摘要 【脑机接口专题】政策+创新双轮驱动，商业化落地进入快 车道 20250814 中国药监局政策支持加速脑机接口医疗器械上市，湖北和浙江等地率先 落地，优化全生命周期监管，明确产品注册标准，推动行业研发和商业 化加速发展。 脑机接口应用广泛，医疗领域针对多种疾病，非嵌入式产品用于睡眠、 情绪、游戏和智能家居。全球市场预计 2024 年达 26.2 亿美元，未来十 年医疗领域有望达 150 亿美元，消费医疗超 250 亿美元，总体超 400 亿美元。 侵入式脑机接口方面，Neuralink 和 Paradromics 领先，已进行人体 植入实验。国内企业集中于非侵入式产品研发，一级市场融资活跃，今 年上半年融资超 8 亿元。 脑机接口技术分非嵌入式、半嵌入式和嵌入式三类。侵入式信号质量高， 但风险大，主要用于瘫痪患者。非嵌入式和半嵌入式安全性高，在消费 领域有前景。 Q&A 国内近期密集出台的支持性政策对脑机接口行业有哪些深远影响？ 国内近期出台的支持性政策对脑机接口行业具有深远影响。首先，医保局在今 年 3 月份将侵入式脑接口植入、取出及适配费纳入神经系统类医疗服务价格项 目，并已在湖北和浙江等地率先落地， ...

Core Viewpoint - Neuralink, led by Elon Musk, aims to revolutionize human interaction with technology through brain-machine interfaces, enabling individuals to control devices with their thoughts and potentially enhancing human capabilities [1][11]. Group 1: Current Developments - Neuralink has successfully implanted devices in seven individuals, allowing them to interact with the physical world through thought, including playing video games and controlling robotic limbs [3][5]. - The company plans to enable blind individuals to regain sight by 2026, with aspirations for advanced visual capabilities akin to those seen in science fiction [5][12]. Group 2: Future Goals - Neuralink's ultimate goal is to create a full brain interface that connects human consciousness with AI, allowing for seamless communication and interaction [11][60]. - A three-year roadmap has been outlined, with milestones including speech decoding by 2025, visual restoration for blind participants by 2026, and the integration of multiple implants by 2028 [72][74][76]. Group 3: Technological Innovations - The second-generation surgical robot can now implant electrodes in just 1.5 seconds, significantly improving the efficiency of the procedure [77]. - The N1 implant is designed to enhance data transmission between the brain and external devices, potentially expanding human cognitive capabilities [80][81].