FDA Clears Accelerated Protocol for Deep TMS to Treat Major Depressive Disorder

Design Stock/Adobe Stock

The US Food and Drug Administration (FDA) has granted expansion of the currently cleared treatment protocols for BrainsWay’s deep transcranial magnetic stimulation (deep TMS).¹ The new expansion will include accelerated protocol for patients with major depressive disorder (MDD), including patients with comorbid symptoms of anxiety.

The FDA’s expanded clearance decision was based on data from a multicenter, randomized, blinded study which showed accelerated deep TMS protocol with intermittent theta burst stimulation had similar outcomes to standard protocols in treating patients with MDD. The new protocol also required fewer visits to administration sites for patients, as the standard requires once-daily administration. This trial included 104 patients diagnosed with depression, making it the largest randomized, controlled, blinded, multicenter trial of accelerated deep TMS protocol.² The study also did not rely on neuronavigation equipment like fMRI.²

The accelerated Deep TMS group compared with the standard Deep TMS group had comparable measures of depression scores and response and remission rates. From the Hamilton Depression Rating Scale, scores were reduced by 19.02 points in the accelerated group and 19.79 points in the standard group.¹ Response and remission rates were 87.8% and 78% for the accelerated group, and 87.5% and 87.5% for the standard group.¹ The median time to remission was 21 days in the accelerated group and 28 days for the standard group.¹ No severe adverse events were reported in this study, indicating overall safety of the procedure.

The accelerated protocol included an initial acute phase of 5 TMS administration sessions per day for 6 days, then 2 sessions per day once a week for 4 weeks. Each session lasted less than 10 minutes in the accelerated protocol. The standard protocol included an acute phase of 5 daily sessions over the course of 4 weeks, then 2 sessions per day for 2 weeks. In the standard protocol, each session lasted 20 minutes.

Hadar Levy, BrainsWay's chief executive officer said in a press release, "more than just another clearance, this marks a pivotal advancement in the treatment of depression with deep TMS because it expands the ways in which we can use deep TMS to treat depression. While previously, treatment involved 4 weeks of daily treatment sessions before follow up visits, this newly cleared accelerated protocol includes an acute phase of just 6 treatment days."

Deep TMS, BrainsWay’s TMS system, is currently indicated to treat depressive episodes and decrease comorbid anxiety symptoms. It is intended to treat adult patients with MDD who have not attained improvement from prior medication treatment. The treatment is non-invasive.

"As we look toward introducing the accelerated protocol to patients, we will be providing training to healthcare providers over the coming months. In addition, we are actively seeking updates to reimbursement to match the new accelerated protocol, which will help with patient adoption,” added Levy.

References

1. BrainsWay receives FDA clearance for accelerated Deep TMS protocol for non-invasice treatment of major depressive disorder. Press release. September 16, 2025. Accessed September 16, 2025. https://www.benzinga.com/pressreleases/25/09/g47688560/brainsway-receives-fda-clearance-for-accelerated-deep-tms-protocol-for-non-invasive-treatment-of-m

2. BrainsWay reports positive results from multicenter randomized study of accelerated Deep TMS for major depressive disorder (MDD). Press release. June 11, 2025. Accessed September 16, 2025. https://investors.brainsway.com/news-releases/news-release-details/brainsway-reports-positive-results-multicenter-randomized-study