Summary: Zeta Surgical’s Zeta Navigation System has received FDA clearance for expanded instruments and enhanced hospital connectivity, supporting a wide range of neurological interventions. The clearance allows deployment with new surgical kits and IT integration for efficient access to patient data.
Key Takeaways:
- Zeta Navigation System provides advanced, real-time navigation for neurological interventions, now compatible with additional instruments and hospital IT systems.
- The clearance supports Zeta Surgical’s goal of improving surgical outcomes and expanding system applications through clinical pilot programs in the U.S.
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.
High-Accuracy Navigation for Neurological Interventions
The Zeta Surgical platform provides 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.
RELATED: FDA Clears Zeta’s Mixed Reality Cranial Navigation System
Expanded Instrumentation and Connectivity
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.”
Pioneers Program and Clinical Pilots
The announcement comes as the company starts the rollout of its Pioneers Program, its first set of commercial pilots aimed at evaluating the use of the Zeta system across a variety of clinical applications. In 2023, the company obtained its first FDA 510(k) clearance and announced the successful completion of its first multicenter clinical trial at two leading sites in Singapore.
“We are excited about the impact our expanded capabilities will have on our pilot programs across the United States,” said Raahil Sha, Co-Founder and Chief Technology Officer of Zeta Surgical. “Our goal has always been to improve surgical outcomes, and this clearance opens up a significantly broader range of procedures that our partner hospitals can access through our minimally invasive system.”
