This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
BrainsWay’s Transcranial Magnetic Stimulation (dTMS) is a noninvasive, easy to operate treatment device that has been clinically proven to help alleviate the symptoms of a variety of mental health conditions. It has been FDA-cleared to treat Major Depressive Disorder (MDD) since 2013, and FDA-cleared to treat Obsessive-Compulsive Disorder (OCD) since 2018.
The US Food and Drug Administration (FDA) is a federal agency responsible for, among other tasks, marking which drugs and medical devices are safe to use and considered an effective course of treatment. BrainsWay’s Deep TMS received its FDA clearance status for demonstrating that it is a safe and clinically effective form of therapy for MDD and OCD. dTMS is the first noninvasive medical device to receive an FDA-cleared status for treating OCD.
The FDA clearance status was granted following several clinical trials that found Deep TMS to be well-tolerated and effective: specifically, in 2013 BrainsWay’s Deep TMS therapy was shown to be effective in treating Major Depressive Disorder, granting it FDA clearance for MDD. In 2018, a multicenter randomized trial found BrainsWay’s Deep TMS treatment to be effective in treating Obsessive-Compulsive Disorder, granting the treatment an FDA clearance for OCD.
In addition to receiving a clearance status from the US’s FDA, Deep TMS has received the European CE certification mark, indicating that dTMS was found to conform to the safety, health and environmental standards of products sold within the European Economic Area (EEA).
Deep TMS has received the European CE mark as a sign of its proven ability to alleviate the symptoms of a wide range of mental health conditions. These include MDD, OCD, Alzheimer’s Disease (AD), Autism, Bipolar Disorder, Chronic Pain, Multiple Sclerosis (MS), Parkinson’s Disease, post-stroke rehabilitation, Post-traumatic Stress Disorder (PTSD), the negative symptoms of Schizophrenia, and smoking cessation.
With innovative studies breaking new ground in the field of mental health, Deep TMS shows a great deal of promise to receive approval statuses for additional mental health conditions around the world.