06 · Newest Clearance

Adolescent & Young Adult Depression

For teens and young adults whose depression has not improved with therapy or medication.

H1BrainsWay coil
adjunctive (BrainsWay H1, November 2025 — ages 15–21)Clearance

In November 2025 the FDA cleared BrainsWay's H1 coil as an adjunctive treatment for adolescent depression in ages 15–21. With the existing adult clearances, BrainsWay is the only single TMS device formally cleared across the uninterrupted age range 15–86.

The clearance rests primarily on real-world evidence rather than a sham-controlled RCT of the H1 coil in this age group — a fact we disclose openly to families. Two prior figure-8 sham-controlled RCTs in adolescents were negative; five others were positive. The deep-TMS-specific evidence is the 1,120-patient real-world cohort.

FDA status

FDA-cleared adjunctive (BrainsWay H1, November 2025 — ages 15–21)

Standard protocol at IPMG TMS

Adjunctive · 30–36 sessions · H1, 18 Hz or iTBS · informed-consent process with family

  • 66% response · PHQ-9 ↓ 12.1 points
    Real-world cohort of 1,120 adolescents (ages 15–21) across 35 US TMS centers, 36 sessions.
    Roth et al., Psychiatry Research 2025
  • ~4% discontinuation
    Lower than in adult cohorts. Safety profile equivalent to adults.
Eligibility

Who this is for.

  • Adolescents and young adults 15–21 with MDD
  • Patients receiving concurrent therapy or medication who need more
  • Families seeking an option without systemic medication exposure

Eligibility is finalized at consultation. We screen carefully for contraindications — see the Safety page.

Talk with the IPMG TMS team.

A consultation is the right next step. We will review your prior treatments, confirm whether you meet the FDA-cleared criteria for this indication, and walk you through what your insurance covers.