August 20, 2021
1 minute read
The FDA has granted 510 (k) clearance to BrainsWay for its non-invasive deep transcranial magnetic stimulation system to treat symptoms of comorbid anxiety in adults with depression, according to a press release.
This authorization allows BrainsWay to market the system to patients with major depressive disorder and anxiety symptoms who have experienced below-average improvement from antidepressant drugs.
“Many patients with major depression show symptoms of anxiety,” said the president and CEO of BrainsWay. Christopher von Jako, PhD, said in the statement. “This most recent regulatory achievement reinforces BrainsWay’s leadership position at the forefront of delivering transformative solutions to advance patient well-being.
According to the release, data from 11 studies on 573 patients have been presented to the FDA, showing that treatment with deep transcranial magnetic stimulation (TMS) had “favorable results” compared to drugs or dummy treatments.
“This clearance is confirmation of what many have anecdotally believed for years – that Deep TMS is a unique form of therapy that can treat symptoms of comorbid anxiety using the same depression treatment protocol,” Aron Tendler, MDBrainsWay chief medical officer said in the statement. “We look forward to continuing to work with our providers to provide the best possible care for patients who have come to rely on BrainsWay’s deeper and broader neurostimulation and our revolutionary approach to treating mental health disorders. “