Regulatory status
- In the United States, BrainsWay Deep TMS has FDA clearances for specific indications, including MDD, OCD, smoking cessation, and anxious depression.
- BrainsWay reports European CE marking for several conditions, including bipolar disorder, PTSD, and schizophrenia (negative symptoms).
- CE marking is not FDA clearance. Those CE-marked indications are not FDA-cleared for treatment in the United States.