BrainsWay (BWAY +21.1%) has received FDA 510(k) clearance for its deep transcranial magnetic stimulation (Deep TMS) system for use as an aid in short-term smoking cessation in adults.
The company expects to execute a controlled U.S. market release of its H4 Deep TMS coil for this indication early next year.
The company says that this is the first FDA nod in the addiction space for any TMS device. It represents BrainsWay’s third FDA-cleared coil and indication, following clearance of its H1-coil for major depressive disorder (MDD) and the H7-coil as an adjunct therapy for the treatment of obsessive-compulsive disorder (OCD).
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