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IMRIS receives regulatory clearance for intraoperative CT solution in Australia

IMRIS, an image-guided therapy solutions provider, has obtained Therapeutic Goods Administration (TGA) regulatory clearance for its ceiling-mounted VISIUS intraoperative computed tomography (iCT).

IMRIS, an image-guided therapy solutions provider, has obtained Therapeutic Goods Administration (TGA) regulatory clearance for its ceiling-mounted VISIUS intraoperative computed tomography (iCT).

It is claimed to be the only ceiling-mounted intraoperative computed tomography, allowing for sales and marketing in Australia.

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.

Imris president and CEO Jay D Miller said this is another step in the 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 added.

"As procedures become less invasive, the need for better visualization 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."

The company currently has two Australian customers with VISIUS intraoperative MRI (iMRI) installations at Royal Children’s Hospital in Melbourne and Canberra Hospital in Canberra.
In 2013, IMRIS established an office in Singapore to increase focus on the growing Asia Pacific market.

VISIUS iCT received 510(k) clearance from US Food and Drug Administration (FDA) and CE Mark clearance in July 2013. The company now has several systems sold to major US neurosciences centers.