Expanded FDA clearance makes Deep TMS available as an adjunct therapy for adolescents aged 15-21 with major depressive disorder (MDD). It comes just two months after the FDA granted expanded clearance to include an accelerated treatment protocol for MDD and patients with comorbid anxiety symptoms.
Deep TMS uses two orthogonal TMS coils placed perpendicular to one another. Operated with a time lag, they induce a circulatory rotating electric field. This results in uniform stimulation of neurons oriented along a wide variety of directions in the targeted brain region. It all takes place within less than a millisecond.
“The FDA’s clearance of this expanded label enables access to Deep TMS for the critically important adolescent patient population, which is often underserved by traditional pharmacological options to manage major depressive disorder,” said Dr. Colleen Hanlon, VP of Medical Affairs, BrainsWay. “The 510(k) clearance was supported by our submission of one of the largest real-world adolescent neuromodulation datasets ever presented to the U.S. FDA, which demonstrated compelling efficacy and safety in reducing depressive symptoms, as well as substantial improvements in comorbid anxiety. This reinforces BrainsWay’s position in the market as the leader of evidence-based, noninvasive treatment for depression across all age groups.”
More about the BrainsWay FDA clearance
The company supported its FDA submission with robust data, including real-world evidence from 1,120 U.S. adolescents between 2012 and 2024. Findings included improvements in the self-administered Patient Health Questionnaire-9 (PHQ-9) rating scale by 12.1 points and a 66.1% response rate. Subjects saw meaningful reductions in anxiety symptoms as well, while safety outcomes remained consistent with adult studies.
Deep TMS is now indicated for the treatment of depressive episodes and for decreasing comorbid anxiety symptoms in adults suffering from MDD who have failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode, and as an adjunct therapy for adolescent patients
“We are excited at the opportunities this clearance can bring, for both the young people suffering from this often debilitating condition, and for their parents who have struggled for so long to find treatment solutions that can bring some joy and hope back into their family life,” said Hadar Levy, BrainsWay CEO. “This clearance will allow us to reach the broadest age range of any TMS system for the treatment of depression. With approximately 5 million adolescents in the U.S. estimated to have experienced a major depressive episode within the past year, this represents a significant milestone for us to be able to address an important segment of the MDD patient population. Clinicians can now treat both adults and adolescents using the same Deep TMS system and established stimulation protocols.”
