Zeta wins FDA clearance for TMS robotic stereotactic system

Zeta Surgical announced today that it received FDA 510(k) clearance for its TMS Robotic System as a stereotaxic instrument.

Boston-based Zeta Surgical designed its robotic platform for transcranial magnetic stimulation (TMS). The non-invasive therapy primarily targets treatment-resistant depression, among other behavioral health conditions. Those include obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD) and addiction disorders.

TMS modulates specific brain regions and neural circuits, requiring accurate and repeatable site targeting. Zeta designed its TMS Robotic System to provide real-time robotic positioning of TMS coils with submillimeter-level accuracy. The platform dynamically tracks patient movement and automatically adjusts coil position to maintain on-target stimulation delivery. It offers utility in rapid clinical deployment, with under a minute of setup time in virtually any point-of-care environment.

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