Core Viewpoint - The recent approval of two medical device industry standards by the National Medical Products Administration (NMPA) marks a significant step towards the high-quality development of brain-computer interface (BCI) technologies in the medical field, providing essential support for standardization and regulation [1][2]. Group 1: Standardization and Development - The two newly established standards focus on the design and application of BCIs for medical devices, specifically addressing issues related to motor function rehabilitation and the reliability of invasive devices [7]. - The BCI market in China is projected to reach 3.2 billion yuan in 2024, with an 18.8% year-on-year growth, and is expected to grow to 5.58 billion yuan by 2027, reflecting a 20% growth rate [6]. - The establishment of these standards is a response to the challenges faced by the BCI industry, including terminology confusion, fragmented technology layout, and lack of unified regulations, which have hindered rapid development [6][7]. Group 2: Policy and Industry Resonance - Recent policies have positioned BCIs as a key future industry, with the 14th Five-Year Plan highlighting their potential as a new engine for economic growth [9]. - The NMPA has prioritized the approval of implantable BCI medical devices, expediting the market entry of innovative products [9]. - The commercial process for BCIs is expected to accelerate, with significant policy support and technological advancements driving rapid industry growth [10]. Group 3: Future Development and Market Dynamics - The future vision for the BCI industry includes cultivating globally influential leading enterprises and a number of specialized small and medium-sized enterprises by 2030 [11]. - Potential applications in the medical field are expected to expand beyond mere functional restoration to include "functional enhancement" applications, utilizing a combination of multiple devices and technologies [11].

21世纪经济报道记者闫硕 脑机接口标准化建设传来新消息。 近日，国家药监局批准《采用脑机接口技术的医疗器械范式设计与应用规范运动功能重建》《采用脑机接口技术的医疗器械侵入式设备可靠性 验证方法》等2项医疗器械行业标准制修订项目立项，为采用脑机接口技术的医疗器械高质量发展提供标准支撑。 脑机接口是一种在脑与外部设备之间建立直接的通信渠道。常用于辅助、增强、修复人体的感觉–运动功能或提升人机交互能力，目前在医学 领域应用较为广泛。根据植入条件，脑机接口可分为侵入式、非侵入式和半侵入式三种。 近年来，随着神经信号处理、生物兼容材料、高性能芯片等一系列核心技术接连突破，脑机接口得以快速发展。与此同时，相关支持政策不断 落地，标准化建设成为规范行业发展、保障产品安全有效的关键抓手。 健康通副总裁、首席发展官张畅向21世纪经济报道记者表示，此次2项标准的立项是对工信部等七部门此前发布的《关于推动脑机接口产业创 新发展的实施意见》（简称《实施意见》）中标准体系建设相关内容的具体落实，同时也结合行业反馈的共性难题实现了空白填补。由此，也 为医疗领域开展相关研究、临床试验等后续"专业步骤"，迈出了有章可循的关键第一步。 强化标 ...

让瘫痪患者用"意念"控制电脑光标、轮椅、机器狗……过去一年来，我国脑机接口技术迈入植入人脑的 新阶段，密集涌现出一批突破性进展。 "意念"控制电脑光标、轮椅 2025年12月，中国科学院脑科学与智能技术卓越创新中心联合复旦大学附属华山医院等单位，发布了脑 机接口临床试验的新进展：一位因颈髓损伤而四肢瘫痪的患者，仅凭"意念"控制，即可坐着电动轮椅在 小区里遛弯，也能指挥机器狗取外卖。 "这是我们的第二例前瞻性临床试验。之后的第三例前瞻性临床试验进一步拓展了脑机接口的功能，患 者能控制机械臂完成喝水、进食等动作。"中国科学院脑科学与智能技术卓越创新中心研究员赵郑拓 说。 此前，该团队在2025年6月发布第一例前瞻性临床试验，在脑机接口的帮助下，一位因高压电事故四肢 截肢的患者实现了"意念"控制电脑光标。 记者采访了解到，对于需要植入人脑的脑机接口医疗器械，有的需要穿透硬脑膜，直接接触或插入大脑 皮层，有的仅放置在硬脑膜外，也称为半侵入式。相比而言，前者能实现的功能更强，但技术和安全性 要求更高，后者的研究和应用进展则更快。 作为"十五五"规划建议锚定的六大未来产业之一，脑机接口技术旨在通过在脑与机器之间建立信息通 ...

