Zeta Surgical's Mixed Reality Navigation System Receives FDA Special 510(k) Clearance for Expanded Functionality
BOSTON, Jan. 11, 2024 /PRNewswire/ -- Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded functionality through enhanced software features and compatibility with additional accessories.
- BOSTON, Jan. 11, 2024 /PRNewswire/ -- Zeta Surgical, a surgical robotics and mixed reality company, announced today that its Zeta Cranial Navigation System has received Special 510(k) clearance from the U.S. Food and Drug Administration (FDA) for expanded functionality through enhanced software features and compatibility with additional accessories.
- The Zeta Cranial Navigation System is a mixed-reality navigation system for neurosurgery, providing surgeons with "GPS-like" guidance with millimetric accuracy in real-time.
- The platform received its first 510(k) clearance from the U.S. FDA in September 2023.
- "We are thrilled to scale Zeta's deployments in the U.S., building on its early successes in clinics," said Jose Amich, Co-Founder and CEO of Zeta Surgical.