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Zeta Surgical has received FDA 510(k) clearance for its TMS Robotic System as a stereotactic instrument, expanding its portfolio of robotic technologies for transcranial magnetic stimulation (TMS).
The system is designed to provide real-time robotic positioning of TMS coils with submillimeter accuracy, automatically adjusting for patient movement to maintain precise stimulation throughout treatment. It is intended to support the delivery of TMS for conditions including treatment-resistant depression, obsessive-compulsive disorder (OCD), post-traumatic stress disorder (PTSD), and addiction disorders.
The clearance builds on a series of recent regulatory milestones for Zeta, including FDA clearance of its TMS navigation system in 2025 and the first commercial deployment of the platform earlier this year.
Chief Product Officer Benjamin Lee said:
"We designed this to make accurate care easier to deliver, session after session."
The approval strengthens Zeta Surgical's position in image-guided robotic neuromodulation and supports broader adoption of precision TMS in clinical practice.
