The US Food and Drug Administration (FDA) has granted special 510(k) clearance to the Zeta Surgical Navigation System, expanding its indications and compatibility with additional instruments.
The AI-powered system is designed to provide high-precision navigation for the millions of neurological procedures that currently lack advanced navigational support.
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Utilising mixed reality and motion-aware remote sensing, the platform offers “GPS-like” guidance for real-time patient tracking during surgery.
With this latest FDA clearance, the Zeta system can now be used with a wider array of surgical accessories and kits, including those from IZI Medical.
The system’s software can also be integrated into hospital IT networks, streamlining access to crucial patient data.
Zeta Surgical chief operating officer Hieu Le Mau said: “Our vision is to ensure that advanced image-guided technology is no longer confined to specialised operating rooms or surgical suites.
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By GlobalData“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.”
The company has initiated its Pioneers Programme in the US, a limited market release that precedes a more comprehensive launch planned for 2025.
This programme is set to evaluate the Zeta system in various clinical settings.
In 2023, Zeta Surgical achieved its first FDA 510(k) clearance and reported the successful conclusion of its initial multicentre study at two prominent Singaporean institutions.
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 programmes across the US.
“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.”
In June 2024, Zeta Surgical announced the completion of its first multicentre clinical trial examining its Zeta cranial navigation system, an AI-enabled cranial guidance device designed to be used in surgery.
