Zeta Surgical Wins FDA 510(k) Nod for Robotic TMS Navigation System

Boston-based Zeta Surgical said its Zeta TMS Robotic System has received FDA 510(k) clearance, bringing operating-room-level robotic accuracy to depression, OCD and addiction TMS clinics.

Key Takeaways

  • Zeta Surgical received FDA 510(k) clearance (K261471) on July 10 for its Zeta TMS Robotic System, its second cranial navigation clearance of 2026.
  • The Class II stereotaxic device robotically positions TMS coils using 3D patient imaging, tracking head movement 20 times per second with under 1 mm positional and under 1 degree angular accuracy, without cranial pins or general anesthesia.
  • The system targets TMS clinics treating depression, OCD, PTSD and addiction, replacing the freehand coil placement many clinics still use.
  • It sets up in under a minute and fits ambulatory surgical centers, psychiatric clinics and academic hospitals without changing existing TMS workflows; deployment has already begun at HOPE Therapeutics clinics in West Palm Beach and Sarasota.
  • Accuracy and usability testing was conducted with Harvard Medical School and the University of Cambridge, building on Zeta's May 2026 frameless cranial navigation clearance.

Zeta Surgical Wins FDA 510(k) Nod for Robotic TMS Navigation System

Boston-based Zeta Surgical said on July 10 that its Zeta TMS Robotic System has received U.S. Food and Drug Administration 510(k) clearance, giving the company its second cranial navigation clearance of 2026 and bringing operating-room-level robotic accuracy into transcranial magnetic stimulation (TMS) clinics for the first time.

What The Clearance Covers

The device (K261471) is classified as a Class II stereotaxic instrument under 21 CFR 882.4560 with product codes SGE and QFF, meaning it can be used as an image-guidance system for accurate positioning of TMS treatment coils on planned brain targets using 3D patient imaging. Zeta says the robotic head continuously tracks patient movement 20 times per second and adjusts the coil in real time, delivering less than 1 mm positional accuracy and less than 1 degree of angular accuracy without cranial pins or general anesthesia.

Zeta TMS Robotic System close-up rendering

Why Robotic TMS Matters

TMS is a non-invasive therapy already used to treat approximately one-third of major depressive disorder patients whose disease is resistant to medication, and is expanding into OCD, PTSD and addiction disorders. Precise, repeatable targeting is a known bottleneck, and today many clinics still rely on freehand coil placement. Accuracy and usability testing for the Zeta TMS Robotic System was carried out with Harvard Medical School and the University of Cambridge, and the system builds on Zeta's own May 2026 clearance for its underlying frameless cranial navigation platform.

A Rapid-Deploy System For Outpatient Clinics

Zeta says the robot can be set up in under a minute and is designed to slot into ambulatory surgical centers, psychiatric clinics and academic hospitals without changing existing TMS workflows. "This clearance brings operating-room-level navigation and robotic accuracy into a platform that can be rapidly deployed in virtually any clinic," said William Gormley, co-founder of Zeta and a neurosurgeon at Mass General Brigham, adding that the system should help expand access to targeted brain therapies. The company had already begun commercial deployment of its underlying TMS navigation system at HOPE Therapeutics clinics in West Palm Beach and Sarasota earlier this year.

Field Positioning

The clearance widens the surgical-robotics field beyond the abdominal and orthopedic domains dominated by Viz.ai and Cortechs.ai partnerships and by systems such as CMR Surgical's Versius Plus, and pushes AI-guided robotics into non-invasive brain therapy. It is the second FDA 510(k) that Zeta has secured this year, following its May 2026 nod for cranial navigation, brain biopsy and EVD placement instruments.

Reporting based on coverage from Surgical Robotics Technology, PR Newswire and Zeta Surgical.

Category: Medical Robotics

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Frequently Asked Questions

What did the FDA clear Zeta Surgical's system to do?

The 510(k) clearance (K261471) covers the Zeta TMS Robotic System as an image-guidance system for accurately positioning TMS treatment coils on planned brain targets using 3D patient imaging. It is classified as a Class II stereotaxic instrument under 21 CFR 882.4560 with product codes SGE and QFF.

How accurate is the Zeta TMS Robotic System?

The robotic head tracks patient movement 20 times per second and adjusts the coil in real time, delivering under 1 mm positional accuracy and under 1 degree angular accuracy, without cranial pins or general anesthesia.

Which conditions is robotic TMS intended to treat?

TMS is used for medication-resistant major depressive disorder, affecting roughly one-third of MDD patients, and is expanding into OCD, PTSD and addiction disorders.

Where is the system already being deployed?

Zeta had begun commercial deployment of its underlying TMS navigation system earlier this year at HOPE Therapeutics clinics in West Palm Beach and Sarasota, Florida.