IMRIS Obtains CE Mark for First Ceiling-Mounted Intraoperative CT Solution

barbara.lempert

VISIUS iCT expands state-of-the-art surgical theater imaging into European market

WINNIPEG, MB and MINNEAPOLIS, MN, Aug. 5, 2013 /CNW/ – Inc. (NASDAQ: IMRS) (TSX: IM) (“” or the “Company”) today announced that it has obtained regulatory CE for VISIUS® iCT, the and only ceiling-mounted computed tomography, allowing for sales and marketing in the European Union.

“This is another step in our overall global launch after recently receiving clearance from the FDA,” said Jay D. Miller, IMRIS CEO and President. “European Union spine surgeons now have the opportunity to use this unique in confirming implant placements, fusion and other complex procedures. As procedures become more minimally invasive, the need for better visualization with advanced imaging increases. Both U.S. and European spine surgeons will be especially interested in the outstanding dose management capabilities and state-of-the-art image quality available with VISIUS iCT.”

IMRIS received U.S. Food and Drug Administration (FDA) 510(k) clearance for VISIUS iCT on July 18. The company now has systems sold to three major eastern US neurosciences centers with installations in progress at two of these centers.

VISIUS iCT provides personalized dose management together with diagnostic quality imaging during surgical procedures to assist surgeons in critical decision making and procedure guidance. The 64-slice scanner effortlessly moves into and out of the operating room in about 30 seconds during surgery using ceiling-mounted rails to ease workflow. The scanner can travel into two adjacent operating rooms to allow the hospital to use it for more patients.

Patient transport and need for floor-mounted rails used by other systems are eliminated which opens up valuable OR space and allows unimpeded movement of surgical equipment and maintaining familiar surgical protocols, workflow and infection control procedures. Portable CT…Read more

Pharmalive – The Pulse of the Pharmaceutical Industry

Share This Post

Related Articles

Leave a Reply

© 2018 Global Regulatory Science. All rights reserved. Site Admin · Entries RSS · Comments RSS