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Zeta Surgical's Mixed Reality Navigation System gains FDA Special 510(k) Clearance for expanded functionality

Thursday, January 11, 2024

Zeta Surgical, a company specializing in surgical robotics and mixed reality, reported today that its Zeta Cranial Navigation System has obtained Special 510(k) clearance from the U.S. Food and Drug Administration (FDA). This clearance is attributed to the system's extended functionality, which includes enhanced software features and compatibility with additional accessories.

The Zeta Cranial Navigation System is designed for neurosurgery, providing surgeons with real-time, millimetrically accurate guidance akin to a "GPS-like" system. The system's computer vision engine ensures ongoing accuracy by registering multiple times per second, accommodating patient movements.

It is suitable for both operative and extra-operative settings, including awake and non-immobilized scenarios. The recent FDA clearance paves the way for notable improvements in usability and overall performance.





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