The FDA has granted 510(k) clearance and a label expansion for a transcranial magnetic stimulation device to treat patients aged 15 to 21 years with major depressive disorder, according to a press release from the manufacturer.
The FDA’s decision clears the way for the BrainsWay Deep TMS system to be utilized as an adjunctive therapy for adolescents and young adults, the company said in the press release.
“This expanded FDA clearance is a great milestone for the field and, more importantly, for the teens and families who have been waiting for additional mental health treatment options,” Colleen Hanlon, PhD, executive vice president of medical affairs at BrainsWay, told Healio.
The current FDA action follows its acceptance of an expanded indication for the device in 2024 to include individuals with MDD aged 22 to 86 years.
With the FDA’s latest approval, the device is indicated for the treatment of depressive episodes and for decreasing comorbid anxiety symptoms in adults with MDD who have failed to achieve satisfactory improvement from previous antidepressant medication treatment.
“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,” BrainsWay CEO Hadar Levy said in the release. “This clearance will allow us to reach the broadest age range of any TMS system for the treatment of depression.”
Clearance was granted following review of data collected from 1,120 adolescents and young adults treated across 35 TMS centers in the United States between 2012 and 2024, which includes administration of both high-frequency (18 Hz) and intermittent theta-burst protocols.
According to data cited in the release, after 36 sessions, participants recorded an average improvement of 12.1 points on the Patient Health Questionnaire-9 scale, as well as a 66.1% response rate, defined as improvement from baseline of 50% or more.
Additionally, patients recorded clinically meaningful reductions in anxiety symptoms via the Generalized Anxiety Disorder-7 scale, consistent with previous studies on adults. Safety outcomes were also consistent with prior adult-population-based clinical trials, per the release.
“Building on previously published research, we now have strong evidence that Deep TMS is both safe and effective for adolescents,” Hanlon told Healio. “This means clinicians can offer a noninvasive, evidence-based therapy at a stage of life when early support can make an enormous difference.”
