Page 58 - 《中国医疗器械杂志》2026年第1期

Chinese Journal of Medical Instrumentation 2026年 第50卷 第1期

综 合 评 述

文章编号：1671-7104(2026)01-0054-10

光学脑机接口技术进展综述及医疗器械检测技术展望

【作 者】 王一乔 ，宓云軿 ，张鑫衍 ，赵斌 ，李昊 ，刘勋 1,2
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1 上海市医疗器械检验研究院，上海市，201318
2 国家药品监督管理局医用电气设备重点实验室，上海市，201318
3 上海市医疗器械化妆品审评核查中心，上海市，200020
4 国家药品监督管理局医疗器械技术审评检查长三角分中心，上海市，201210
5 临港实验室，上海市，200031
【摘 要】 光学脑机接口（optical brain-computer interface, OBCI）技术是一种基于光学方式通过神经工程手段实现
人脑与外部设备信息交互的新型交叉前沿技术。其中基于功能性近红外光谱技术（functional near-infrared
spectroscopy, fNIRS）的脑机接口（brain-computer interface, BCI）设备已相继被研发运用，这类技术成
为无创光学脑机接口医疗器械技术的主要发展方向之一。同时，基于光遗传学、光学钙成像技术的光学脑
机接口技术近年来也被提出成为研究热点，将作为光学脑机接口医疗器械检测技术未来发展的新方向。该
文主要综述了功能性近红外光谱脑机接口（fNIRS-BCI）的基本原理及研究进展，介绍了基于光遗传学、光
学钙成像技术的脑机接口研究前沿。最后，对光学脑机接口医疗器械检测技术的进一步发展提出展望，为
该类脑机接口产业发展及检测、监管提供一定的指导和思路。
【关 键 词】 光学脑机接口；脑机接口；功能性近红外光谱；光遗传学；光学钙成像
【中图分类号】 R318; TN911.7
【文献标志码】 A doi: 10.12455/j.issn.1671-7104.250262
Review of Progress of Optical Brain-Computer Interface Technology and
Prospects for Medical Device Testing Technology

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【 Authors 】 WANG Yiqiao , MI Yunping , ZHANG Xinyan , ZHAO Bin , LI Hao , LIU Xun 1,2
1 Shanghai Institute of Medical Device Testing, Shanghai, 201318
2 NMPA Key Laboratory for Medical Electrical Equipment, Shanghai, 201318
3 Shanghai Medical Device and Cosmetics Evaluation and Verification Center, Shanghai, 200020
4 Yangtze River Delta Center for Medical Device Evaluation and Inspection of NMPA, Shanghai, 201210
5 Lin Gang Laboratory, Shanghai, 200031
【 Abstract 】 Optical brain-computer interface (OBCI) technology is a new cross-cutting frontier technology that
achieves information interaction between the human brain and external devices through neuroengineering
based on optical methods. Among them, brain-computer interface (BCI) devices based on functional
near-infrared spectroscopy (fNIRS) have been successively developed and applied, and this type of
technology has become one of the main development directions of non-invasive optical brain-computer
interface medical device technology. At the same time, OBCI technology based on optogenetics and
optical calcium imaging technology has also been proposed as a research hotspot in recent years, and
will serve as a new direction for the future development of OBCI medical device testing technology. This
paper mainly reviews the basic principles and research progress of functional near-infrared spectroscopy
brain-computer interface (fNIRS-BCI), and introduces the research frontiers of BCI based on optogenetics
and optical calcium imaging technology. Finally, it presents prospects for the further development of OBCI
medical device testing technology, providing certain guidance and ideas for the development, testing, and
supervision of the BCI industry.

收稿日期：2025-04-17
基金项目：上海市市场监督管理局2024年度技术保障类项目（2024BZ21）
作者简介：王一乔，E-mail: yqwang0517@163.com
通信作者：刘勋，E-mail: liuxun_hust@126.com

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