FDA Expands MagVenture TMS Indications to Treat MDD, OCD, and Anxious Depression with One Coil

MagVenture® announces FDA clearance expanding the indications for its MagVenture TMS Therapy™ system to include treatment of Major Depressive Disorder (MDD) with comorbid anxiety symptoms* in adults and broadening approved coil compatibility across both MDD and Obsessive-Compulsive Disorder (OCD)** now allowing for multiple indications all available using one treatment coil.

The clearance allows providers to treat adult MDD patients experiencing symptoms of anxiety, a highly prevalent and clinically challenging population. Research shows that more than half of patients with MDD also suffer from comorbid anxiety symptoms, often referred to as “anxious depression.” This group faces more severe symptoms, reduced response to standard therapies, and higher relapse rates—making new treatment options essential.

“With this expanded indication, we’re equipping clinicians to better serve patients whose depression is accompanied by anxiety symptoms—one of the most common and burdensome presentations in outpatient mental health care,” said Kerry Rome, Senior Vice President, MagVenture Inc. “It reflects our long-standing commitment to providing clinically validated, adaptable solutions that evolve alongside provider needs.”

The FDA clearance also expands the number of approved treatment coils for MDD and OCD. In addition to the previously cleared MagVenture Cool-B70 and Cool-B65 coils for MDD, and Cool D-B80 for OCD, this update now authorizes treatment using MagVenture’s Cool D-B80, Cool-B70, and Cool-B65 for both conditions. This gives MagVenture providers greater flexibility to tailor therapy based on clinical objectives, anatomical targets, or patient comfort – now using one coil for multiple indications.

“Each coil geometry offers unique field distribution properties, allowing clinicians to stimulate broad, deep, or selective areas of the brain,” added Rome. “With this expanded portfolio, our users can now choose the most appropriate coil for each specific patient, prioritizing comfort, treatment precision, and outcomes.”

“We are incredibly proud of these achievements,” said Christian Wanding, Chief Commercial Officer of MagVenture A/S. “These advancements reinforce MagVenture’s commitment to empowering providers with versatile, cutting-edge solutions that help improve the lives of patients.”

Nearly all major US commercial insurers now cover TMS for MDD, including patients who also experience comorbid anxiety, often referred to as anxious depression. Leading payers such as UnitedHealthcare, Anthem Blue Cross Blue Shield, Aetna, Cigna, Humana, and others recognize TMS as a proven treatment option. Government programs, including Medicare and TRICARE, also cover TMS for adults with treatment-resistant depression under defined clinical criteria. Coverage for TMS in OCD is emerging. Some private insurers, including Cigna and select Blue Cross Blue Shield plans such as Highmark BCBS, have adopted positive policies for adults with OCD who meet strict treatment-resistance requirements. However, Medicare, Medicaid, and several large commercial payers do not currently provide coverage.

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)