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Jul 12, 20260 views2 min read

FDA Clears Robotic TMS System for Treatment-Resistant Depression

The FDA granted 510(k) clearance on July 10, 2026, to the ZETA TMS Robotic System, a device that uses image-guided robotics to position magnetic stimulation coils on the brain with submillimeter accuracy. The system was validated in collaboration with Harvard Medical School and the University of Cambridge.

FDA Clears Robotic TMS System for Treatment-Resistant Depression
Source:Business Wire

The FDA granted 510(k) clearance on July 10, 2026, to the ZETA TMS Robotic System, a device that uses image-guided robotics to position magnetic stimulation coils on the brain with submillimeter accuracy.

ZETA SURGICAL, the company behind the device, said the system is designed to treat conditions including treatment-resistant major depressive disorder, PTSD, addiction, and obsessive-compulsive disorder. The clearance was issued under classification 21 CFR 882.4560.

Transcranial magnetic stimulation, or TMS, uses magnetic fields to stimulate nerve cells in the brain. It is a non-invasive procedure that has been used for years to treat depression in patients who have not responded to medication. The ZETA system adds robotic precision to the process, automatically adjusting the coil position in real time as the patient moves during treatment.

The company says the system can be set up in under one minute, making it practical for use in a variety of clinical settings. Accuracy and usability testing were conducted in collaboration with Harvard Medical School and the University of Cambridge.

The clearance follows an earlier 510(k) approval in October 2025 for ZETA's navigation system, which provided image-guided positioning without the robotic automation component. The new robotic system builds on that platform by adding motion-aware tracking.

Mental health advocates say the clearance is a positive step for patients who have exhausted other treatment options. Treatment-resistant depression affects an estimated 30 percent of people diagnosed with major depressive disorder, and access to effective alternatives to medication remains limited in many parts of the country.

The ZETA TMS Robotic System is expected to be available at select clinical sites in the coming months as the company scales up production and training.

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