Brain Ultimate TMS Earns FDA Clearance for OCD Treatment and Theta Burst Stimulation for Depression

Brain Ultimate TMS Receives FDA Clearance for OCD and Theta Burst Stimulation for MDD

Caputron is proud to announce that the Brain Ultimate TMS system has received new FDA 510(k) clearances, expanding its clinical applications and further strengthening its position as a leader in non-invasive brain stimulation technology.

The Brain Ultimate TMS system is now FDA-cleared for:

• Treatment of Obsessive-Compulsive Disorder (OCD) (K243459)

• Intermittent Theta Burst Stimulation (iTBS) for Major Depressive Disorder (MDD) (K243460)

These important milestones mark a significant advancement in mental health treatment, offering clinics and healthcare providers broader, proven options for addressing two of the most challenging psychiatric conditions.

OCD Treatment Clearance

With the new clearance for Obsessive-Compulsive Disorder, Brain Ultimate TMS can now provide patients struggling with OCD access to a non-invasive, effective, and well-tolerated treatment option. The system uses a specialized Double Cone Coil designed to deliver the precise targeting and depth required for OCD protocols.

iTBS Clearance for MDD

Intermittent Theta Burst Stimulation (iTBS) is an innovative and highly efficient treatment protocol for Major Depressive Disorder. iTBS sessions are significantly shorter than traditional TMS protocols, typically lasting only 3 to 5 minutes, while maintaining comparable efficacy. With the new FDA clearance, Brain Ultimate TMS users can now integrate iTBS into their practices, improving patient throughput and overall accessibility.

What This Means for Your Practice

Brain Ultimate TMS continues to offer exceptional versatility, now with the flexibility to treat both MDD and OCD using FDA-cleared protocols, including advanced iTBS treatments. Combined with its intuitive software, liquid cooling technology, and unlimited protocol customization, Brain Ultimate TMS provides clinicians with a future-ready solution to meet the evolving needs of mental healthcare.

We invite you to review the attached FDA protocols and settings to learn more about how to implement these treatments in your clinic.

For questions or to take advantage of the limited-time coil promotion, please contact our team today.