FDA OKs Zeta Surgical’s AI-Powered TMS Navigation System

Zeta Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zeta TMS (transcranial magnetic stimulation) navigation system.

The navigation system offers image-guided, real-time coil positioning for TMS. It combines 3D imaging and motion-aware tracking to maintain target alignment as the patient moves.

TMS is used in neuropsychiatry, especially for treatment-resistant major depressive disorder (TR-MDD), which impacts about a third of patients with major depression globally.

This FDA nod covers using the Zeta TMS navigation system as a stereotaxic image-guidance system to accurately position TMS treatment coils using 3D patient imaging, for use by trained professionals in clinical environments. This supports deployment in a variety of TMS procedures including therapeutic sessions and functional mapping.

“This clearance classifies the system under product codes QFF and SGE—and, to our knowledge, marks the first TMS navigation device cleared under SGE,” said Hieu Le Mau, COO at Zeta Surgical. “It provides a clear regulatory pathway for broader adoption.”

The company recently finished a study with the University of Cambridge and Harvard Medical School showing sub‑millimeter translational and sub‑degree angular precision in bench, phantom, and cadaver testing for navigated TMS using its system.

“We expect this clearance to help clinics deliver more consistent targeting in TMS, which has been shown in research to significantly improve treatment efficacy,” said Jose Maria Amich, co‑founder and CEO of Zeta Surgical. “Our aim is to make stereotactic-grade, high‑accuracy image guidance practical in everyday neuromodulation workflows.”

In December, the Zeta navigation system earned FDA clearance for use with expanded instruments and enhanced hospital connectivity.