FDA clears TMS treatment for MDD

BrainsWay Ltd. announced it has received 510(k) clearance from the FDA for its Deep TMS H7 Coil for use in treating adults with major depressive disorder, as well as comorbid anxiety.

A 510(k) clearance is a technical dossier required by the FDA to sell a medical device in the United States.

“This clearance is a significant milestone in BrainsWay’s pursuit of refining and optimizing noninvasive options for treatment-resistant mental health conditions,” BrainsWay President and CEO Christopher von Jako, PhD, said in a company release. “Clinicians are accustomed to having myriad pharmaceutical options to tailor treatment plans for their patients, and expanding depression clearance to the Deep TMS H7 Coil provides them with another powerful nonpharmaceutical tool.”

BrainsWay’s Deep TMS product was cleared to treat obsessive compulsive disorder in 2018, according to the release. With the new clearance, there is no need to upgrade or add software to the systems that are currently installed.

“Similar to most medical interventions, TMS treatment for depression is not a one-size-fits-all solution with respect to all anatomical targets; the H1 Coil targets one region of the brain, and the H7 Coil targets a different region, and we now see that stimulating either of these regions can mitigate depressive symptoms,” Jako said in the release. “We believe that this clearance may advance our goal of enabling clinicians to provide more personalized medicine for their patients depending upon what works best for them.”

The FDA’s clearance was based off of its review of successful results from a randomized, double-blind, controlled, multicenter study. The trial was designed to test the H7 Coil’s efficacy in treating treatment-resistant depression. The study reported findings similar to those achieved with the H1 Coil, according to the release.

BrainsWay said it will be implementing a training program in the coming months to educate physicians on using the Deep TMS H7 Coil for depression treatment.