植入式脑机接口技术的医疗器械之路

Roadmap of Medical Device for Implanted Brain-computer Interface

植入式脑机接口(implanted brain-computer interface, iBCI)通过植入大脑内的神经电极实现脑和计算机/机器的直接通信。它作为一种极具功能扩展性的神经科学研究技术,正在快速向有源植入式医疗器械转化。该研究回顾了国内外神经植入医疗技术的器械产品化历史,提出了植入式脑机接口向医疗器械转化的方式和路径,阐述了美国食品和药品管理局(FDA)把植入式脑机接口作为突破性医疗器械推动的相关政策,并简单介绍和比较了目前正在申请临床试验的几款植入式脑机接口技术方案。由于植入式脑机接口技术复杂,以及没有类似的临床医疗器械先例,医械监管部门和产学研医用各方的密切合作才能有效推动植入式脑机接口技术的临床转化和医疗器械产品化。

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.