The US Food and Drug Administration (FDA) has approved Brainsway’s Deep transcranial magnetic stimulation (TMS) device for use in patients with depression who have failed to respond to antidepressant medications.
Using an electromagnetic coil placed adjacent to a patient’s scalp, the noninvasive device applies brief magnetic pulses to the brain which 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 hospitalisation, 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 US, but the world over, as we continue to also work towards achieving regulatory approval from healthcare authorities in Canada and other countries," Sofer said.
"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."
In addition to depression, the device is indicated for use in patients with schizophrenia, obesity, eating disorders, Parkinson’s disease, Alzheimer’s disease, autism and post-traumatic stress disorder, according to the company.