新华社北京1月27日电 题：植入人脑之后，脑机接口技术将如何改变我们的生活？ 此前，该团队在2025年6月发布第一例前瞻性临床试验，在脑机接口的帮助下，一位因高压电事故四肢 截肢的患者实现了"意念"控制电脑光标。 记者采访了解到，对于需要植入人脑的脑机接口医疗器械，有的需要穿透硬脑膜，直接接触或插入大脑 皮层，有的仅放置在硬脑膜外，也称为半侵入式。相比而言，前者能实现的功能更强，但技术和安全性 要求更高，后者的研究和应用进展则更快。 例如，2025年12月，一家脑机接口团队在上海举办的2025脑机接口大会上宣布，半侵入式脑机接口多中 心注册临床试验取得显著成果。试验历时78天，32位颈部脊髓受损患者在十余家医院接受脑机接口植入 手术，受试者能够凭"意念"控制气动手套，完成抓握等精细动作。 上海市医疗器械检验研究院有源器械检验一所副所长胡晟介绍，从功能上看，业界正在研发的侵入式脑 机接口主要聚焦在运动、语言等能力替代，精细神经调控以及视觉等感知觉重建领域。 新华社"新华视点"记者董雪 让瘫痪患者用"意念"控制电脑光标、轮椅、机器狗……过去一年来，我国脑机接口技术迈入植入人脑的 新阶段，密集涌现出一批突破性进展。 ...

截至2026年1月21日 13:11，中证医药及医疗器械创新指数(931484)上涨0.03%，成分股特宝生物上涨 3.38%，甘李药业上涨2.24%，英科医疗上涨1.70%，康龙化成上涨1.23%，大博医疗上涨1.16%。医疗创 新ETF(516820)多空胶着，最新报价0.37元。 医疗创新ETF紧密跟踪中证医药及医疗器械创新指数，中证医药及医疗器械创新指数从医药卫生行业的 上市公司中，选取30只盈利能力较好且具备一定成长性和研发创新能力的上市公司证券作为指数样本， 以反映兼具盈利性与成长性的医药及医疗器械上市公司证券的整体表现。 数据显示，截至2025年12月31日，中证医药及医疗器械创新指数(931484)前十大权重股分别为药明康 德、恒瑞医药、迈瑞医疗、爱尔眼科、片仔癀、新和成、华东医药、康龙化成、艾力斯、甘李药业，前 十大权重股合计占比63.75%。 风险提示：基金有风险，投资需谨慎。基金管理人承诺以诚实信用、勤勉尽责的原则管理和运用基金资 产，但不保证本基金一定盈利，也不保证最低收益。基金管理人提醒投资人基金投资的"买者自负"原 则，在做出投资决策后，基金运营状况与基金净值变化引致的投资风险，由 ...

1月18日，据武汉经开区消息，武汉协和医院智能脑机接口研究院将落户车谷院区。据悉，智能脑机接 口研究院将致力于侵入式和非侵入式脑机接口关键核心技术研究，建成国内首个脑机接口专病智能体矩 阵，构建百万级多模态脑病数据库，完成多项脑机接口医疗器械临床试验，孵化培育一批掌握核心技 术、具有市场竞争力的脑机接口科技型企业。 ...

