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PubMed

Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis.

PMID: 40542709 ·

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RevistaExpert review of medical devices
Ano
PMID40542709

Resumo

Integration of clinical trials into FDA approval processes is essential for ensuring the safety and efficacy of neuromodulation devices. 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. Safety outcomes were reported in 95.4% of randomized and 82.2% of nonrandomized trials, with serious adverse events in ~ 75% of the studies.

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