IMRIS has secured US Food and Drug Administration (FDA) 510K approval to market its VISIUS iCT, a ceiling-mounted intraoperative computed tomography (iCT).
VISIUS iCT serves a surgical theater, providing personalized dose management along with diagnostic quality imaging during a surgical procedure, which will aid surgeons in making critical decisions.
It is equipped with a 64-slice scanner, which enables the device to moves into and out of the operating room during surgery using ceiling-mounted rails.
The device also allows multiple room configurations, which can improve utilization while not compromising on image quality or speed of the examination.
Both patient transport and the need for floor-mounted rails as in other systems can be eliminated. It also enables unconstrained movement of surgical equipment and simplified infection control.
According to the company, this system offers the longest scanner travel range currently available in the market.
IMRIS CEO David Graves said the IMRIS solution will be an essential part of the hybrid operating room of the future, especially for the spinal and neurosurgical market.
"VISIUS iCT provides surgeons with on-demand CT imaging to enhance decision making, and both guide and confirm implant placement. The spine surgery market represents a new opportunity for IMRIS and VISIUS iCT establishes a level of intraoperative imaging previously unavailable to surgeons and patients," Graves added.
