IMRIS, an image-guided therapy solutions provider, has received CE mark for its ceiling-mounted VISIUS intraoperative computed tomography (iCT).
The CE mark will allow the company to sell and market the product in the European Union.
VISIUS iCT helps surgeons in making critical decisions by providing personalised dose management and diagnostic quality imaging.
The iCT features 64-slice scanner equipped with ceiling-mounted rails that allows it to move in and out of the operating room in around 30 seconds during surgery.
In addition, the scanner can travel into two adjacent operating rooms, allowing the hospital to use it for more than one patient.
The ceiling-mounted rail gives the hospital more valuable OR floor space and also allows easy movement of surgical equipment in the operating room.
To maximise image quality and minimise dose, the VISIUS iCT uses 3D volume rendering application that provides surgical planning and dose reduction algorithms for finding patient’s unique characteristics and imaging target.
Based on specific clinical need, the system software can be adjusted to provide dosage visualisation before the scan or detailed dosage reports after each scan.
VISIUS iCT received 510(k) clearance from US Food and Drug Administration (FDA) in July 2013.
IMRIS CEO and president Jay D Miller said this was another step in their overall global launch after recently receiving clearance from the FDA.
"European Union spine surgeons now have the opportunity to use this unique solution in confirming implant placements, fusion and other complex procedures," Miller said. "As procedures become more minimally invasive, the need for better visualiation with advanced imaging increases.
"Both US 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."
The company has already sold VISIUS iCT to three major eastern US neurosciences centres, and is being deployed currently at two of these centres.
Image: IMRIS VISIUS iCT, with image quality and access in the OR, will be available in the EU. Photo: courtesy of IMRIS Inc.