Zeta Surgical Reports Mixed Reality Navigation System Receives FDA Special 510(k) Clearance for Expanded Functionality

Zeta Surgical

Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded functionality through enhanced software features and compatibility with additional accessories.

Zeta Cranial Navigation System

The Zeta Surgical Cranial Navigation System is a mixed-reality navigation system for neurosurgery, providing surgeons with “GPS-like” guidance with millimetric accuracy in real-time. Zeta’s computer vision engine ensures maintained accuracy by automatically registering multiple times a second, accounting for patient movement, and allowing for awake and non-immobilized use in both operative and extra-operative settings. The platform received its first 510(k) clearance from the U.S. FDA in September 2023.

Dr. Roman Stolyarov, Chief Product Officer of Zeta Surgical, commented on the clearance:

“This new FDA clearance enables key enhancements in usability and performance, bringing us closer to achieving our mission of dramatically reducing the barriers to surgical navigation and unlocking its benefits for a wider array of patients and procedures.”

“We are thrilled to scale Zeta’s deployments in the U.S., building on its early successes in clinics,” said Jose Amich, Co-Founder and CEO of Zeta Surgical. “We look forward to seeing Zeta’s impact on patient outcomes and in the field of neuroscience.”

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Gabriel Sanchez, Ph.D., CEO and co-founder of Enspectra Health. "This significant achievement is the result of the excellent work by the Enspectra Health team and our clinical advisors. Our submission was cleared by the FDA ahead of plan, underscoring our ability to successfully drive an innovative technology from concept to clearance."

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