医疗器械
接口(物质)
转化研究
过程(计算)
食品药品监督管理局
计算机科学
证书
脑植入物
医学
风险分析(工程)
生物医学工程
人工智能
病理
操作系统
气泡
算法
最大气泡压力法
作者
Tao Su,Chunshan Deng,Xiaojian Li
出处
期刊:PubMed
日期:2023-05-30
卷期号:47 (3): 304-308
标识
DOI:10.3969/j.issn.1671-7104.2023.03.014
摘要
Implanted brain-computer interface (iBCI) is a system that establishes a direct communication channel between human brain and computer or an external devices by implanted neural electrode. Because of the good functional extensibility, iBCI devices as a platform technology have the potential to bring benefit to people with nervous system disease and progress rapidly from fundamental neuroscience discoveries to translational applications and market access. In this report, the industrialization process of implanted neural regulation medical devices is reviewed, and the translational pathway of iBCI in clinical application is proposed. However, the Food and Drug Administration (FDA) regulations and guidances for iBCI were expounded as a breakthrough medical device. Furthermore, several iBCI products in the process of applying for medical device registration certificate were briefly introduced and compared recently. Due to the complexity of iBCI in clinical application, the translational applications and industrialization of iBCI as a medical device need the closely cooperation between regulatory departments, companies, universities, institutes and hospitals in the future.
科研通智能强力驱动
Strongly Powered by AbleSci AI