BrainsWay’s Deep TMS H7 Coil Gets Expanded 510(k) Clearance

BrainsWay has received an expanded 510(k) clearance for its Deep TMS H7 Coil for treatment of adults with major depressive disorder and depression, including depression with anxiety symptoms.

The transcranial magnetic stimulation (TMS) device, which is also cleared to treat obsessive-compulsive disorder, includes a cushioned and cooled helmet to deliver the noninvasive treatment, which stimulates nerve cells in the brain using a series of repetitive electromagnetic pulses.

The device targets a different region of the brain than the company’s H1 Coil tool, offering another option for patients who do not respond to the H1 Coil treatment.

The FDA clearance was based on results from a trial that demonstrated the H7 Coil’s comparable efficacy to the H1 Coil.