Market Overview - On December 22, 2025, the market closed higher with a trading volume of 1.75 trillion, an increase of approximately 70 billion from the previous trading day[1] - The majority of industries saw gains, particularly commerce, light industry, environmental protection, and social services, while a few sectors like banking, coal, and electronics experienced slight declines[1] - The Shanghai Composite Index showed a three-day upward trend, indicating some technical recovery, although the Sci-Tech Innovation Board remains in a weaker technical state[1] Industry Trends - Recently active sectors such as cyclical and consumer industries have shown increased activity, contrasting with the historically dominant technology sector[1] - The commercial aerospace sector remains strong but has shown signs of slowing momentum, with notable stock differentiation within the sector[1] - Valuations in the non-ferrous metals and insurance sectors are worth further attention, while the autonomous driving sector has seen a recent accumulation of events[1] Fund Flow - On December 19, the net inflow for the Shanghai Stock Exchange was 24.489 billion, while the Shenzhen Stock Exchange saw a net outflow of 8.336 billion[4] - The top three sectors for net inflow were automotive parts, general equipment, and general retail, while the semiconductor and electronic components sectors faced the largest outflows[4] Economic Indicators - From January to November 2025, the national online retail sales increased by 9.1%, with smart wearables and smart robots growing by 22.1% and 19.4%, respectively[11] - The national railway transported 3.727 billion tons of goods from January to November, reflecting a year-on-year growth of 2.7%[12] Investment Activity - In December, the stock private equity positions reached a new high for the year, with the stock private equity position index rising to 83.59%, marking a 0.61 percentage point increase from the previous week[13] - Public fund institutions participated in 85 individual stock placements this year, with a total allocation exceeding 34.088 billion, a 14.24% increase from the same period last year[15]

人民财讯12月2日电，江西省人民政府办公厅印发《江西省加快脑机接口技术和产业发展若干措施》， 其中提出，加强创新产品推广。支持脑机接口医疗器械纳入创新产品推荐目录。支持符合条件的脑机接 口项目申报省工业发展专项，加快脑机接口整机产品迭代应用和规模化推广。遴选脑机接口创新应用项 目，定期发布创新应用典型案例和创新成果，推动开放应用场景。积极推进"人工智能+"行动，推动人 工智能技术加速脑机接口研发。依托省科技成果转移转化中心，组织脑机接口科技成果对接活动，加快 创新成果落地。支持牵头制修订相关标准的单位或个人申报"江西省省长质量奖和专利奖"标准项目奖和 个人奖。 ...

Core Viewpoint - Wuhan East Lake High-tech Zone is accelerating the development of the brain-computer interface (BCI) industry through a series of supportive measures aimed at fostering innovation and application in this field [1][2] Group 1: Policy Measures - The document titled "Several Measures to Support the Innovation and Development of the Brain-Computer Interface Industry" outlines policies to strengthen technological product development, promote the application of technological achievements, and build an innovative ecosystem [1] - Support is provided for enterprises in the BCI field to collaborate with universities, research institutions, and medical organizations to develop major BCI products in areas such as motion control, speech synthesis, treatment of neurological diseases, and visual reconstruction [1] - The measures include the establishment of experimental service platforms and shared equipment platforms for BCI products, as well as support for the first trials and applications of BCI products [1] Group 2: Industry Development Initiatives - The "Five Ones" implementation path for advancing the BCI industry includes forming an industry alliance, building a specialized park, issuing a special policy, releasing application scenarios, and establishing an industry fund [2] - The Hubei BCI Industry Innovation Development Alliance has been established in East Lake High-tech Zone, and efforts are underway to create a BCI industry cluster area [2] - The International Brain-Computer Interface Innovation Center, a key innovation driver, is being constructed in collaboration with Tongji Hospital and Union Hospital, aiming to provide a comprehensive service system from concept validation to clinical trials and industrial transformation [2]

Core Viewpoint - The National Medical Products Administration (NMPA) has approved the implementation of the first industry standard for brain-computer interface (BCI) medical devices in China, set to take effect on January 1, 2024, positioning China as a leader in this field internationally [1][6]. Summary by Relevant Categories Definition and Scope of BCI - The new standard defines "brain-computer interface" as a medical device capable of real-time decoding neural signals from the central nervous system, facilitating bidirectional information exchange between patients and external devices to improve or replace certain physiological functions [1][3][5]. Standardization and Regulatory Support - The standard provides a unified language for product development, production inspection, registration review, and regulation, covering core terms related to BCI medical devices, including paradigm types, signal forms, and signal processing [3]. - NMPA is expediting the establishment of multiple related standards and supportive policies to foster rapid development in the BCI medical device industry, with three additional standards already in the pipeline [9][11]. Market Growth and Future Projections - The BCI market in China is projected to exceed 6 billion yuan by 2028, with an estimated compound annual growth rate (CAGR) of 17.7% from 2024 to 2028. The global market for BCI applications in healthcare is expected to reach $40 billion by 2030 and $145 billion by 2040 [12].