Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices.

Abstract

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