FDA Clears Robotic System for Precise TMS Coil Positioning

Transcranial magnetic stimulation (TMS) is a noninvasive therapy used primarily for treatment-resistant depression and increasingly applied to other behavioral health conditions. Because TMS targets specific brain regions and neural circuits, accurate, repeatable coil placement is essential for consistent outcomes across sessions and care settings. Patient motion can disrupt targeting and workflow. A new system now offers real-time robotic coil positioning with automatic motion compensation to help maintain on-target stimulation.

ZETA SURGICAL’s (Boston, MA, USA) Zeta TMS Robotic System has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The device is classified as a Class II stereotaxic instrument under 21 CFR 882.4560 with product codes SGE and QFF (K261471). Designed to support precise and repeatable treatment delivery across clinical settings, the platform combines real-time navigation, robotic positioning, and automatic motion compensation.

The system provides real-time robotic positioning of transcranial magnetic stimulation (TMS) coils with submillimeter‑level accuracy. It dynamically tracks patient movement throughout treatment and automatically adjusts the coil position to help maintain on‑target delivery. For rapid clinical deployment, setup can be completed in under a minute and used across virtually any point‑of‑care environment.

Accuracy and usability testing was conducted in collaboration with Harvard Medical School and the University of Cambridge. The motion‑compensation approach is intended to preserve target alignment even when patients move during a session. The configuration is described as suitable for deployment across a range of clinical settings.

“The Zeta TMS Robotic System builds on the real-time image guidance already trusted in our TMS deployments. It uses that same guidance to dynamically adjust position throughout a session, without asking clinics to change how they already work. We designed this to make accurate care easier to deliver, session after session,” said Benjamin Lee, Chief Product Officer of ZETA.

“This clearance brings operating-room-level navigation and robotic accuracy into a platform that can be rapidly deployed in virtually any clinic. By making precise and repeatable TMS delivery easier to integrate into routine clinical care, we believe the system can help expand access to advanced, targeted brain therapies for patients across the country,” said William Gormley, MD, MBA, MPH, Co-Founder of ZETA and a neurosurgeon at Mass General Brigham.

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