BrainsWay introduced that the US Meals and Drug Administration (FDA) has granted a label growth for the deep transcranial magnetic stimulation (Deep TMS) system that makes the remedy obtainable as an adjunct remedy for adolescents aged 15 to 21 years who’ve main depressive dysfunction (MDD).1 Earlier than this approval, Deep TMS was solely indicated for sufferers with MDD aged 22 to 86 years.2
“The FDA’s clearance of this expanded label allows entry to Deep TMS for the critically vital adolescent affected person inhabitants, which is usually underserved by conventional pharmacological choices to handle main depressive dysfunction,” mentioned Colleen Hanlon, PhD, the vice chairman of medical affairs at BrainsWay.
The FDA offered 510(ok) clearance following BrainsWay’s submission of a strong knowledge set, together with real-world proof collected from 1120 adolescents (aged 15-21) handled throughout 35 TMS facilities within the US between the years 2012 and 2024. Information from high-frequency (18 Hz) and intermittent theta-burst Deep TMS protocols had been included. The Deep TMS process gives sufferers with noninvasive magnetic stimulation via a cushioned helmet to induce electrical currents in localized areas of the prefrontal cortex. As measured by the self-administered Affected person Well being Questionnaire-9 ranking scale, the outcomes demonstrated that, following 36 remedy classes, adolescent sufferers noticed a median enchancment of 12.1 factors and a 66.1% response charge (outlined as an enchancment from baseline of fifty% or larger). Investigators additionally famous significant reductions in anxiousness signs as measured by the self-administered Generalized Anxiousness Dysfunction scale, in keeping with prior grownup research. As to security profile, outcomes had been in keeping with earlier grownup research.
“The 510(ok) clearance was supported by our submission of one of many largest real-world adolescent neuromodulation datasets ever introduced to the US FDA, which demonstrated compelling efficacy and security in lowering depressive signs, in addition to substantial enhancements in comorbid anxiousness. This reinforces BrainsWay’s place available in the market because the chief of evidence-based, noninvasive remedy for melancholy throughout all age teams,” mentioned Hanlon.
The BrainsWay Deep TMS System is now obtainable for the remedy of depressive episodes and comorbid anxiousness signs in adults with MDD who’ve failed to realize passable response from earlier antidepressant medicine remedy within the present episode, and as an adjunct remedy for adolescent sufferers aged 15-21.
“We’re excited on the alternatives this clearance can carry, for each the younger folks affected by this usually debilitating situation, and for his or her dad and mom who’ve struggled for therefore lengthy to seek out remedy options that may carry some pleasure and hope again into their household life,” mentioned Hadar Levy, the chief government officer of BrainsWay. “This clearance will enable us to succeed in the broadest age vary of any TMS system for the remedy of melancholy. With roughly 5 million adolescents within the US estimated to have skilled a significant depressive episode inside the previous 12 months, this represents a major milestone for us to have the ability to deal with an vital section of the MDD affected person inhabitants. Clinicians can now deal with each adults and adolescents utilizing the identical Deep TMS system and established stimulation protocols.”
References
1. BrainsWay receives FDA clearance of deep TMS™ as adjunct remedy for main depressive dysfunction (MDD) in adolescents aged 15 to 21. Information launch. November 13, 2025. Accessed November 14, 2025.
2. BrainsWay receives FDA clearance for accelerated deep TMS protocol for non-invasive remedy of main depressive dysfunction (MDD). Information launch. September 16, 2025. Accessed November 14, 2025.