小米，布局脑机接口

器械之家2025-12-22

器械之家医疗器械媒体报道先锋分享专业医疗器械知识关注来源：器械之家，未经授权不得转载，且24小时后方可转载近日，小米宣布与脑虎科技、阶梯医疗两大脑机接口领军企业达成早期合作，计划将两类侵入式脑机技术接入米家生态。分析认为，这并非简单的技术嫁接，而是小米作为消费科技巨头对医疗领域的战略性布局：脑虎科技以“三全” 植入方案解决长期使用痛点，阶梯医疗以微创技术验证临床实用性，小米则以亿级智能设备生态打通...

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的落地闭环。资料显示，脑虎科技与阶梯医疗两家企业虽同属医疗级研发阵营，但在技术定位、产品形态与临床侧重上形成鲜明互补，这将使小米锁定了国内侵入式脑机接口的两条核心技术路线，同时也为侵入式脑机接口的商业化提供了新范式。01小米官宣与两大脑机接口企业合作12月17日，小米核心系统部总经理牛坤在合作伙伴大会上的宣布，公司已与国内脑机接口领军企业脑虎科技、阶梯医疗展开早期合作，未来脑机接口项目将正式接入米家生态系统，旨在通过意念控制技术降低智能家居使用门槛，助力行动不便的用户实现无障碍生活。从合作背景来看，此次小米与两家公司的合作建立在双方坚实的技术突破基础之上。根据官方披露的信息，脑虎科技于12月13日刚刚完成国内首款“全植入、全无线、全功能”脑机接口产品的首例临床试验；而阶梯医疗则于今年5月推进我国首例侵入式脑机接口系统试验，成功使四肢截瘫患者通过意念操控游戏。有观点指出，此次合作的深层逻辑在于资源互补，两家脑机接口企业提供前沿的临床数据与技术积累，而小米则贡献其庞大的设备生态与用户基础。小米的澎湃OS及超过千万级的智能设备，为脑机接口技术提供了现成的“执行网络”，使技术从实验室走向日常生活成为可能。业内分析认为，这种合作模式将为脑机接口技术提供前所未有的落地场景，其成熟的米家生态链可直接作为脑机信号的“执行网络”，大幅加速技术普及进程。02资源互补构建布局双技术引擎事实上，此次小米选择同时绑定脑虎科技与阶梯医疗，本质是锁定国内侵入式脑机接口的两条核心技术路线。两家企业虽同属医疗级研发阵营，但在技术定位、产品形态与临床侧重上形成鲜明互补，共同构成小米布局的双技术引擎。脑虎科技资料显示，脑虎科技（NeuroXess）成立于2021年，由中国科学院上海微系统与信息技术研究所研究员陶虎与连续创业者彭雷联合创立。作为中国侵入式脑机接口领域的开拓者，脑虎科技的核心技术在于其自主研发的“高通量柔性脑机接口系统”。据悉，脑虎科技的技术突破集中在三个方面：首先是在材料科学领域的创新，采用蚕丝蛋白作为电极载体，植入大脑后会自然溶解，留下柔软、贴合的电极阵列，极大降低了免疫反应和组织损伤；其次是电极设计上的突破，开发出比头发丝还细的柔性电极，能够大规模、微创地植入大脑皮层；最后是系统集成能力的提升，在12月13日完成的临床试验中，成功实现了“全植入、全无线、全功能”三大目标，这意味着设备完全植入体内，无需外部连线，且具备完整的信号采集、处理和传输能力。图源脑虎科技脑虎科技的产品管线主要围绕医疗需求展开，包括针对瘫痪患者的运动功能恢复系统、针对失明患者的视觉皮层刺激装置以及针对癫痫等神经系统疾病的监测与干预设备。与小米的合作，将使其技术从专业医疗场景延伸至更广泛的康复与辅助生活领域。阶梯医疗阶梯医疗（Step Medical）则代表了脑机接口领域的另一种技术路径与商业思考。其核心团队堪称“全明星阵容”：首席科学家卢煜明是“无创产前检测（NIPT）之父”、英国皇家学会院士；CEO袁立是前商汤科技副总裁，拥有丰富的人工智能商业化经验。阶梯医疗的技术特色在于其“高通量、全植入、无线化”的系统级解决方案。与脑虎科技侧重电极材料创新不同，阶梯医疗致力于构建完整的脑机接口生态系统，包括自主研发的高性能神经信号采集芯片、先进的无线能量传输技术以及能够处理海量神经数据的解码算法。图源阶梯医疗今年5月，阶梯医疗完成国内首例侵入式脑机接口系统试验，成功帮助四肢截瘫患者通过意念玩转复杂游戏，展现了其系统在运动意图解码方面的高精度。这一成就不仅证明了技术的可行性，也为脑机接口在更精细操作中的应用奠定了基础。03从可穿戴设备到脑机接口小米在医械的跨界棋局需要指出的是，小米此次与脑机接口企业的合作，并非其在医疗器械领域的首次尝试。回顾小米近年来的发展轨迹，早在2014年小米就通过投资九安医疗旗下iHealth品牌，切入智能血压计、血糖仪等家用医疗设备领域；2017年，小米生态链企业华米科技推出多款医疗级可穿戴设备，并获得医疗器械注册证；2020年，小米直接投资医疗器械研发企业，并在2022年成立北京小米机器人技术有限公司，布局手术机器人等高端医疗装备。