Zeta Surgical’s AI-Powered TMS Navigation System Gains FDA 510(k) Clearance
Boston-based Zeta Surgical has announced that its Zeta TMS Navigation System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). Classified as a Class II stereotaxic instrument under product codes SGE and QFF (K251927), the system enables image-guided, real-time coil positioning for transcranial magnetic stimulation (TMS). This clearance represents a significant regulatory milestone for navigated TMS systems, particularly as it is believed to be the first device cleared under the SGE product code.
The Zeta TMS Navigation System integrates 3D imaging and motion-aware tracking technology to maintain coil alignment even as patients move, helping clinicians achieve precise targeting during treatment. TMS is widely used in neuropsychiatry, most notably for treatment-resistant major depressive disorder (TR-MDD), which affects roughly one-third of individuals diagnosed with major depression globally.
According to Zeta Surgical, the FDA clearance authorizes the system’s use as a stereotaxic image-guidance tool for accurate coil positioning to planned brain targets, supporting both therapeutic applications and functional mapping in clinical environments. This allows trained professionals to deploy the system across a range of TMS workflows where precision and consistency are critical to treatment outcomes.
Hieu Le Mau, Chief Operating Officer of Zeta Surgical, stated that the clearance “provides a clear regulatory pathway for broader adoption” of TMS navigation technologies. The system’s capabilities were recently validated in a study conducted in collaboration with the University of Cambridge and Harvard Medical School, demonstrating sub-millimeter translational and sub-degree angular precision across bench, phantom, and cadaver models.
Co-founder and Chief Executive Officer Jose Maria Amich noted that achieving FDA clearance will support clinics in delivering more consistent targeting in TMS sessions, a factor linked to improved therapeutic efficacy. He added that Zeta Surgical aims to make high-accuracy, stereotactic-grade image guidance accessible and practical for everyday neuromodulation procedures.
