Zeta Surgical’s AI-Powered Navigation System Successfully Completes First Clinical Study

Zeta Surgical, a surgical robotics and mixed reality company, announced the completion of its first multicenter clinical trial using the Zeta Cranial Navigation System.

The Zeta Cranial Navigation System is a mixed-reality navigation system for neurosurgery that provides surgeons with “GPS-like” guidance with millimetric accuracy in real time. Zeta’s next-generation computer vision engine enables automatic, motion-aware registration, making navigated neurosurgery feasible for point-of-care delivery at virtually any location.

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The company received its latest 510(k) clearance from the U.S. FDA in January 2024.

The trial was led by NNI Consultant Dr. Min Wei Chen and conducted at Singapore General Hospital and Tan Tock Seng Hospital. It involved fifteen patients requiring elective and emergency ventriculostomy – a routine procedure traditionally performed without navigation, often resulting in revision surgeries and injury. During the trial, all patients were successfully cannulated in a single attempt and with no adverse events.

“We feel very privileged and excited to be part of the forefront of medtech. It has been an enlightening journey watching how the project evolved from the lab to the operating theater. The results of the trial speak for themselves,” said Dr. Chen. “We have learned such valuable lessons together as a team and look forward to the future where I am sure this navigation platform will become one of the key must-haves in the modern neurosurgical unit.”

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“We’re very thankful to our partners at NNI for collaborating with us on this trial,” said Raahil Sha, Co-Founder and Chief Technology Officer of Zeta Surgical. “We look forward to launching commercial pilots across a broader spectrum of procedures, bringing our technology to hospitals across the United States.”

Zeta Surgical is redefining the standard of care for image-guided surgery. Its cutting-edge navigation and robotics platform applies advanced AI to enable high-accuracy image guidance across any point-of-care in minutes, unlocking a new era of less invasive and more effective targeted therapies.

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