The FDA's Neurological Devices Advisory Committee voted 9-2 in favor of expanding the indication for transcranial magnetic stimulation to adolescents aged 15 to 21 with treatment-resistant major depressive disorder. While the vote is non-binding, the agency typically follows committee recommendations on neurological device labeling within six months.
Currently, TMS is FDA-cleared only for adults 18 and older for major depressive disorder. Pediatric and adolescent use occurs off-label at academic medical centers under research protocols. The advisory vote was based on a 169-patient sham-controlled trial in adolescents that showed a 56% response rate compared with 26% for sham.
The two dissenting committee members raised concerns about long-term cortical development data and the lack of standardized motor threshold protocols in younger patients, whose skulls and brain volumes are still maturing. Both voted to defer rather than against the indication outright.
If the FDA follows the recommendation, Neuronetics' NeuroStar would likely be the first device to receive an updated label. Coverage for adolescent depression — currently the leading cause of disability among U.S. teenagers — has been a longstanding policy priority of the American Academy of Child and Adolescent Psychiatry.
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Reporting based on coverage from FDA Newsroom. This article is editorial summary intended for general information; it is not medical advice.