US-based medical technology company Zeta Surgical has secured the US Food and Drug Administration (FDA) 510(k) approval for its AI-powered Zeta navigation system.
The mixed reality surgical navigation system was already approved in the US for neurosurgery use and was expanded to include enhanced software and compatibility.
The current FDA approval expands the AI-powered navigation system’s indication to include use with expanded instruments and enhanced hospital connectivity.
It enables the deployment of the Zeta system with different new accessories and surgical kits, including instruments from top medical technology providers, such as IZI Medical.
Also, the third FDA approval allows hospitals to integrate Zeta navigation system’s software into their IT networks, to facilitate easy and fast access to patient data, said Zeta.
Zeta Surgical COO Hieu Le Mau said: “Our vision is to ensure that advanced image-guided technology is no longer confined to specialized operating rooms or surgical suites.
“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.”
Zeta Surgical said its platform provides deployable, high-accuracy navigation for neurological interventions that are currently unsupported by existing navigation systems.
Its navigation system leverages mixed reality and advanced motion-aware remote sensing to enable real-time patient tracking, to provide surgeons with GPS-like guidance.
The system provides enhanced access to navigation across a wide range of neurological interventions.
Zeta Surgical plans to deploy its Zeta surgical navigation system in the US through a limited market release, under its Pioneers Programme, with a broader launch planned in 2025.
Pioneers Programme is a recently launched initiative that aims to evaluate the Zeta system across diverse clinical applications in commercial pilots.
Zeta Surgical co-founder and chief technology officer Raahil Sha said: “We are excited about the impact our expanded capabilities will have on our pilot programs across the United States.
“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.”
