Neural Noise

FDA clearance of TMS for youth and shorter adult protocol

2 min read

  • The FDA cleared transcranial magnetic stimulation (TMS) for use in youth 1.
  • A shorter TMS protocol for adults was also cleared; relevant to transcranial stimulation and device regulation 1. 1

Weekly enrichment (2026-07-20)

  • The FDA granted BrainsWay a label expansion for its Deep TMS (H-coil) system as an adjunct therapy for major depressive disorder (MDD) in adolescents aged 15–21, announced November 12, 2025.2
  • The MagVenture TMS Therapy System received a parallel 510(k) clearance (K251125) as an adjunct for MDD in adolescents aged 15–21, delivering standardized protocols such as 10 Hz rTMS or intermittent theta-burst stimulation (iTBS) to the left dorsolateral prefrontal cortex (DLPFC).3
  • Separately, the FDA cleared an accelerated Deep TMS protocol for adult MDD (announced September 16, 2025) that compresses the acute treatment phase to just 6 treatment days.4
  • The accelerated protocol delivers 5 sessions per day for 6 days, then 2 sessions per day once weekly for 4 weeks, with each session lasting under 10 minutes versus 20 minutes in the standard protocol.5
  • Clearance was based on a multicenter, randomized, blinded trial of 104 patients showing the accelerated iTBS protocol had outcomes similar to the standard protocol, without relying on fMRI neuronavigation.5
  • Deep TMS stimulates the left DLPFC via the H-coil; the adult MDD indication also covers decreasing comorbid anxiety symptoms.2 4
  • The accelerated protocol is cleared for adults but not for adolescents; adolescent treatment follows established multi-week stimulation protocols.5 3
  • Context: a post-marketing surveillance study of 1,257 patients aged 11–21 across 56 sites reported HDRS response/remission of 58.3%/48.6% after 30 sessions, rising to 75.0%/58.3% after 36 sessions.6
  • Context: in that cohort the median onset of response was 13 sessions and remission 20 sessions, iTBS (1,800 pulses) and 18 Hz outcomes did not differ significantly, and adverse event rates were comparable to adults.6

Footnotes

  1. https://news.google.com/rss/articles/CBMiqAFBVV95cUxObjZTTHZtLV9mNVJiVkJPd3luQUVLZ2xfZG02b0tyNS1UUllvV0VSaWVEbmktSUNpVlpxVXhzMlBJOExNQWZoNXF5VWdOMXJVWVBjSlMtX3VheVUyS0hfaE9fbXZkZWxfcXhrUUQydDNTVEdmM2RGY3EyX3A5T1VYMzJkLXZPa1pvRHlLNHFaYzIwT1dxTHBHb18xeS10cnItVFdYelRmdmE?oc=5 ↩ ↩2 ↩3

  2. https://www.brainsway.com/news_events/brainsway-receives-fda-clearance-of-deep-tms-as-adjunct-therapy-for-major-depressive-disorder-mdd-in-adolescents-aged-15-to-21/ ↩ ↩2

  3. https://magventure.com/us/fda-clearance-to-expand-tms-therapy-indication-for-adolescents-aged-15-21/ ↩ ↩2

  4. https://www.brainsway.com/news_events/brainsway-receives-fda-clearance-for-accelerated-deep-tms-protocol-for-non-invasive-treatment-of-major-depressive-disorder-mdd/ ↩ ↩2

  5. https://www.psychiatrictimes.com/view/fda-clears-accelerated-protocol-for-deep-tms-to-treat-major-depressive-disorder ↩ ↩2 ↩3

  6. https://doi.org/10.1016/j.psychres.2025.116567 ↩ ↩2

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