Zeta Surgical, a company specializing in surgical robotics and mixed reality, has obtained FDA special 510(k) clearance for its cranial navigation system for neurosurgery. The system offers real-time guidance with millimeter precision, eliminating the need for general anesthesia and rigid skull immobilization. The Special 510(k) clearance covers workflow and performance enhancements, such as streamlined navigation and faster tracking. Zeta plans to launch pilots with neurosurgical centers and expand nationwide. Mixed reality integrates virtual and augmented elements into real-world surgical environments, improving precision and outcomes. Zeta successfully treated its first patient using the system during a trial in Singapore, focusing on safety and feasibility in bedside procedures.
Source link
Zeta Surgical mixed reality navigation gets FDA special 510(k) clearance
