BrainsWay Receives FDA Clearance Of Next Generation Stimulator,

(RTTNews) - BrainsWay Ltd., the parent company of BrainsWay USA, Inc., said that it has received U.S. Food and Drug Administration 510(k) clearance for its new stimulator to be integrated into BrainsWay's Deep Transcranial Magnetic Stimulation or Deep TMS System for the treatment of Major Depressive Disorder or MDD.

BrainsWay's next-generation stimulator enhances the complete Deep TMS system and streamlines treatment for physicians and their patients. It is the most advanced stimulator in its class and custom-designed with the Company's proprietary H-Coil helmet for the treatment of MDD. BrainsWay's Deep TMS proprietary H-Coil technology reaches deeper and larger surface areas of the brain than standard TMS treatments.

The new stimulator provides enhanced features focused on increasing the ease of use for the physician, integrating enhanced energy utilization, a patient management system with the built-in depression treatment protocol and a user-friendly tool for accurate, rapid motor threshold detection. These features will decrease set up time and increase office efficiencies.