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Is TMS FDA approved?

Quick Answer

Yes, TMS is FDA-approved. It was first approved in 2008 for treatment-resistant depression, and has since received additional approvals for OCD (2018) and other conditions.

Detailed Answer

TMS has received multiple FDA clearances, establishing it as a legitimate, evidence-based medical treatment:

**Major Depressive Disorder (2008)**: The first FDA clearance was granted for treating adults with MDD who haven't responded to at least one antidepressant medication.

**Obsessive-Compulsive Disorder (2018)**: BrainsWay's Deep TMS system received clearance for OCD treatment.

**Migraine (2013)**: Single-pulse TMS devices were cleared for acute migraine with aura.

FDA clearance requires rigorous clinical trials demonstrating both safety and efficacy. For depression, pivotal trials showed significant improvement rates without the systemic side effects of medications.

Multiple TMS devices from different manufacturers have received clearance, including NeuroStar, BrainsWay, MagVenture, and CloudTMS. Each device undergoes independent review of safety data and clinical effectiveness.

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Medical Disclaimer

The information provided on this page is for educational purposes only and is not intended as medical advice. TMS List does not provide medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any questions you may have about a medical condition or treatment.

Last Updated: April 15, 2026