Imris has obtained Therapeutic Goods Administration (TGA) regulatory listing for its ceiling-mounted Visius intraoperative computed tomography (iCT).
With this clearance, the Imris Visius iCT is claimed to be the only ceiling-mounted intraoperative CT with low dose management available for sale in Australia.
Visius iCT serves as surgical theatre that not only offers personalised dose management but also diagnostic quality imaging when a surgical procedure is performed, which will help surgeons in taking critical decisions.
Imris president and CEO Jay D Miller said this is another step in company’s overall global launch following US and European approvals.
"Visius iCT offers the highest image quality of competing intraoperative systems along with market leading dose management capabilities," Miller said.
"As procedures become less invasive, the need for better visualisation with advanced imaging during procedures and low radiation exposure increases. With this unique solution, surgeons can confirm implant placements, fusion and other complex procedure results while still in the OR."
Equipped with a 64-slice scanner, Visius iCT, using ceiling-mounted rails, can easily move into and out of the operating room in about 30 seconds during surgery using ceiling-mounted rails to ease workflow.
This system allows multiple room configurations in order to meet clinical requirements, and also boost utilisation without affecting the exam speed or quality of images.
In addition, it eliminates transportating patients and requirements for floor-mounted rails as found in other systems, opening up OR space and enabling unrestricted movement of surgical equipment and infection control in a simplified way.
The company claims that its system currently provides the longest scanner travel range in the market.
Visius iCT also comes with a group of software applications such as 3D volume rendering that help in surgical planning and dose reduction based on every patient’s individual characteristics.
Its software enables physicians to visualise dosage even before the scan and adjust settings depending on the particular clinical requirement.
The company currently has two customers with Visius intraoperative MRI (iMRI) installations at Royal Children’s Hospital in Melbourne and Canberra Hospital in Canberra in Australia.
In order to increase focus on the growing Asia Pacific market, the company established an an office in Singapore last year.
Imris had received the US Food and Drug Administration (FDA) 510(k) and CE mark clearance for Visius iCT in July 2013.
Image: Imris receives Australian regulatory clearance for intraoperative CT solution. Photo: courtesy of CNW Group/Imris Inc.