国内首次，侵入式脑机产品进审批“绿色通道”

Core Insights - The article highlights the significant potential of new materials and flexible electrodes in China, particularly in the field of brain-computer interfaces (BCIs) [1][7] - The approval of the first invasive brain-computer interface product by Shanghai Ladder Medical Technology Co., Ltd. marks a milestone in the domestic medical device industry [1][4] Industry Overview - The innovative medical device special review procedure established by the National Medical Products Administration (NMPA) aims to encourage innovation in medical devices, providing expedited review for products with core technology patents and significant clinical value [2][3] - The invasive brain-computer interface technology requires surgical implantation, which presents higher technical barriers and risks but offers higher quality and precision in neural signal acquisition compared to non-invasive methods [3][4] Company Developments - Shanghai Ladder Medical, founded in 2021, focuses on the development of implantable brain-computer interface technology and has recently completed a 350 million yuan Series B financing round [3][4] - The company's ultra-flexible electrode technology allows for minimally invasive implantation, significantly reducing the risk of tissue damage and immune response [4][6] Clinical Progress - Ladder Medical has initiated clinical trials, with a recent case demonstrating a participant controlling a computer cursor using thought after undergoing the brain-computer interface implantation [6][8] - The company is now the second globally, after Neuralink, to enter the clinical phase of invasive brain-computer interfaces [6][8] Market Potential - The global brain-computer interface market is projected to grow from approximately $2.62 billion in 2024 to $12.4 billion by 2034, with a compound annual growth rate of 17.35% [8] - The Chinese brain-computer interface market is expected to expand from 3.2 billion yuan in 2024 to 6.14 billion yuan by 2028, indicating strong growth potential in the sector [8] Regulatory Environment - Recent policy developments, including the establishment of industry standards for brain-computer interface medical devices, are expected to facilitate faster market entry for approved products [7][8] - The NMPA's new standards for brain-computer interface terminology will take effect on January 1, 2026, marking a significant step in regulatory clarity for the industry [7][8]