脑机接口医疗器械

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中国光谷出台措施加快发展脑机接口产业
Zhong Guo Xin Wen Wang· 2025-10-09 02:58
8月,湖北脑机接口产业创新发展联盟在光谷成立。目前,东湖高新区正推进建设光谷脑机接口产业集 聚区,其创新驱动核——国际脑机接口创新中心,由东湖高新区联合同济医院、协和医院等单位建设, 将构建从概念验证、临床试验、注册检验到产业转化的全链条服务体系。(完) 据了解,为推进脑机接口产业建设,光谷明确"五个一"实施路径,即成立一个产业联盟、建设一个特色 园区、出台一项专项政策、发布一批应用场景、设立一支产业基金。 《措施》围绕加强技术产品攻关、推动技术成果应用、壮大创新主体、构建产业创新生态等方面,推出 系列政策举措。其中,在技术产品攻关方面,支持脑机接口领域企业联合高校院所、医疗机构,在运动 控制、言语合成、神经疾病治疗、视觉重建等方面研发重大脑机接口产品,同时支持脑机接口医疗器械 研发;在技术成果应用方面,支持建设脑机接口试验服务平台、脑机接口试验设备共享平台,支持脑机 接口产品首试首用。 为壮大脑机接口产业创新主体,《措施》提出,支持打造脑机接口创新中心,给予每年最高1000万元运 营资金支持;鼓励脑机接口企业联合湖北实验室、光电子领域龙头企业组建产业联合共同体,推动在医 疗领域、康养领域和工业安全领域示范应 ...
提供统一权威“通用语言” 我国首部脑机接口医疗器械标准发布
Yang Shi Xin Wen· 2025-09-27 09:30
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].