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[用于植入脑机接口的医疗设备的路线图]

Tao Su1,2, Chunshan Deng1,2, Xiaojian Li1,2

  • 1Shenzhen Institute of Advanced Technology, Chinese Academy of Sciences, Shenzhen, 518055.

Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation
|June 8, 2023
PubMed
概括
此摘要是机器生成的。

植入的脑电脑接口 (iBCI) 为神经疾病提供直接的脑电脑连接. 本综述探讨了iBCI产业化,临床转化和监管途径,强调了未来发展的合作需求.

关键词:
活跃的植入式医疗器械植入的大脑与计算机接口 (iBCI)监管和指导的规定和指导.

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科学领域:

  • 神经科学是一个神经科学.
  • 生物医学工程 生物医学工程
  • 医疗器械技术 医疗器械技术

背景情况:

  • 植入的大脑与计算机接口 (iBCI) 通过神经电极在大脑和外部设备之间创建直接通信通道.
  • 作为神经系统疾病患者的平台技术,iBCI具有显著的潜力,从研究发展到临床应用.
  • 由于iBCI技术的快速发展,需要对其工业化和转化途径进行审查.

研究的目的:

  • 审查植入神经调节医疗器械的工业化过程.
  • 为iBCI在临床应用中提出一个转化途径.
  • 检查监管环境,特别是FDA对iBCI作为突破性设备的指导方针.

主要方法:

  • 对植入神经调节医疗器械的工业化过程的审查.
  • 在临床环境中对iBCI的转化途径的分析.
  • 审查食品和药物管理局 (FDA) 对iBCI的规定和指南.
  • 简要介绍和比较申请医疗器械注册的iBCI产品.

主要成果:

  • iBCI设备正在迅速发展,从神经科学发现到翻译应用和市场准入.
  • 美国食品和药物管理局正在为iBCI制定规定,将其视为突破性的医疗器械.
  • 目前,一些iBCI产品正在经历医疗器械注册流程.

结论:

  • 作为医疗器械的iBCI的临床应用和工业化面临着复杂性.
  • 成功的翻译和市场准入需要监管机构,行业,学术界和医疗机构之间的密切合作.
  • 未来的发展取决于跨学科合作,以应对监管和临床挑战.