FDA clears first brain stimulation device to help smokers quit

FDA granted marketing approval for BrainsWay’s smoking cessation system that uses deep transcranial magnetic stimulation (TMS) and H4-coil technologies. The system was analyzed in a prospective, double-blind, randomized, multicenter study comprising 262 adults with a history of smoking an average of more than 26 years and who unsuccessfully tried quitting. Active and sham treatments were performed every day 5 days a week for 3 weeks, followed by three additional sessions once weekly for 3 weeks, for a total of 18 sessions over 6 weeks. Among participants who completed the study, the continuous quit rate was 28.4% in the active deep TMS group, compared with 11.7% in the sham treatment group. The average number of cigarettes smoked per day was statistically significantly lower in the active deep TMS group compared with the sham treatment group. The most common adverse events were headache, discomfort at the application site, back pain, and muscle twitching. BrainsWay expects to launch a “controlled” U.S. market release of the system in early 2021.