FDA Clears BrainsWay’s TMS Device for Adolescents with MDD Aged 15 to 21 Years

The US Food & Drug Administration (FDA) has cleared BrainsWay’s Deep Transcranial Magnetic Stimulation (Deep TMS) system for use as an adjunct therapy in adolescents aged 15 to 21 years with major depressive disorder (MDD).1

The news, announced on November 13, 2025, expands the use of the TMS device, which had previously been approved for patients aged 22 – 86 years in 2018.2

“The FDA’s clearance of this expanded label enables access to Deep TMS for the critically important adolescent patient population, which is often underserved by traditional pharmacological options to manage major depressive disorder,” said Colleen Hanlon, VP of Medical Affairs, BrainsWay Ltd, in a statement. “The 510(k) clearance was supported by our submission of one of the largest real-world adolescent neuromodulation datasets ever presented to the US FDA, which demonstrated compelling efficacy and safety in reducing depressive symptoms, as well as substantial improvements in comorbid anxiety.”

The TMS device offers noninvasive magnetic stimulation through a cushioned helmet to induce electrical currents in localized regions of the prefrontal cortex. The treatment requires daily sessions of 20 minutes throughout 4 – 6 weeks.2 Although the treatment may take a few weeks to start improving MDD symptoms, patients may notice subtle improvements sooner, such as being more alert, having more energy during the day, or having more patience.3

In the study supporting the expanded use of the TMS device, patients aged 15 to 21 years with MDD received 36 sessions of either high-frequency (18 Hz) Deep TMS or intermittent theta-burst stimulation.1 The analysis demonstrated an average improvement of 12.1 points on the self-administered Patient Health Questionnaire-9 (PHQ-9) rating scale and a 66.1% response rate (improvement from baseline of ≥50%). Investigators also observed improvements in anxiety, reflected by changes in self-administered Generalized Anxiety Disorder (GAD-7) scale scores.

Overall, the treatment was well-tolerated with similar adverse events as observed in adult studies.1 Previous studies with participants aged 22 – 86 years found no known systemic effects; the most common adverse events included headaches and local discomfort, often mild and temporary. Other adverse events included muscle twitching and jaw pain.2

Along with MDD, the FDA has cleared BrainsWay’s Deep TMS system for the treatment of obsessive-compulsive disorder (OCD), anxious depression, and smoking cessation.1

References

1. BrainsWay Deep TMS Gains FDA Clearance for Adolescent Depression. MPR. Published November 13, 2025. Accessed November 14, 2025. https://www.empr.com/news/brainsway-deep-tms-gains-fda-clearance-for-adolescent-depression/

2. Payesko J. BrainsWay’s Next Generation Stimulator For Treatment of MDD Cleared by FDA. Hcplive. Published May 9, 2018. Accessed November 14, 2025. https://www.hcplive.com/view/brainsways-next-generation-stimulator-for-treatment-of-mdd-cleared-by-fda

3. Sehic A. What is a BrainsWay Deep TMS Device? BrainsWay. Published December 15, 2022. https://www.brainsway.com/knowledge-center/what-is-a-brainsway-deep-tms-device/