Zeta Surgical announced today that the FDA granted it a special 510(k) clearance for expanded software functionality.
The Zeta cranial navigation system’s special clearance applies to enhanced software features and compatibility with additional accessories. Zeta Surgical’s mixed reality (MR) system initially received FDA clearance in September.
The Zeta cranial navigation system provides surgeons with GPS-like guidance and millimetric accuracy in real time. Boston-based Zeta Surgical designed it with a computer vision engine to ensure maintained accuracy. It automatically registers multiple times per second, accounting for patient movement.
Users can deploy Zeta both inside and outside the operating room. This feature eliminates the need for general anesthesia and rigid skull immobilization.
Dr. Roman Stolyarov, Chief Product Officer of Zeta Surgical, said the latest FDA clearance enables “key enhancements in usability and performance.” Stolyarov added that it brings the company closer to achieving its 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,” said 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.”