approved products to ensure patient safety [1]