On August 18th, BrainsWay announced that it had received approval from the FDA to market its Deep TMS™ device used for the treatment of anxious depression.
“This clearance expands upon BrainsWay’s depression indication, and represents yet another in a series of firsts for the Company,” said Christopher von Jako, Ph.D., President and Chief Executive Officer of BrainsWay. “Many patients suffering from major depression experience anxiety symptoms. This most recent regulatory achievement further establishes BrainsWay’s leadership position at the forefront of bringing transformative solutions to advance patient wellness.”
BrainsWay is a medical technology company that is focused on the development of novel devices that can advance the quality of patient treatment options. Their flagship technology, the Deep Transcranial Magnetic Stimulation, or Deep TMS™, is offering expanded treatment options in the field of mental health that was previously thought impossible.
The noninvasive treatment has been tested and proven to have positive impact on conditions like depression, OCD, and addiction thanks to its ability to directly and deeply stimulate broad areas of the brain. Multiple studies have proven its results and is being used by growing numbers of healthcare professionals and their patients.
Anxiety symptoms are common in those suffering from major depressive disorder with 60-90% of patients experiencing moderate anxiety and 20-25% experiencing more severe anxiousness. Nervousness, panic, elevated heart rate, shortness of breath, sweating, insomnia, trembling, and loss of focus are all commonly occurring symptoms. Even before the social upheaval of COVID-19, the economic burden of major depressive order in the US was $326 billion.
The FDA approval means that BrainsWay’s Deep TMS System can be marketed for the treatment of depressive episodes and anxiety symptoms, a much needed option for adult patients suffering from major depressive disorder who haven’t seen success with other treatment options.