BrainsWay Ltd. announced on September 16, 2025, that it received FDA clearance for its accelerated Deep TMS protocol for the non-invasive treatment of Major Depressive Disorder (MDD). This regulatory approval is a significant milestone, making the accelerated protocol commercially available in the United States. The clearance expands patient and provider access to an improved treatment option.
Clinical data demonstrated that BrainsWay’s new accelerated stimulation protocol is comparable to the standard Deep TMS protocol in terms of depression score improvement, response rates, and remission rates. This accelerated approach offers a significantly shorter acute treatment phase, which can enhance convenience and appeal for patients. The FDA clearance validates the efficacy and safety of this novel protocol.
The commercial availability of this accelerated protocol is expected to drive further adoption of Deep TMS therapy. This development strengthens BrainsWay's leadership in advanced neurostimulation treatments for mental health disorders. It also underscores the company's commitment to innovation and expanding treatment possibilities for MDD patients.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.