Brainsway has gained US marketing rights for its Deep transcranial magnetic stimulation (TMS) device, designed for use in patients with depression, who have failed to respond to antidepressant medications, following the US Food and Drug Administration's (FDA) approval.
The noninvasive device places an electromagnetic coil adjacent to a patient’s scalp to provide brief magnetic pulses to the brain and induce an electric field in the underlying brain tissue.
Brainsway chief scientist Dr Yiftach Roth said, "The safety and efficacy of depression therapy with Brainsway’s device have been demonstrated extensively, and patients now have the option of receiving comfortable, noninvasive treatment without the need for anesthesia or hospitalization, and without any significant side effects that might affect their quality of life."
Brainsway CEO Uzi Sofer said the FDA clearance demonstrates that the noninvasive device is both safe and effective.
"I believe this approval will boost awareness and acceptance of Brainsway’s Deep TMS technology not only in the U.S., but the world over, as we continue to also work towards achieving regulatory approval from healthcare authorities in Canada and other countries," Sofer added.
"CNS is a difficult and challenging field and few companies have any projects in their pipelines in this field.
"We have dozens of products ready to be released, and we hope to obtain clearance for these in the future."