FDA Clears Deep TMS as Adjunct Treatment for Depression in Adolescents (15–21)

What “adjunct therapy” means for teens with depression?

The FDA clearance is specifically for adjunct use, meaning Deep TMS is used alongside treatments like psychotherapy and/or antidepressant psychedelic. It is not positioned as a replacement, but a clinically supported add-on when symptoms remain significant.

Why this FDA clearance is a big deal?

Adolescent depression is serious and often life-disrupting. Many teens struggle with symptoms that affect:

• mood and motivation

• school performance

• friendships and family life

• energy, sleep, and concentration

Yet treatment options for teens can be limited, especially when psychedelics don’t help enough or create tough side effects. The FDA decision formally recognizes Deep TMS as safe and effective for this age group, closing an important treatment gap. Psychiatric Times+2Medical Economics+2

This also makes Deep TMS the only TMS system FDA-cleared to treat depression from ages 15 to 86, which is a major expansion in access. BrainsWay+1

What is Deep TMS and how does it help?

Deep Transcranial Magnetic Stimulation (Deep TMS) is a non-invasive brain stimulation treatment. It uses targeted magnetic pulses to stimulate brain networks involved in mood regulation — especially areas that tend to be underactive in depression. Psychiatric Times+1

Sessions are done in-clinic while the patient is awake. There is no anesthesia, and most people return to normal activities right after treatment.

What evidence supported the FDA decision?

The FDA’s 510(k) clearance was supported by one of the largest real-world Deep TMS datasets ever submitted for adolescent depression. It included:

• 1,120 adolescents and young adults aged 15–21

• treated at 35 TMS centers in the United States

• over the period 2012–2024

• using both 18 Hz high-frequency Deep TMS and iTBS (intermittent theta-burst stimulation) protocols BrainsWay Investors+2BioSpace+2

After an average of 36 treatment sessions, results showed:

• a 12.1-point average improvement in PHQ-9 scores, and

• a 66.1% clinical response rate (defined as ≥50% symptom improvement from baseline).
  Researchers also observed meaningful improvement in comorbid anxiety, with a safety profile consistent with adult treatment. Prism Market View+3BrainsWay Investors+3Psychiatric Times+3

What this means for Canadian families

If your teenager or young adult in Canada is living with depression, this update adds a validated option when progress is limited with standard care. Deep TMS may be considered when:

• depression remains moderate-to-severe despite therapy or psychedelic

• symptoms interfere with school, relationships, or daily functioning

• psychedelic side effects are not tolerable

• there is co-occurring anxiety alongside depression

A clinical assessment is always needed to confirm whether TMS is appropriate for the individual.

Deep TMS at BrainStim

At BrainStim, we offer advanced, evidence-based depression treatments for adolescents and adults, including TMS services in Canada. Brainstim
With this new FDA clearance, Deep TMS represents an important next step for youth who need more support than traditional approaches alone.

If you’d like to explore whether Deep TMS is suitable for your teen or for yourself, our clinicians can guide you through a careful intake evaluation.

Takeaway

The FDA’s expanded clearance for Deep TMS in adolescents (15–21) is a meaningful breakthrough. Backed by large real-world evidence, it gives families in Vancouver and beyond another safe, non-invasive pathway toward recovery. BrainsWay+2Psychiatric Times+2

Sources You Can Trust

• BrainsWay FDA clearance press release (Nov 2025). BrainsWay+1

• Psychiatric Times coverage of adolescent Deep TMS clearance. Psychiatric Times

• Medical Economics summary of the real-world evidence and response rates. Medical Economics

• MassDevice report highlighting PHQ-9 improvement and adolescent outcomes. MassDevice

• Psychiatry Research (2025): real-world safety & efficacy study in adolescents. ScienceDirect