BrainsWay expands treatment access to young people aged 15–21
BrainsWay has announced a significant milestone for youth mental health: the U.S. Food and Drug Administration (FDA) has granted clearance for the company’s Deep Transcranial Magnetic Stimulation (Deep TMS™) system to be used as an adjunct treatment for adolescents aged 15 to 21 living with major depressive disorder (MDD).
This makes Deep TMS™ the first and only TMS technology cleared for use across such a wide age range—from 15 through 86—marking an important expansion in noninvasive treatment options for depression.
Bringing a New Option to an Underserved Age Group
Adolescents with MDD often face limited effective treatment choices, particularly when medication alone does not provide sufficient relief. BrainsWay’s Vice President of Medical Affairs, Dr. Colleen Hanlon, highlighted the importance of the new clearance, noting that the submission included one of the most extensive collections of real-world data ever provided to the FDA for adolescent neuromodulation.
The evidence, drawn from 1,120 adolescents treated across 35 U.S. clinics between 2012 and 2024, demonstrated meaningful reductions in depressive symptoms along with improvements in co-occurring anxiety. Outcomes from both 18 Hz and intermittent theta-burst Deep TMS protocols were assessed. After a standard course of 36 sessions, adolescents showed an average 12-point reduction on the PHQ-9 depression scale, with two-thirds achieving at least a 50% improvement, and anxiety scores (GAD-7) also showed notable decreases. Safety outcomes were consistent with findings from adult treatment studies.
A Step Forward for Families and Clinicians
BrainsWay CEO Hadar Levy emphasized that the clearance represents hope for families seeking additional options for young people struggling with depression. With an estimated 5 million adolescents in the U.S. experiencing a major depressive episode in the past year alone, expanding clinical tools for this age group is an urgent priority.
An added benefit for clinicians is that adult and adolescent patients can now be treated using the same Deep TMS™ hardware and well-established protocols, supporting more streamlined integration into clinical practice.
About the Expanded Indication
Deep TMS™ is now cleared for:
- Treating depressive episodes in adults with MDD who have not achieved adequate improvement through antidepressant medication, including reductions in comorbid anxiety symptoms.
- Use as an adjunct therapy for adolescents aged 15–21 diagnosed with MDD.
Globally, MDD remains one of the leading causes of disability. For individuals who do not respond to traditional treatments, the consequences can include prolonged distress, increased healthcare needs, and elevated risk of complications such as substance use or suicidality. Noninvasive neuromodulation technologies like Deep TMS™ offer an important alternative pathway for care.
About BrainsWay
BrainsWay develops advanced, noninvasive neurostimulation technologies for psychiatric, neurological, and addiction-related conditions. Its proprietary Deep TMS™ platform is backed by multiple pivotal clinical trials and holds three FDA-cleared indications: major depressive disorder, obsessive-compulsive disorder, and smoking addiction.
Founded in 2003 and operating in both the U.S. and Israel, the company continues to expand clinical research into additional conditions while working to increase global accessibility to Deep TMS™ treatments.
For more information, read the original article or visit the BrainsWay website
