Friday, March 1, 2024

Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance -Dlight News

Surgical robotics and mixed reality company Zeta Surgical announced it secured FDA special 510(k) clearance for advanced functionalities and expanded compatibility of its cranial navigation system for neurosurgery.

The mixed-reality navigation system offers surgeons real-time “GPS-like” guidance with millimeter precision.

With a computer vision engine ensuring continuous accuracy despite patient movement, the company says the system removes the necessity for general anesthesia and rigid skull immobilization.

“The Special 510(k) covered several workflow and performance enhancements, such as a streamlined navigation module and ‘uncapped’ navigation speed, which results in faster tracking,” Zeta cofounder and CEO Jose Amich told MobiHealthNews in an email. “It also expanded our compatibility with other accessories.”

The system is powered by RealTrack, Zeta’s proprietary computer vision/AI software, which provides real-time guidance using 3D sensors.

The company plans to launch an initial set of pilots with neurosurgical centers of excellence and broaden the release nationwide.

“Zeta can be used to navigate cases currently performed freehand, which reduces complications and improves efficacy of treatments,” Amich said. “It also allows surgeons to navigate without requiring anesthesia or fixation, which improves the safety and speed of surgical procedures, and importantly, expands the access to navigation to essentially any hospital in the country.”


Mixed reality integrates virtual and augmented elements. MR enhances real-world surgical environments with digital information and visualization in surgery for improved precision and outcomes. Healthcare specialists see the potential to improve efficiency and workflows for surgeons.

Mixed-reality platforms are being developed  and gaining FDA clearance  for use in surgical training programs and for collaboration between care teams in disparate locations. 

In June 2023, Zeta Surgical successfully treated its inaugural patient using the cranial navigation system during a first-in-human trial conducted at Singapore’s National Neuroscience Institute (NNI).

The clinical trial, hosted at NNI-affiliated hospitals, focused on assessing the system’s safety, efficacy and feasibility in pin-less bedside ventriculostomy procedures.

Zeta initially received FDA clearance for its mixed-reality cranial-navigation system in September.

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