BrainsWay receives a go-ahead from FDA for treating depression & anxiety

BrainsWay Ltd., a global medical technology company, has recently announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the firm’s Deep TMS™ H7 Coil for its use in treating adults suffering from depression and other major depressive disorders.

Speaking on the latest development, Christopher von Jako, Ph.D., President & Chief Executive Officer of BrainsWay, stated that this clearance is a breakthrough in BrainsWay’s quest to optimize and refine noninvasive options for treatment of mental health conditions.

Christopher added that clinicians are accustomed to using a variety of pharmaceutical treatments and extending depression clearance to the Deep TMS H7 Coil gives them another effective non-pharmaceutical tool to customize treatment programmes for their patients.

Dr. von Jako further stated that this clearance is the ninth from the FDA and is a testament to the unparallel commitment of BrainsWay to work on ambitious research projects and constantly advance in this field, thereby strengthening its leadership position.

For the record, TMS treatment, like most medical interventions, is not a one-size-fits for all solution considering all anatomical targets: the H1 coil targets a particular region of the brain, and the H7 Coil targets an entirely different region.  The firm sees that inspiring either of these regions can lessen depressive symptoms.

The firm believes that this clearance may innovate its goal of authorizing clinicians to offer more personalized medicine to their patients, considering what works best for them.

As per reliable repots, the clearance from FDA was based on its evaluation of successful results from a double-blind, randomized, controlled multicenter trial conducted on 144 subjects, completed by the Company.

The trial has been intended to better understand the H7 Coil’s effectiveness in tackling treatment-resistant depression. The study found the overall effectiveness of the H7 Coil equivalent to those accomplished with BrainsWay’s H1 Coil.

Additionally, in the following months, BrainsWay plans to implement a training program to train users on making use of the Deep TMS H7 Coil to manage depression following the new FDA clearance.

Source Credit - https://www.globenewswire.com/news-release/2022/08/29/2505888/17676/en/BrainsWay-Receives-New-FDA-Clearance-for-Treating-Depression-and-Anxious-Depression.html