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

Alpharetta, GA — September 2, 2025

MagVenture®, the global leader in non-invasive TMS therapy, 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.

About MagVenture

MagVenture develops and manufactures non-invasive magnetic stimulation systems used globally in psychiatry, neurophysiology, neurology, cognitive neuroscience, rehabilitation, and pain management. With over three decades of experience in the field, the company is committed to delivering safe, effective, and future-facing treatment technologies that empower healthcare professionals and support better outcomes for patients of all ages.

Media inquiries:

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