Is TMS FDA approved?

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.