Boston-based Zeta develops computer-assisted, real-time image guidance technology for the spatial positioning and orientation of neurosurgical instruments. Its system utilizes computer vision and AI to align preoperative CT or MRI scans with patient anatomy. This helps provide millimeter-level navigation at virtually any point of care.
The company’s cleared instruments provide navigated guidance for procedures such as the placement of catheters and shunts, brain biopsies and trigeminal rhizotomies. These capabilities target common neurosurgical interventions with limited neuronavigation support. According to the company, its offering provides critical care for traumatic brain injuries, brain tumors and trigeminal neuralgia.
Zeta now boasts a range of FDA clearances for its technologies, including for transcranial magnetic stimulation (TMS), expanded software functionality, mixed reality technology and new AI-powered navigation capabilities.
The company said a recent 15-patient first-in-human trial demonstrated optimal outcomes across all cases in ventriculostomies. Its system achieved single-pass, ideal placements with a median setup time under three minutes. Next, it plans to launch a large-scale commercial pilot program with the Big 10 Neurosurgical Consortium this year.
Commentary from Zeta Surgical officials
Hieu Le Mau, COO at Zeta Surgical, said:
“The FDA clearance of the Zeta Stylet and Zeta Bolt marks a significant milestone for our surgical portfolio. These instruments integrate directly with Zeta, giving surgeons greater precision and confidence across a range of neurosurgical procedures, from external ventricular drain placement and brain biopsy to shunt procedures and rhizotomy.”
William Gormley, co-founder of Zeta Surgical and director of neurosurgical innovation at Harvard Medical School’s Brigham and Women’s Hospital, said:
“Our mission has always been to democratize high quality neurosurgical care for all patients, independent of treatment site. Today the FDA has taken a step forward in this mission with their approval of the latest set of Zeta’s instruments intended to perform complex neurosurgical procedures, not only in sophisticated operating rooms at tertiary care centers, but also at the patient’s bedside, and in any community hospital and ambulatory surgical center in the world.”
