国产侵入式脑机接口进入审评“绿色通道” 资本竞逐前沿医疗蓝海

Core Insights - Shanghai Ladder Medical Technology Co., Ltd.'s "Implantable Wireless Brain-Computer Interface System" has entered the special review process of the National Medical Products Administration (NMPA), marking a significant step in the commercialization of invasive brain-computer interface products in China [1] Group 1: Industry Breakthroughs - The invasive brain-computer interface (BCI) technology is seen as a revolutionary method for human-computer interaction, with invasive products offering more precise signal transmission due to direct implantation into the brain cortex [2] - The implementation of the "green channel" significantly shortens the product review cycle from 3-5 years to an expected 1-2 years, which is crucial for rapidly evolving technologies [2] Group 2: Industry Chain Development - China's BCI industry chain has been continuously improving, with a complete chain covering upstream materials, chips, electrodes, midstream signal collection and processing, and downstream medical health and consumer markets [3] - Progress in upstream areas, such as biocompatible materials and low-power chips, supports performance improvements in midstream and downstream products, with clear commercialization paths in the medical field [3] Group 3: Market Growth and Investment - The global BCI market in medical applications is projected to reach $40 billion by 2030 and exceed $145 billion by 2040 [3] - In China, the BCI market is expected to reach 3.203 billion yuan in 2024, with a year-on-year growth of 18.81%, and is forecasted to reach 3.830 billion yuan in 2025 [3] Group 4: Capital Market Dynamics - The BCI industry has seen an annualized financing growth rate of over 30% from 2018 to 2024, with 20 new financing events in just the third quarter of 2025 [4] - Continuous capital influx is expected to accelerate technology transformation and industry consolidation, with the industry still in its early stages and exploring technical routes and business models [4] Group 5: Clinical Applications and Challenges - Clinical trials, such as those conducted by Fujian Sanbo Neurosurgery Hospital, have successfully demonstrated the feasibility of domestic technology in clinical settings [4] - There is a need for a mature standard system for long-term biocompatibility and signal stability assessments, which is a core issue that needs to be addressed in the BCI field [5]