FDA OKs Zeta’s Robotic, Stereotactic TMS System

Zeta Surgical has received U.S. Food and Drug Administration (FDA) 510(k) clearance for its Zeta TMS robotic system as a Class II stereotactic instrument.

Transcranial magnetic stimulation (TMS) is a non-invasive therapy mainly used for treatment-resistant depression that’s also being used to treat obsessive-compulsive disorder, PTSD, and addiction disorders. TMS modulates specific brain regions and neural circuits to provide treatment.

The Zeta TMS robotic system provides real-time robotic positioning of TMS coils with submillimeter accuracy, automatically adjusting for patient movement to maintain precise stimulation delivery. Designed for rapid deployment, it can be set up in under a minute and used in virtually any point-of-care setting. The system was validated through accuracy and usability testing conducted with Harvard Medical School and the University of Cambridge.

In May, the company earned FDA clearance for its Zeta navigation system, as well as its Zeta Stylet and Zeta Bolt navigated instruments.

Comments from Zeta Surgical execs

Benjamin Lee, chief product officer: “The Zeta TMS Robotic System builds on the real-time image guidance already trusted in our TMS deployments. 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.”

William Gormley, MD, MBA, MPH, co-founder and neurosurgeon at Mass General Brigham: “This clearance brings operating-room-level navigation and robotic accuracy into a platform that can be rapidly deployed in virtually any clinic. 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.”