FDA Clearance to Expand TMS Therapy Indication for Adolescents Aged 15–21

MagVenture, the global leader of non-invasive TMS neuromodulation technology, announced that the U.S. Food and Drug Administration (FDA) has granted clearance for an expanded indication of its MagVenture TMS Therapy™ system*. The system is now indicated as an adjunct treatment for Major Depressive Disorder (MDD) in adolescent patients aged 15 to 21 who have not responded adequately to prior antidepressant medication.

This clearance allows U.S.-based providers using MagVenture systems to now offer this safe, effective, and non-pharmacological therapy to adolescent patients, supporting a growing clinical demand for alternative depression treatments in younger populations.

Up to 20% of adolescents will have a major depressive episode before adulthood, meaning that the mental health needs of this demographic are both urgent and complex. Many teens face barriers to sustained medication use, with non-compliance rates up to 60%, making alternative treatment options increasingly relevant.

MagVenture TMS Therapy utilizes magnetic pulses generated by MagVenture’s liquid-cooled treatment coils to stimulate neurons in areas of the brain associated with depression, including the left dorsolateral prefrontal cortex (DLPFC). This region is closely linked with mood regulation. TMS is a noninvasive procedure and does not require anesthesia or systemic medication. Each session typically lasts about 20 minutes and can be seamlessly integrated into a patient’s weekly schedule without the need for recovery time.

For adolescent patients, the clinical promise of TMS is significant. Treatment benefits may last up to six months, offering patients and their families a meaningful window of symptom relief and recovery.

TMS therapy is considered safe and effective for adolescent use, with the most commonly reported side effect being temporary discomfort at or near the treatment site, usually occurring early in the treatment course. Overall, MagVenture TMS Therapy has demonstrated a favorable safety profile and offers a viable adjunctive treatment for adolescents with MDD who may not benefit from or cannot tolerate pharmacologic therapies alone.

MagVenture has also recently cleared the T65 coil that be used for treatment of MDD. T65 coil—MagVenture’s lightest cooled coil—combines the functionality of the C-B60 and Cool-B65 into a single solution for both motor threshold measurement and treatment. With a lighter-weight, quieter performance, quick-connect design, and longer lifetime, the T65 is engineered to reduce operator fatigue, improve the patient experience, and increase workflow efficiency while maintaining the proven magnetic field properties of the Cool-B65.

Kerry Rome, Senior Vice President of MagVenture Inc., noted that these regulatory milestones reinforce the company’s broader commitment to innovation and access. “This expanded FDA indication and introduction of the T65 coil advance our mission to make effective, non-invasive treatment accessible to more patients. We strive to support clinicians with technologies that are grounded in evidence, adaptable in practice, and driven by real patient needs.”

MagVenture’s TMS systems are widely used across academic institutions, private clinics, and hospital networks, with a reputation for precision engineering, flexible protocols, and integrated safety features. The addition of the adolescent indication enables current and new MagVenture customers to meet the needs of a growing patient group with confidence and continuity of care.

Media inquiries:

Kerry Rome kr@magventure.com or Lauren Schultheiss ls@magventure.com, MagVenture, Inc., +1.888.624.7764

This news refers to FDA-cleared indications for use in the United States only. The products are not CE-marked and are not available for sale or clinical use in the European Union or other markets outside the US.

*The MagVenture TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from prior antidepressant medication treatment in the current episode.

**MagPro stimulators R30, R30 with MagOption, X100 and X100 with MagOption are all FDA 510 (k) cleared as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD)