Mixed Reality Neurosurgery Navigation and CAD Detection Systems Gets FDA Clearance

September 26, 2023

The Zeta Cranial Navigation System is a mixed-reality navigation system that provides surgeons with “GPS-like guidance with millimetric accuracy in real time,” the company says.

Zeta’s computer vision engine automatically registers positioning multiple times a second, accounting for patient movement, and eliminates the need for general anesthesia and rigid skull immobilization.

Also obtaining FDA clearance is the CorVista System, a non-invasive medical device system that uses both hardware and software components to evaluate patients for coronary artery disease (CAD) in point-of-care settings.

Using a static machine-learned detection algorithm, the system “rules out significant CAD with a negative predictive value of 99 percent” the company says, while not requiring fasting or radiation.

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