PubMed

FDA에서의 소아 신경 조절 장치 승인 간의 간격을 메우다.

PMID: 40003250 · 2025-01-27

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학술지Children (Basel, Switzerland)

연도2025-01-27

PMID40003250

초록

While neuromodulation devices for managing neurological conditions have significantly advanced, there remains a substantial gap in FDA-approved devices specifically designed for pediatric patients. Devices like deep brain stimulators (DBS), vagus nerve stimulators (VNS), and spinal cord stimulators (SCS) are primarily approved for adults, with few options for children. To meet pediatric needs, off-label use is common; however, unique challenges to pediatric device development-such as ethical con

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