Zeta Surgical announced the FDA granted 510(k) clearance for its Zeta Navigation System for expanded capabilities. The clearance applies to use with expanded instruments and enhanced hospital connectivity. This clearance comes less than a year after the Boston-based company got an FDA nod for expanded software functionality. Zeta Surgical’s mixed reality (MR) system initially received FDA clearance in September.
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Zeta Surgical’s platform provides rapidly deployable, high-accuracy navigation for neurological interventions currently unsupported by existing navigation systems. It features a GPS-like guidance system using mixed reality and advanced motion-aware remote sensing. The platform enables real-time patient tracking, providing access to navigation across a wide range of neurological interventions.
The latest clearance allows for deployment of the system with a variety of new accessories and surgical kits. That includes instruments from technology leaders like IZI Medical, according to a news release. It also enables hospitals to integrate the system’s software into their IT networks for access to patient data.
“Our vision is to ensure that advanced image-guided technology is no longer confined to specialised operating rooms or surgical suites,” said Hieu Le Mau, COO of 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.”
