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.
BrainsWay Deep TMS therapy has been tested in over 60 clinical studies, for various clinical indications, in leading institutions worldwide. The FDA has cleared BrainsWay Deep TMS therapy for treatment resistant depression and it is currently available in the U.S., Europe, and South America.
BrainsWay is also indicated by the FDA as an intended adjunct treatment for adult patients suffering from Obsessive Compulsive Disorder (OCD)/FDA De Novo.