Zeta Surgical® AI-Powered Navigation System Receives FDA Special 510(k) Clearance for Expanded Indications and Instrument Compatibility

BOSTON, Nov. 6, 2024 /PRNewswire/ -- Zeta Surgical announced today that its Zeta Navigation System has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for use with expanded instruments and enhanced hospital connectivity.

The Zeta Surgical® platform provides rapidly deployable, high-accuracy navigation for the 19.6 million annual neurological interventions currently unsupported by existing navigation systems. Its “GPS-like” guidance system uses mixed reality and advanced motion-aware remote sensing to enable real-time patient tracking, providing unprecedented access to navigation across a wide range of neurological interventions.

This latest FDA clearance enables the Zeta system to be deployed with a variety of new accessories and surgical kits, including instruments from technology leaders such as IZI Medical. The clearance will also allow hospitals to integrate the system’s software into their IT networks, allowing for seamless and fast access to patient data.

“Our vision is to ensure that advanced image-guided technology is no longer confined to specialized operating rooms or surgical suites,” said Hieu Le Mau, Chief Operating Officer at Zeta Surgical. “The addition of new surgical kits substantially broadens the system’s applications, opening up new possibilities in neurosurgical procedures, while the enhanced connectivity with hospital systems allows surgeons to easily transfer and access patient information.”

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