Zeta Surgical

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 perfor…

Zeta Surgical announced today that the FDA cleared its mixed reality surgical navigation system for neurosurgery.

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.

According to a news release, users can deploy Zeta both inside and outside the operating room. This feature eliminates the need for general anesthesia and rigid skull immobilization.

In March 2022, Zeta Surgical announced that it raised $5.2 million to support its navigation and surgical robotic platforms. It listed one of its next steps following the funding as obtaining this FDA clearance.

“The FDA’s market clearance of the Zeta Navigation system ushers in the next generation of innovation to neurosurgery,” Dr. William …

Surgical robotics and mixed reality company Zeta Surgical announced today that it closed a $5.2 million financing round.

Boston-based Zeta Surgical’s financing round was led by Innospark Ventures, with participation from TSVC, Y Combinator, Trevor Fetter and more.

The company said in a news release that it will use the funds to finalize the development of its Zeta neurosurgical navigation platform as well as its ZetaFUS non-invasive focused ultrasound system.

Among the next steps for the company with the additional funds is the completion of their initial clinical studies, obtaining FDA clearance and expanding Zeta Surgical’s technical and clinical teams.

“To date, the use of surgical guidance has been limited to long, operating room-based interventions, due to its invasiveness and complex deployment,” Zeta Surgical Co-Founder and CEO Jose Amich said in the release. “Our goal is to provide physicians with a robust, fa…