MagVenture Receives FDA Clearance for Accelerated TMS Protocols, Expanding Flexibility for Clinics and Patients

ALPHARETTA, GA, UNITED STATES, May 26, 2026 /EINPresswire.com/ -- MagVenture^®, a global leader in non-invasive neuromodulation technology, today announced that the U.S. Food and Drug Administration (FDA) has granted clearance for an expanded indication of its MagVenture TMS Therapy^® system to include accelerated transcranial magnetic stimulation (aTMS) protocols for the treatment of Major Depressive Disorder (MDD) in adult patients.

This clearance introduces a more flexible treatment paradigm—enabling clinicians to deliver multiple TMS sessions per day over a condensed schedule, while maintaining the same trusted safety and effectiveness profile as conventional once-daily TMS therapy. Accelerated protocols, in which multiple TMS sessions (≥2) are administered per day, allow treatment to be completed in days rather than weeks, offering new opportunities to align care delivery with both clinic workflows and patient needs.

Unlike traditional TMS schedules, which typically involve one session per day over several weeks, accelerated TMS allows for multiple sessions per day—ranging from 2 to 10 sessions daily based on clinical judgment and patient needs—significantly reducing overall treatment duration. This advancement supports greater access to care by enabling clinics to treat more patients efficiently, while also offering patients a shorter, more adaptable treatment experience.

Importantly, this clearance allows accelerated TMS protocols to be delivered with or without MRI-based neuronavigation, providing clinicians with greater flexibility in how they implement treatment based on their clinical setup and patient preferences.

The expanded indication includes accelerated protocols for both repetitive TMS (rTMS) and intermittent theta-burst stimulation (iTBS), in addition to the existing standard once-daily regimens. The clearance is based on established MagVenture TMS Therapy^® technology and does not require changes to the system hardware, stimulation output, waveform, or safety architecture.

“The evidence base for accelerated TMS in major depression has matured rapidly, and this clearance translates that evidence into broader clinical use. The flexibility to deliver multiple sessions per day, with or without neuronavigation, allows clinicians to tailor protocols to the patient in front of them rather than to a fixed schedule,” said Andre R. Brunoni, Sherry Gold Knopf Crasilneck Distinguished Chair of Psychiatry at UT Southwestern Medical Center and Head of the Division of Interventional Psychiatry in the same institution.

MagVenture’s accelerated protocols are built upon established TMS technology and clinical evidence, utilizing both repetitive TMS (rTMS) and intermittent theta burst stimulation (iTBS) approaches. These protocols maintain the same fundamental mechanism of action—stimulating targeted brain regions such as the left dorsolateral prefrontal cortex (DLPFC)—while optimizing treatment delivery through increased session frequency.

Accelerated TMS represents an evolution of established TMS therapy, supported by more than two decades of clinical research progressing from once-daily treatment schedules to increasingly time-efficient, multi-session protocols. This body of work has consistently demonstrated the feasibility and tolerability of delivering multiple sessions per day within established safety parameters.

In clinical practice, these protocols typically rely on well-established targeting approaches, including scalp-based methods such as Beam F3 or the 5.5-cm rule, which provide reliable localization of the DLPFC without requiring advanced imaging. While neuronavigation and connectivity-based targeting may be used in certain settings, standard targeting approaches remain widely used and clinically appropriate for routine care.

Clinical data and regulatory review confirm that accelerated TMS protocols operate within established safety and effectiveness parameters, with outcomes comparable to standard once-daily treatment schedules and no increase in adverse events.

This milestone reflects MagVenture’s ongoing commitment to innovation and its mission to expand access to effective, non-invasive treatment options. By enabling more efficient care delivery and reducing the time burden on patients, accelerated TMS has the potential to reach more individuals in need—helping bridge gaps in mental health care and improving outcomes at scale, in line with the company’s mission to expand access to magnetic stimulation worldwide.

MagVenture TMS Therapy^® systems are widely used across academic institutions, private practices, and hospital networks worldwide, known for their reliability and adaptability. The addition of accelerated protocols further enhances the system’s versatility, empowering clinicians to tailor treatment plans to real-world clinical and patient demands.

MagVenture will be exhibiting at the annual Clinical TMS Society meeting, June 4-6, in Boston.

Lauren Schultheiss
MagVenture
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