Sam Brusco, Associate Editor01.11.24
Zeta Surgical, a surgical robotics and mixed reality company, has gained a special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zeta cranial navigation system. The FDA nod expands its functionality via enhanced software features and compatibility with special accessories.
The Zeta cranial navigation system is a mixed-reality neurosurgical navigation system that offers “GPS-like” guidance with millimetric accuracy in real-time, according to the company. Its computer engine maintains accuracy by automatically registering multiple times a second to account for patient movement. It also allows for awake and non-immobilized use in operative and extra-operative settings.
The Zeta platform gained its first FDA clearance in September 2023.
Dr. Roman Stolyarov, chief product officer of Zeta Surgical, commented, "This new FDA clearance enables key enhancements in usability and performance, bringing us closer to achieving our mission of dramatically reducing the barriers to surgical navigation and unlocking its benefits for a wider array of patients and procedures."
"We are thrilled to scale Zeta's deployments in the U.S., building on its early successes in clinics," added Jose Amich, co-founder and CEO of Zeta Surgical. "We look forward to seeing Zeta's impact on patient outcomes and in the field of neuroscience."
The Zeta cranial navigation system is a mixed-reality neurosurgical navigation system that offers “GPS-like” guidance with millimetric accuracy in real-time, according to the company. Its computer engine maintains accuracy by automatically registering multiple times a second to account for patient movement. It also allows for awake and non-immobilized use in operative and extra-operative settings.
The Zeta platform gained its first FDA clearance in September 2023.
Dr. Roman Stolyarov, chief product officer of Zeta Surgical, commented, "This new FDA clearance enables key enhancements in usability and performance, bringing us closer to achieving our mission of dramatically reducing the barriers to surgical navigation and unlocking its benefits for a wider array of patients and procedures."
"We are thrilled to scale Zeta's deployments in the U.S., building on its early successes in clinics," added Jose Amich, co-founder and CEO of Zeta Surgical. "We look forward to seeing Zeta's impact on patient outcomes and in the field of neuroscience."