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[Roadmap of Medical Device for Implanted Brain-computer Interface].

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
Summary
This summary is machine-generated.

Implanted brain-computer interfaces (iBCIs) offer a direct brain-computer link for neurological conditions. This review explores iBCI industrialization, clinical translation, and regulatory pathways, highlighting collaborative needs for future development.

Keywords:
active implantable medical devicesimplanted brain-computer interface (iBCI)regulation and guidance

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Area of Science:

  • Neuroscience
  • Biomedical Engineering
  • Medical Device Technology

Background:

  • Implanted brain-computer interfaces (iBCIs) create direct communication pathways between the brain and external devices via neural electrodes.
  • iBCIs show significant potential as platform technologies for individuals with nervous system disorders, progressing from research to clinical applications.
  • The rapid advancement of iBCI technology necessitates a review of its industrialization and translational pathways.

Conclusions:

  • The clinical application and industrialization of iBCI as medical devices face complexities.
  • Successful translation and market access require close collaboration between regulatory bodies, industry, academia, and healthcare institutions.
  • Future development hinges on interdisciplinary cooperation to navigate regulatory and clinical challenges.