ReviewChildren (Basel, Switzerland)2025
Bridging the Gap in FDA Approval for Pediatric Neuromodulation Devices.
Review in Children (Basel, Switzerland), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
3 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Evidence and Future Directions for Pediatric Health Care Chatbots: Systematic Review.Journal of medical Internet research · 2026Pooled it
- Pediatric migraine: Neurodevelopmental mechanisms, clinical phenotypes, and modern therapeutics.World journal of clinical pediatrics · 2026Review
- Perioperative Management of Pediatric Epilepsy Neuromodulation Devices.Children (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
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 concerns, small trial populations, and financial disincentives due to the limited market size-continue to hinder progress. This review examines these barriers to pediatric neuromodulation device development and FDA (Food and Drug Administration) approval, as well as the current efforts, such as FDA initiatives and consortia support, that address regulatory and financial challenges. Furthermore, we discuss pathways like the Humanitarian Device Exemptions and Real-World Evidence programs that aim to streamline the approval process and address unmet clinical needs in pediatric care. Addressing these barriers could expand access to effective neuromodulation treatments and improve patient care.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.