Minneapolis devicemaker IMRIS announced Wednesday that its VISIUS intraoperative computed tomography system has gained regulatory clearance in Australia.
Intended for intraoperative neuro and spinal surgery, the VISIUS iCT is the only available ceiling-mounted intraoperative and diagnostic quality CT that allows doctors to scan patients without moving or repositioning them. “With this unique solution, surgeons can confirm implant placements, fusion and other complex procedure results while still in the OR,” said Jay Miller, CEO and president of IMRIS.
According to the company, the 64-slice scanner can move in and out of the operating room in about 30 seconds using ceiling-mounted rails. IMRIS also offers a two-OR configuration that “can move up to 36.3 feet in each direction for utilization,” company spokesman Kevin Berger told Device Daily Bulletin.
Authorization by the Therapeutic Goods Administration follows FDA 510(k) and CE mark clearances of the VISIUS iCT in July 2013. One system is in place at Duke University and another is “nearing completion and initial use,” Berger said.
IMRIS also makes a ceiling-mounted intraoperative MRI, two of which are installed in Australia. Australia is second to China in spinal implant sales in the Asia Pacific market and the third largest consumer of medical imaging equipment, the company says. The devicemaker opened an office in Singapore last year to focus on region. — Meg Bryant
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