本报（chinatimes.net.cn）记者郭怡琳 于娜 北京报道 2025年9月15日，国家药品监督管理局最新批准发布了《采用脑机接口技术的医疗器械术语》医疗器械 行业标准。该标准明确界定了采用脑机接口技术的医疗器械相关术语与定义，将于2026年1月1日正式实 施。 据悉，该标准通过系统性构建脑机接口医疗器械的术语体系，明确基本概念、范式类型、信号形态、信 号处理及应用等核心术语及定义，为产业高质量发展奠定基础。对此，北京和君咨询有限公司合伙人史 万奎接受《华夏时报》记者采访时表示，"国家药监局通过快速程序推动该标准立项和制定，体现了对 新兴技术领域标准建设的重视程度，旨在破解行业术语不统一、概念不规范等困扰行业发展的基础性难 题。这项标准不仅提供了权威、统一的通用语言，也为脑机接口医疗器械研发生产和科学监管提供了关 键技术依据。" 政策框架日趋完善 产业集群初步形成 2023—2025年，全球脑机接口（BCI）临床试验进入爆发期，脑机接口技术从实验室加速迈向临床。 2024年，Neuralink首例人类患者实现意念操控电子棋盘的案例登上《细胞》封面引发舆论轰动。在此背 景下，中国"脑计划"推动天坛医院、 ...

Core Viewpoint - The article discusses the collaborative efforts of various Chinese financial institutions, particularly China Life, to support the innovation and development of the brain-computer interface (BCI) industry, highlighting significant investments and advancements in technology [1][2][5]. Group 1: Policy and Financial Support - The Ministry of Industry and Information Technology and six other departments issued implementation opinions to promote the innovation of the BCI industry [1]. - China Life has actively responded to this policy by integrating financial resources with technological innovation, aiming to accelerate the development of BCI technologies [1][2]. - As of June 2025, China Life's investment in technology self-reliance has exceeded 40 billion yuan, with over 20 projects funded in various advanced fields [2][5]. Group 2: Technological Advancements - A significant breakthrough in BCI was achieved with a clinical trial using high-throughput flexible electrodes developed by Beijing Zhirun Medical Technology Co., which allows for minimal damage during implantation and precise monitoring of neural signals [2][3]. - The BCI technology is being applied in medical, rehabilitation, and nursing fields, enabling patients to perform actions through thought, thus enhancing rehabilitation training [3][4]. Group 3: Investment in Emerging Companies - China Life's dual-carbon fund participated in a recent A-round financing for Zhirun Medical, raising over 300 million yuan to support the development of next-generation invasive flexible BCIs [2]. - Guangfa Bank, a member of China Life Group, provided tailored financial services to Lizi Intelligent Technology, offering a credit intention of 170 million yuan to support its application for national industry funds [4]. - The China Life Health Investment Fund has invested in over 60 projects, focusing on high-tech companies that address critical technological challenges [6].

Group 1 - The core viewpoint of the article highlights the significant funding round completed by Zhiran Medical, raising over 300 million yuan, bringing the total financing to nearly 500 million yuan since its establishment in 2022 [2] - The funding will primarily be used for core technology research and large-scale clinical trials, indicating a strong focus on advancing their invasive brain-machine interface technology [2][8] - Zhiran Medical's approach aligns with high-difficulty invasive solutions, utilizing ultra-thin flexible electrodes, which are considered crucial for efficient human-machine interaction [3][5] Group 2 - The company has developed a high-throughput flexible electrode that has received patent authorization in China and the U.S., designed to minimize implantation damage and enhance long-term signal stability [5][7] - A fully implanted high-throughput wireless signal acquisition system has been self-developed, capable of collecting action potentials from 1024 channels, which is complemented by deep neural network algorithms for precise intent decoding [7] - The establishment of a clinical-grade micro-nano processing workshop and GMP workshop allows for a fully controllable process from research and design to mass production, ensuring industrialization for future medical applications [7] Group 3 - The investment community views the invasive brain-machine interface as transitioning from laboratory research to clinical application, with breakthroughs in core technology and systematic implementation being key competitive indicators [8] - The Chinese government has issued policies encouraging the development of high-performance brain signal sensing components and surgical robots, providing a supportive environment for industry growth [8] - The combined effect of technology, capital, and policy is accelerating the clinical and industrialization processes of invasive brain-machine interfaces, making the performance of Zhiran Medical and similar companies a focal point for ongoing observation [8]