国内首次！阶梯医疗脑机接口进入审批“绿色通道” 2028年有望获批上市

Core Viewpoint - Shanghai Ladder Medical Technology Co., Ltd. has announced that its self-developed "Implantable Wireless Brain-Computer Interface System" has officially entered the special review procedure for innovative medical devices by the National Medical Products Administration, marking a significant step in the industrialization of brain-computer interface technology in China [1][2]. Group 1: Product Development and Approval - The implantable brain-computer interface is the first invasive product to enter the "green channel" in China, which allows for accelerated review and approval processes, reduced registration fees, and comprehensive support for innovation [1][2]. - The product integrates key technologies for neural signal acquisition, decoding, and control, enabling precise motor signal recognition, which opens new avenues for functional replacement for patients with motor disabilities [2][6]. - The product must meet three core conditions to enter the "green channel": compliance with intellectual property rights, a standardized research process, and outstanding technical and clinical value [3]. Group 2: Market Potential and Growth - The brain-computer interface industry is transitioning from laboratory research to clinical and commercial stages, with the Chinese market projected to reach 3.2 billion yuan in 2024, growing at a rate of 18.8%, and expected to reach 6.14 billion yuan by 2028, with a compound annual growth rate of 17.7% [7]. - The implementation of policies to promote the innovation and development of the brain-computer interface industry is expected to enhance the industry's innovation capabilities and establish a reliable industrial system by 2030 [7][8]. - The recent approval of the first industry standard for brain-computer interface medical devices in China aims to unify terminology and provide a foundation for research, registration, and regulation [8]. Group 3: Industry Challenges and Dynamics - Despite the promising outlook, the transition from clinical research to commercial viability for brain-computer interfaces faces challenges such as technology maturity verification, collaborative development across the industry chain, and market awareness cultivation [8][9]. - Recent fluctuations in A-share brain-computer interface concept stocks indicate market volatility, with companies experiencing significant price changes following news related to the industry [8].