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IMRIS Receives FDA 510K Clearance For First Ceiling-mounted Intraoperative CT Solution

VISIUS iCT establishes level of intraoperative imaging previously unavailable to surgeons

WINNIPEG, July 22, 2013 /PRNewswire/ - IMRIS Inc. (NASDAQ: IMRS; TSX: IM) ("IMRIS" or the "Company") today announced US Food and Drug Administration (FDA) 510K clearance to market VISIUS ® iCT, the first and only ceiling-mounted intraoperative computed tomography (iCT) on the market.

"This revolutionary IMRIS solution will be an essential part of the hybrid operating room of the future, especially for the spinal and neurosurgical market," said David Graves, IMRIS CEO. "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."

VISIUS iCT is a state-of-the-art surgical theater that provides personalized dose management together with diagnostic quality imaging during the surgical procedure to assist surgeons in critical decision making. The 64-slice scanner effortlessly moves into and out of the operating room during surgery using ceiling-mounted rails to ease workflow. This enables multiple room configurations to meet both clinical requirements and increase utilization without compromising image quality or exam speed.

Patient transport and the need for floor-mounted rails used in other systems is eliminated which opens up valuable OR space and allows unimpeded movement of surgical equipment and simplified infection control. The system also offers the longest scanner travel range on the market today.

In addition, VISIUS iCT features a suite of software applications such as 3D volume rendering to aid in surgical planning and dose reduction which considers each patient's unique characteristics and needs to maximize image quality and minimize dose. "State-of-the-art dose management is one of the keys to driving the adoption of iCT to guide surgical procedures," Graves said.

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