Zeta Surgical’s transcranial magnetic stimulation (TMS) robotic navigation system, designed to make delivering the treatment modality in treatment-resistant depression (TRD) more reproducible, has obtained US Food and Drug Administration (FDA) clearance.
TRD is a severe form of major depressive disorder (MDD) that fails to adequately improve after patients have tried at least two different antidepressant medications at standard doses and duration.
During TMS treatment for TRD, magnetic fields are delivered via electromagnetic coils placed against the scalp to stimulate nerve cells in the brain to improve depressive symptoms.
Classified by the FDA as a Class II stereotaxic instrument, Zeta’s system uses AI and computer vision to track patient movement during TMS treatment, automatically adjusting coil position as patients move in order to maintain on-target delivery of the treatment modality.
Since 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, Zeta stated.
Ahead of FDA clearance, the accuracy and usability of Zeta’s system were evaluated in a collaboration between the Boston-based company’s partners, Harvard Medical School and the University of Cambridge, though no exact clinical data was disclosed.
Zeta’s co-founder, Dr William Gormley, commented: “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.”
Preceding the 10 July clearance of Zeta’s TMS robot, in May 2026, the navigation technology underlying the system, in conjunction with Zeta’s Bolt and Stylet navigation instruments, gained FDA clearance for providing guidance in neurosurgical procedures including external ventricular drain placement and catheter placement in cerebral shunt.
Neuromodulation-based medical devices such as TMS have become an established modality in the depression treatment landscape. Neuronetics’ NeuroStar TMS therapy system became the first device to receive FDA clearance for MDD treatment in 2008. The treatment modality is also being used in behavioural health conditions, including obsessive-compulsive disorder (OCD) and is in clinical trials for post-traumatic stress disorder (PTSD).
Meanwhile, other neuromodulation therapies are being applied across a broad range of neurological conditions. For example, deep brain stimulation (DBS) is used to treat disorders such as Parkinson's disease, while non-invasive neuromodulation approaches like afferent partnered stimulation (TAPS) therapy are also being used for neurological symptoms such as tremors.
According to GlobalData analysis, the global neuromodulation device market is projected to reach a valuation of over $13bn in 2035, up from around $6.8bn in 2025.
