FDA Clears Zeta Surgical’s AI-Powered Robotic TMS Navigation System for Treatment-Resistant Depression

Zeta Surgical’s robotic navigation platform uses AI and computer vision to improve precision and repeatability during transcranial magnetic stimulation procedures. Zeta Surgical has received US Food and Drug Administration (FDA) clearance for its robotic transcranial magnetic stimulation (TMS) navigation system, a technology designed to improve the accuracy and consistency of TMS treatment delivery for patients with treatment-resistant depression (TRD).

The FDA has classified the system as a Class II stereotaxic instrument, allowing it to support clinicians in delivering targeted TMS therapy by automatically tracking patient movement and maintaining accurate positioning of the treatment coil.

The clearance represents another step forward in the use of artificial intelligence (AI), robotics and navigation technologies within neuromodulation, an area of healthcare focused on modifying neural activity to treat neurological and psychiatric conditions.

How Zeta Surgical’s TMS Navigation System Works

Transcranial magnetic stimulation is a non-invasive therapy that uses electromagnetic coils positioned against the scalp to stimulate specific regions of the brain.

The treatment is primarily used for patients with treatment-resistant depression, a severe form of major depressive disorder (MDD) where symptoms do not improve adequately following treatment with at least two antidepressant medications at appropriate doses and durations.

Because TMS relies on stimulating targeted brain regions and neural circuits, accurate positioning of the magnetic coil is an important factor in delivering consistent treatment.

Zeta Surgical’s system uses AI and computer vision technology to monitor patient movement throughout the procedure.

If a patient changes position during treatment, the robotic navigation platform can automatically adjust the coil location to maintain accurate targeting of the intended brain region.

The company said the technology is designed to make TMS delivery more reproducible and easier to integrate into routine clinical workflows.

Improving Precision in Depression Treatment

Historically, one of the challenges associated with TMS has been ensuring consistent targeting between treatment sessions and across different patients.

Zeta Surgical said its platform aims to address this challenge by improving treatment precision and reducing dependence on manual repositioning.

Dr William Gormley, co-founder of Zeta Surgical, said the technology could help expand access to targeted brain therapies by making precise TMS delivery easier to incorporate into clinical practice.

Before receiving FDA clearance, the system’s accuracy and usability were evaluated through collaborations involving Harvard Medical School and the University of Cambridge.

The companies did not disclose specific clinical performance data from these evaluations.

Expanding Role of TMS in Mental Health Care

TMS has become an established treatment option within the mental health sector, particularly for patients with depression who do not respond to conventional therapies.

The first TMS device for major depressive disorder received FDA clearance in 2008, when Neuronetics launched its NeuroStar TMS Therapy System.

Since then, the use of neuromodulation technologies has expanded beyond depression.

TMS is also used in behavioural health conditions including obsessive-compulsive disorder (OCD), while researchers continue to investigate applications in conditions such as post-traumatic stress disorder (PTSD).

Zeta Surgical Expands Medical Navigation Portfolio

The latest FDA clearance follows an earlier regulatory milestone for Zeta Surgical.

In May 2026, the company received FDA clearance for navigation technology used alongside its Bolt and Stylet instruments to support neurosurgical procedures, including external ventricular drain placement and cerebral shunt catheter placement.

The company’s wider technology platform is focused on improving navigation accuracy across neurological procedures.

Growing Market for Neuromodulation Devices

The approval comes as the global neuromodulation market continues to expand.

Neuromodulation technologies are increasingly being applied across neurological and psychiatric disorders, including:

• Deep brain stimulation (DBS) for conditions such as Parkinson’s disease

• Transcranial magnetic stimulation (TMS) for depression and other behavioural health disorders

• Non-invasive stimulation technologies targeting symptoms such as tremors
  

According to GlobalData analysis, the global neuromodulation device market is projected to grow from approximately $6.8bn in 2025 to more than $13bn by 2035.

Increasing demand for personalised therapies, advances in AI-driven medical devices and the need for alternatives to pharmaceutical treatments are expected to support continued innovation in the sector.

What Zeta Surgical’s FDA Clearance Means for the TMS Market

Zeta Surgical’s FDA clearance highlights the growing role of robotics and artificial intelligence in improving the delivery of brain stimulation therapies.

By combining robotic positioning, computer vision and automated movement tracking, the company aims to make TMS treatment more consistent and scalable.

As neuromodulation adoption expands, technologies that improve accuracy, workflow efficiency and patient outcomes are likely to become increasingly important across mental health and neurological care.

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