Zeta Surgical wins FDA clearance for TMS navigation system
The Zeta system provides real-time, image-guided positioning for transcranial magnetic stimulation (TMS) procedures.
It is cleared as a Class II stereotaxic instrument, enabling use for accurate coil placement to planned brain targets during TMS treatment.
Zeta’s TMS system combines 3D imaging and motion-aware tracking to maintain alignment even when patients move, helping clinicians improve precision and consistency in TMS therapy.
TMS is a noninvasive neuromodulation technique used to treat treatment-resistant major depressive disorder (TR-MDD) and for functional brain 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, chief operating officer at Zeta Surgical.
The FDA decision supports the use of the system in clinical environments across a range of TMS procedures.
Author summary: Zeta Surgical receives FDA clearance for its TMS navigation system.
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