Key result
FDA-approved neuromodulation shows systematic safety documentation but modest efficacy across 125 reviewed records.
Why the study?
Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices.
Systematic Review (n=125)
p-value: p=< 0.001
FDA approvals for neuromodulation devices are largely supported by industry-funded trials that show systematic safety documentation but modest efficacy, with persistent gaps in minority representation and longitudinal data.
Supports cautious neuromodulation device use given modest efficacy; challenges adequacy of current FDA approval evidence standards.
INTRODUCTION: Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices. METHODS: From 1960 to 2023, 125 FDA-approved neuromodulation records corresponding to 109 publications (64 randomized, 45 nonrandomized trials) were identified. Regulatory records and published trial characteristics were reviewed. CONCLUSIONS: Our findings reveal considerable heterogeneity in the evidence supporting neuromodulation devices, with trials showing systematic safety documentation but modest efficacy. Industry-funded trials dominate the evidence base, with recalls primarily limited to invasive technologies. Evidence gaps persist in minority representation and longitudinal data.
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Almarie et al. (2025) conducted a systematic review in Neuromodulation devices (n=125). Neuromodulation devices was evaluated (p=< 0.001). A systematic review of 125 FDA-approved neuromodulation records revealed considerable heterogeneity in evidence, showing systematic safety documentation but modest efficacy.
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