【摘要】 脑机接口(BCI)技术作为生命科学、信息科学等多学科交叉融合的前沿领域，正处于从基础研究向临床转化与产业应用的关键发展阶段。本文系统回顾了BCI技术的演进脉络，重点阐述其在运动功能重建、语言交流辅助、感知觉代偿、意识障碍评估、认知障碍识别以及神经精神疾病诊治等方面的临床进展与未来趋势。结合我国近期推出的BCI产业支持政策，文章进一步探讨了该技术在医疗器械审评审批与伦理治理方面的当前特征，提出构建风险分级框架、加强专业审评能力建设、推动多方协同治理等发展路径，旨在促进BCI技术安全、有效地服务于临床实践与公众健康。更多还原

【Abstract】 Brain-computer interface (BCI) technology,a cutting-edge field arising from the interdisciplinary integration of life sciences,information science,and related disciplines,is currently at a critical stage of transition from basic research to clinical translation and industrial application.This article systematically reviews the developmental trajectory of BCI technology,with particular emphasis on its clinical progress and future prospects in areas including motor function restoration,assisted communication,sensory compensation,assessment of disorders of consciousness,identification of cognitive impairment,and the diagnosis and treatment of neurological and psychiatric disorders.In the context of China’s recently introduced policies supporting the BCI industry,the paper further examines the current characteristics of BCI technology in medical device evaluation and approval,as well as ethical governance.From the perspective of regulatory science,it proposes developmental pathways such as establishing a risk-based classification framework,strengthening specialized review capacity,and promoting multi-stakeholder collaborative governance,aiming to facilitate the safe,effective,and responsible integration of BCI technology into clinical practice and public health.更多还原