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China's First Subdural Implantable Flexible Brain-Computer Interface Enters 'Green Channel'

国内首款硬膜下植入式柔性脑机接口进入“绿色通道”

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This document reports that BrainCo's implantable brain-computer interface system has become the first subdural flexible BCI product to enter the National Medical Products Administration's innovative medical device expedited review process, following a June 2024 regulation classifying invasive BCIs as Class III medical devices.
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《科创板日报》21日讯,脑虎科技今日宣布,其自主研发的“植入式脑机接口手部运动功能代偿系统”(即“全植入、全无线、全功能”脑机接口系统,简称“三全”系统)通过公示,正式进入国家药品监督管理局医疗器械技术审评中心(CMDE)的创新医疗器械特别审查程序。这是国内首个进入该“绿色通道”的硬膜下植入式柔性脑机接口产品。今年6月,国家药监局发布相关文件,明确侵入式/植入式脑机接口统一按最高规格的“第三类医疗器械”管理。创新医疗器械特别审查程序(即“绿色通道”)则旨在鼓励医疗器械研究与创新、促进新技术推广应用。<br> “特别声明:以上作品内容(包括在内的视频、图片或音频)为凤凰网旗下自媒体平台“大风号”用户上传并发布,本平台仅提供信息存储空间服务。<br> Notice: The content above (including the videos, pictures and audios if any) is uploaded and posted by the user of Dafeng Hao, which is a social media platform and merely provides information storage space services.”