The FDA cleared an updated deep transcranial magnetic stimulation protocol for adult smoking cessation that reduces the standard course from six weeks to three. The clearance applies to BrainsWay's existing H4 coil indication and is based on data showing equivalent four-week continuous abstinence rates with the shorter course.
The original 2020 clearance required 18 sessions over six weeks. The updated protocol delivers 15 sessions over three weeks. Continuous abstinence at four weeks post-treatment was 28% under the new protocol versus 27% under the prior protocol in a comparison cohort of 250 patients.
The shorter protocol is expected to improve completion rates, which had been a limiting factor in real-world effectiveness. It also reduces total cost of treatment, though insurance coverage for smoking cessation TMS remains limited.
The CDC's Office on Smoking and Health welcomed the change, noting that any reduction in treatment burden is likely to increase population-level smoking cessation. TMS remains a third-line option after first-line nicotine replacement and varenicline, but is increasingly used in patients who have failed those options.
Source
Reporting based on coverage from FDA Newsroom. This article is editorial summary intended for general information; it is not medical advice.