BrainsWay Granted Clearance for Deep TMS Stimulator

The FDA awarded BrainsWay 510(k) clearance for its new stimulator, which will be integrated into the BrainsWay deep transcranial magnetic stimulation system for treating major depressive disorder.

The device is designed for use with the company’s proprietary H-Coil helmet in treating MDD. It includes new features that increase physician ease of use and improve energy efficiency.

The stimulator also provides a patient management system with a depression treatment protocol and a tool for motor threshold detection.