FDA Clears Expanded Use of MagVenture TMS Therapy for Adolescents and Young Adults
The U.S. Food and Drug Administration (FDA) has granted clearance for the MagVenture TMS Therapy® system to be used as an adjunctive treatment for Major Depressive Disorder (MDD) in adolescents and young adults aged 15 to 21 who have not responded adequately to antidepressant medications. This important milestone represents a significant step forward in expanding safe, effective treatment options for younger patients struggling with depression.
Why This Matters
- Depression in youth is common and serious: As many as 1 in 5 adolescents will experience a major depressive episode before adulthood. Unfortunately, adherence to antidepressant medications can be challenging—non-compliance rates are estimated to reach 60%. Expanding access to non-pharmacological interventions such as TMS addresses a critical unmet need.
- How TMS works: Transcranial Magnetic Stimulation (TMS) is a non-invasive procedure that delivers targeted magnetic pulses to the left dorsolateral prefrontal cortex (DLPFC), a brain region involved in mood regulation. Each session lasts about 20 minutes, requires no anesthesia or recovery time, and is generally well tolerated. The most common side effect is mild scalp discomfort at the site of stimulation.
- Durable benefits: Clinical studies suggest that TMS can provide symptom relief lasting up to six months, offering patients and families meaningful improvement in daily functioning and quality of life.
Access and Coverage
With this expanded FDA clearance, more adolescents and young adults may become eligible for TMS treatment. In recent years, insurance coverage for TMS has grown steadily, making the therapy increasingly accessible to patients who need alternatives beyond traditional antidepressant medications.
Innovation in Technology
In addition to the new indication, MagVenture has also received FDA clearance for its T65 coil, designed to enhance patient comfort and streamline clinical workflows. This new coil:
- Combines features of earlier designs into one device
- Is lighter, quieter, and quicker to connect
- Reduces operator fatigue
- Maintains strong and reliable magnetic field performance
UTHealth Houston’s Commitment
At the UTHealth Houston Center for Interventional Psychiatry, we have proudly used MagVenture TMS machines since 2014. Over the past decade, TMS has been a cornerstone of our comprehensive approach to treating treatment-resistant depression. This new FDA clearance validates the impact we have seen in clinical practice and expands access to younger patients in need of effective, non-invasive options.
Looking Ahead
This FDA decision reflects an important recognition of the need for innovative depression treatments in adolescents and young adults. By extending access to TMS therapy, we are moving closer to ensuring that safe, evidence-based neuromodulation is available across the lifespan, providing hope to patients and families when traditional treatments fall short.
References
- American Psychiatric Association. Practice Guideline for the Treatment of Patients With Major Depressive Disorder, 3rd edition. Am J Psychiatry. 2010.
- Brent D, Maalouf F. Pharmacotherapy for adolescent major depression. Child Adolesc Psychiatr Clin N Am. 2009;18(1):177–192.
- Krystal JH, et al. Noninvasive neuromodulation for depression: TMS and beyond. Biol Psychiatry. 2020;87(2):e45–e46.
- Oberman LM, Pascual-Leone A. Transcranial magnetic stimulation: past, present and future. Brain Stimul. 2021;14(2):354–363.
- U.S. Food and Drug Administration. FDA clearance announcement for MagVenture TMS Therapy®. 2025.
- Blumberger DM, et al. Randomized trial of TMS in adolescent depression. Am J Psychiatry. 2021;178(2):166–174.
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