国产高端医疗器械创新
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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].
远程手术跨越洲际,单孔手术机器人展现中国创新
Bei Jing Ri Bao Ke Hu Duan· 2025-04-25 14:23
Core Viewpoint - The successful remote surgery performed by a Chinese team using a self-developed single-port robotic surgical system marks a significant milestone in the global medical field, showcasing China's innovation in high-end medical devices [1][2]. Company and Industry Summary - The single-port robotic surgical system, known as the snake-arm robot, is the world's first of its kind and was developed by a team led by Professor Xu Kai from Shanghai Jiao Tong University, who has over 20 years of research experience in this area [6]. - The snake-arm robot operates through a single 25mm port, featuring four flexible arms, including one for imaging, allowing for complex surgical procedures with minimal invasiveness [2][4]. - The technology has already been applied in various surgical fields, including urology, gynecology, and more complex surgeries such as total gastrectomy and lung segment resection, with over a thousand surgeries completed across dozens of hospitals [7]. - The company has plans to expand into the European market, anticipating approval for CE certification, which would facilitate its entry into this competitive landscape [7]. - The rise of domestic high-end medical devices in China is evident, with the country becoming the second-largest market for surgical robots globally, and local brands accounting for 81.7% of the approved products [8].