“明瞳”获批上市 为国内首个获批的脑机接口Ⅲ类医疗器械

Core Insights - Nanjing Shanhai Medical Technology Co., Ltd. has received approval from the National Medical Products Administration for its brain-computer interface medical device "Mingtong," marking it as the first domestically approved Class III medical device in this category [1][2] - "Mingtong" serves as a high-end electrophysiological device used in functional neurosurgery, enabling real-time collection, localization, and modulation of deep brain signals during deep brain stimulation (DBS) surgeries [1][2] - The device is designed to replace imported products, providing precise identification of target areas and reducing risks associated with previous reliance on imaging techniques [2] Company Overview - Shanhai Medical is a national high-tech enterprise focused on solutions for brain diseases and brain science, with a comprehensive capability from technology development to clinical promotion [3] - The company collaborates with top medical institutions and universities to drive technology implementation and aims to establish a self-controlled digital diagnosis and treatment ecosystem for brain diseases [3] Product Features - "Mingtong" features multi-mode stimulation capabilities, allowing for personalized adjustments based on patient conditions, and collects patient data for clinical optimization [2] - The device incorporates advanced technologies to overcome challenges such as interference in hospital environments, ensuring safety and rapid signal recognition [2] - The development team has addressed unique medical device challenges, including electrode material selection and sterilization methods, through extensive testing [2]