Roadmap of Medical Device for Implanted Brain-computer Interface / 中国医疗器械杂志
Chinese Journal of Medical Instrumentation
;
(6): 304-308, 2023.
Artículo
en Chino
| WPRIM
| ID: wpr-982233
ABSTRACT
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.
Texto completo:
Disponible
Índice:
WPRIM (Pacífico Occidental)
Asunto principal:
Encéfalo
/
Electrodos Implantados
/
Interfaces Cerebro-Computador
Límite:
Humanos
Idioma:
Chino
Revista:
Chinese Journal of Medical Instrumentation
Año:
2023
Tipo del documento:
Artículo
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