Zeta Surgical Receives FDA Approval for Zeta Cranial Navigation System for Expanded Functionality

Zeta Surgical has received the U.S. FDA special 510(k) clearance of its Zeta Cranial Navigation System for expanded functionality through enhanced software features and compatibility with additional accessories.

Firstly approved by the U.S. FDA in September 2023, the Zeta 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.

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,” said Dr. Roman Stolyarov, Chief Product Officer of Zeta Surgical.

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