#United States #FDA Approval #Boston #Zeta Surgical #TMS Navigation

Zeta Surgical's TMS Navigation System Receives FDA 510(k) Clearance

On October 13, 2025, Zeta Surgical announced a significant milestone with the FDA granting 510(k) clearance for its Zeta TMS Navigation System. This achievement allows the device, classified as a Class II stereotaxic instrument, to enhance the accuracy of transcranial magnetic stimulation (TMS) procedures.

The Zeta TMS Navigation System integrates cutting-edge 3D imaging with real-time coil positioning, effectively enabling practitioners to maintain target alignment even when patients move. This technological advancement is especially relevant for conditions such as treatment-resistant major depressive disorder (TR-MDD), which affects about one-third of individuals diagnosed with major depression globally.

The FDA's notice acknowledges the system’s capability as a stereotaxic image-guidance tool, allowing trained professionals to accurately position TMS coils to predetermined brain targets. Zeta Surgical aims to utilize this system in various TMS applications, including therapeutic sessions and functional mapping, thereby expanding the scope of TMS in clinical settings.

Hieu Le Mau, the Chief Operating Officer at Zeta Surgical, stated, "This clearance classifies the system under product codes QFF and SGE, marking the first TMS navigation device cleared under SGE. It provides a clear regulatory pathway for broader adoption."

Recent studies conducted in collaboration with Harvard Medical School and the University of Cambridge showcased the system's sub-millimeter translational precision and sub-degree angular accuracy, both critical for enhancing the efficacy of TMS treatments. Jose Maria Amich, Co-Founder and CEO of Zeta Surgical, expressed optimism regarding the clearance, stating, "We expect this clearance to help clinics deliver more consistent targeting in TMS, which has been shown in research to significantly improve treatment efficacy."

The Zeta TMS Navigation System is poised to redefine workflows in neuromodulation by making high-accuracy image guidance practical across various clinical environments. As neuromodulation techniques continue to gain traction, Zeta Surgical's innovations position it at the forefront of integrating AI technologies in healthcare.

In conclusion, the receipt of FDA clearance represents not just a regulatory achievement for Zeta Surgical, but a significant stride towards delivering more effective treatment solutions for patients battling severe mental health disorders. Zeta Surgical remains committed to refining the standard of care in the realm of image-guided surgeries and therapies, signifying a promising future for precision medicine.

For further information and updates on Zeta Surgical’s developments and product offerings, visit www.zetasurgical.com.