然而，与以往投资或生态链合作不同，此次与脑虎科技、阶梯医疗的合作标志着小米在医疗器械领域的布局进入了全新的阶段。首先，技术前沿性大幅提升。从家用监测设备、可穿戴设备到直接与大脑交互的脑机接口，小米切入的医疗器械技术门槛呈指数级提升。这表明了小米在底层技术研发上的决心，也预示着科技巨头在医疗领域的竞争正从应用层向基础技术层延伸。其次，整合深度显著增加。不同于此前简单的投资或产品合作，此次合作明确提出将脑机接口技术“接入米家生态系统”，意味着脑机接口将成为小米“人车家全生态”战略的核心组成部分，而非边缘补充。这种深度整合为脑机接口的商业化提供了难以复制的场景优势。此外，商业模式创新。传统医疗器械的商业模式高度依赖医院采购和专业医疗渠道，而小米的入局可能探索出一条“医疗场景验证、消费场景扩展”的新路径。通过先服务行动不便的患者群体，打磨技术和产品，再逐步扩展到更广泛的消费人群，这种“医疗-消费”双轮驱动的模式，可能为医疗器械行业带来全新的商业想象力。04中国脑机接口发展迎来风口脑机接口（Brain Computer Interfaces, BCI）是指在生物脑与智能机器之间建立信息交流的直接通道，既可以解读脑部信号、控制外部设备，也可以将信息编码输入大脑。脑机接口技术根据技术路径可以分为输出式和输入式两大类。目前脑机接口产业尚无完全统一的分类标准和结果，一种常见的脑机接口分类方法是按照信号的采集方式来分类的，分为侵入式、半侵入式和非侵入式。但长期以来，脑机接口因技术门槛高、成本昂贵，局限于少数顶级医院的临床试验。从市场发展来看，2024年中国脑机接口市场规模为32亿元，增长率为18.8%，预计到2028年将达到61.4亿元，2024年至2028年的年复合增长率为17.7%。全球脑机接口市场规模2023年为23.5亿美元，预计2027年将达到接近40亿美元，2030年至2040年间仅在医疗领域应用的潜在市场规模有望达400亿至1450亿美元。从政策端来看，随着政策环境的根本性变化，近年来我国脑机接口成为新的科技热点与风口。“十三五”以来，脑机接口支持政策频。到2025年，国家药监局发布脑机接口行业标准，首次确立国家标准，促进高质量发展。同时，工信部等七部委明确脑机接口长期发展路径，并提出两大阶段性目标：到2027年,脑机接口关键技术取得突破,初步建立先进的技术体系、产业体系和标准体系；到 2030 年，脑机接口产业创新能力显著提升，形成安全可靠的产业体系，培育 2-3 家有全球影响力的领军企业和一批专精特新中小企业，构建具有国际竞争力的产业生态，综合实力迈入世界前列。目前，国家药监局将脑机接口纳入 “创新医疗器械特别审查程序”，审批周期可缩短至 6-12 个月；湖北省率先发布全国首个脑机接口医疗服务价格，侵入式脑机接口置入费定为 6552 元 / 次，为临床普及打通 “最后一公里”；2025 年初，北京、上海市科委均出台了代表性的地方政策，加速脑机接口产业发展。——当前，中国脑机接口迎来空前快速发展。此次小米与脑虎科技、阶梯医疗的合作，是中国脑机接口产业发展的重要里程碑，当前脑机接口技术正站在医疗与消费的交叉路口，小米的入局加速了这一进程。值得注意的是，小米的跨界布局也面临监管挑战。脑机接口作为植入式医疗器械，受到国家药监局严格的三类医疗器械监管。小米如何平衡技术创新与合规要求，如何构建符合医疗标准的质量体系，将是决定这一跨界尝试成败的关键。对此，器械之家也将持续关注报道。","kind":"news","is_publish_news":true,"is_publish_highlight":false,"is_publish_live":false,"is_publish_wemedia":null,"editions":null,"column":"","sentiment":"0","news_tag":"","news_rank":0,"symbols":[],"gpt_button":0,"need_auth":false,"code":"91000000","status":"200"},"commentList":[],"isCommentEnd":true,"newsSizeData":{"likeSize":0,"commentSize":0,"repostSize":0,"favoriteSize":0,"likeStatus":false,"favoriteStatus":false},"APP":{"userAgent":"Mozilla/5.0 AppleWebKit/537.36 (KHTML, like Gecko; compatible; ClaudeBot/1.0; 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