ZETA SURGICAL

ZETA Surgical Inc. is a privately held medical technology company based in Boston, Massachusetts, that develops computer-assisted surgery systems for neurosurgery and interventional neuroradiology. Its core product, the ZETA (Zeta) Navigation System, is a frameless, real-time image-guided cranial navigation platform that uses computer vision and artificial intelligence to register patient anatomy and track patient movement without rigid head fixation, cranial pins or general anesthesia. The AI engine ingests standard CT and MRI scans to construct a high-resolution 3D head model, while the company's RealTrack markerless registration technology aligns live camera capture with that model and continuously adjusts for patient motion; the company states the system tracks patient movement 20 times per second, deploys in under five minutes from a single cart, and presents instrument trajectory and accuracy metrics on a clinical dashboard.

The platform is indicated for spatial positioning and orientation of neurosurgical instruments in cranial surgery where a rigid anatomical reference can be identified, for use in operating rooms and less acute settings such as interventional procedure suites. Applications described by the company include external ventricular drain placement, brain biopsy, tumor resection (including cavernoma resection) and transcranial magnetic stimulation, with separate compatible instruments and accessories such as the Zeta Stylet and Zeta Bolt. A separate line, the Zeta TMS Navigation System and Zeta TMS Robotic System, brings navigated targeting to transcranial magnetic stimulation therapy. The company has also described development of ZetaFUS, a non-invasive focused ultrasound system for intracranial drug delivery navigated by ZETA, and is a member of the Focused Ultrasound Foundation.

Founding story

Jose Amich and Raahil Sha started the company in 2018 as Harvard University undergraduates, partnering with William Gormley, a Harvard Medical School professor and Brigham and Women's Hospital neurosurgeon. Sha graduated from Harvard in 2018 with a B.A. in computer science; Amich and Gormley are alumni of the MIT Sloan School of Management MBA program.

Business model

ZETA Surgical sells FDA-cleared navigation hardware and software systems, together with compatible navigated instruments and accessories, to hospitals and clinics. Its Zeta Navigation System and Zeta TMS Navigation System are described as commercially available in the United States.

Revenue derives from commercial sales of the FDA-cleared Zeta Navigation System and Zeta TMS Navigation System and associated navigated instruments and accessories in the United States.

Traction

The company reports FDA 510(k) clearances beginning in September 2023 with subsequent expansions, completion of a first multi-center trial at Singapore General Hospital and Tan Tock Seng Hospital in 2024, and in 2026 first commercial deployment and first patient treatment with the Zeta TMS Navigation System at HOPE Therapeutics clinics in West Palm Beach and Sarasota, Florida. A clinical study of bedside external ventricular drain placement reported 100% single-pass catheter placement, 100% ideal placement, and no revision surgeries or adverse events, compared with freehand results of 81%, 32%, 19% and 28% respectively. Y Combinator lists a team size of 12.

Latest developments

In May 2026 the Zeta Navigation System with the Zeta Stylet and Zeta Bolt instruments received FDA 510(k) clearance covering brain tumor biopsy, hydrocephalus and trigeminal neuralgia applications, and the first commercial deployment of the Zeta TMS Navigation System was announced at HOPE Therapeutics in West Palm Beach, Florida. In June 2026 the first patient was treated with the system at a HOPE Therapeutics clinic in Sarasota. In July 2026 the Zeta TMS Robotic System received FDA 510(k) clearance as a Class II stereotaxic instrument (K261471).