FDA Clears First Brain Stimulation Device to Help Smokers Quit

[Anderson]

The US Food and Drug Administration (FDA) has granted marketing approval for the BrainsWay deep transcranial magnetic stimulation (TMS) system to help adult smokers kick tobacco. This is the company's third FDA-approved indication for its deep TMS system and the first FDA approval for any TMS device for addiction, the company said in a press release. As previously reported, the system has already been approved by the FDA as a treatment for patients suffering from obsessive-compulsive disorder and major depressive disorder. The BrainsWay deep TMS system with H4-coil is designed to target addiction-related brain circuits.

[Pauline]

@anderson Among participants who completed the study ― ie, those who underwent treatment for 4 weeks, kept daily records, and for whom confirmatory urine samples were available – the CQR was 28.4% in the active deep TMS group, compared to 11.7% in the sham treatment group (P = .0063).