This is BrainsWay’s global website. The global website is not intended for persons in the United States and includes information on clinical indications that were not cleared by the FDA, which are subject to further US regulatory review for safety and efficacy. BrainsWay is cleared by the FDA only for patients with MDD who failed to respond to one or more anti-depressants in the current episode, and for patients with OCD as an adjunct treatment.
With the FDA approval of BrainsWay back in August 2018, the company has seen significant growth ever since then. Some statistics reveal that the company had shipped 57 OCD coils to new clinics or upgraded its existing customers. At the end of 2018, there are 383 Deep TMS systems in the United States representing a 47% increase in machines and revenue dating back to last year.