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Zeta Surgical has announced that the FDA has granted 510(k) clearance for its Zeta Navigation System, expanding its capabilities.

The new clearance allows the system to be used with additional instruments and offers enhanced connectivity to hospital networks. This approval comes less than a year after the Boston-based company received FDA clearance for expanded software features. Zeta Surgical’s mixed reality (MR) system initially received FDA approval in September.

Zeta Surgical’s platform delivers high-precision, quickly deployable navigation for neurological procedures that current navigation systems cannot support. It utilizes a GPS-like guidance system with mixed reality and advanced motion-aware remote sensing, enabling real-time tracking of patients and facilitating navigation across a wide range of neurological interventions.

The latest clearance permits the system to be used with a variety of new surgical tools and accessories, including instruments from industry leaders like IZI Medical. It also allows hospitals to integrate the system’s software with their IT networks, providing seamless 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, 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.”