ZETA SURGICAL Secures FDA 510(k) Clearance for Zeta TMS Robotic System

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ZETA SURGICAL announced that its Zeta TMS Robotic System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). The device is classified as a Class II stereotaxic instrument under 21 CFR 882.4560 and product codes SGE and QFF (K261471).

Transcranial magnetic stimulation, or TMS, is a non-invasive therapy used primarily for treatment-resistant depression, which affects approximately one-third of patients with major depressive disorder. TMS is also being used in other behavioral health conditions, including obsessive-compulsive disorder, PTSD, and addiction disorders. Because TMS is intended to modulate specific brain regions and neural circuits, accurate and repeatable targeting of patient-specific treatment sites is an important component of treatment delivery.

The Zeta TMS Robotic System provides real-time robotic positioning of TMS coils with submillimeter-level accuracy. The system dynamically tracks patient movement throughout treatment and automatically adjusts coil position to help maintain on-target delivery of stimulation. Designed for rapid clinical deployment, the system can be set up in under a minute and used across virtually any point-of-care environment. Accuracy and usability testing of the system was conducted in collaboration with Harvard Medical School and the University of Cambridge.

“The Zeta TMS Robotic System builds on the real-time image guidance already trusted in our TMS deployments,” said Benjamin Lee, Chief Product Officer of ZETA. “It uses that same guidance to dynamically adjust position throughout a session, without asking clinics to change how they already work. We designed this to make accurate care easier to deliver, session after session.”

“This clearance brings operating-room-level navigation and robotic accuracy into a platform that can be rapidly deployed in virtually any clinic,” said William Gormley, MD, MBA, MPH, Co-Founder of ZETA and a neurosurgeon at Mass General Brigham. “By making precise and repeatable TMS delivery easier to integrate into routine clinical care, we believe the system can help expand access to advanced, targeted brain therapies for patients across the country.”