BrainsWay said it has won de novo clearance from the FDA for its deep transcranial magnetic stimulation (Deep TMS) system for treatment of obsessive-compulsive disorder (OCD) in adults.
The clearance marks the second indication granted for BrainsWay Deep TMS, and the first noninvasive medical device clearance for the treatment of OCD. The FDA cleared the device for treatment of major depressive disorder (MDD) in 2013. Deep TMS treatment is non-invasive, requires no anesthesia and has been demonstrated to be safe and well-tolerated, according to a statement by the Jerusalem, Israel-based company.
BrainsWay’s H7- coil targets the anterior cingulate cortex, a region known for many years to be centrally implicated in the pathophysiology of OCD, according to Abraham Zangen, a scientific founder and a neurobiological consultant to the company. BrainsWay uses a different coil, the H-1 coil, to treat depression by targeting the lateral pre-frontal cortex.