FDA greenlights Vuze Medical's software imaging system used during spinal operations
The U.S. Food and Drug Administration has given Vuze Medical the greenlight for its image processing software that helps guide surgeons during spinal procedures, the company announced recently.
The 510(k) clearance pertains to the Vuze System, a software-only, cross-sectional image guidance and verification tool used during surgery. The system uses simple anteroposterior X-rays, in addition to the cross-sectional images of preoperative CT scans, to give surgeons a real-time graphical overlay.
“Our early experience has demonstrated very high surgical accuracy and the Vuze System is proving to be extremely useful,” Ory Keyman, MD, with the Rambam Medical Center in Israel, said in a statement. “Furthermore, we believe that the Vuze System will enable us to perform a broader range of surgeries in a minimally-invasive manner.”
Keyman was among the first to successfully use the tool while performing minimally invasive spinal surgeries.
The system does not require sensors, cameras or additional calibrations of the surgical site. In addition, the announcement states that the system does not need add-ons or modifications in order to be used in conjunction with most standard surgical tools or implants.
Vuze Medical is a privately-owned medical technology company that specializes in offering surgeons guidance during common spinal procedures.
In addition to her background in journalism, Hannah also has patient-facing experience in clinical settings, having spent more than 12 years working as a registered rad tech. She began covering the medical imaging industry for Innovate Healthcare in 2021.