The Zeta system is a device that 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 that is widely used to treat treatment-resistant major depressive disorder (TR-MDD) and for functional brain mapping. The company said the FDA decision supports the use of the system in clinical environments across a range of TMS procedures.