FDA Clears Imris Ceiling-Mounted CT Scanner

Imris Inc., an imaging technology company based in Winnipeg, Manitoba, Canada, has received U.S. Food and Drug Administration 510(k) clearance to market its Visius iCT, a ceiling-mounted intraoperative computed tomography (CT) scanner.

“This…Imris solution will be an essential part of the hybrid operating room of the future, especially for the spinal and neurosurgical market,” predicted David Graves, Imris CEO. “Visius iCT provides surgeons with on-demand CT imaging to enhance decision making, and both guides and confirms implant placement. The spine surgery market represents a new opportunity for Imris and Visius iCT establishes a level of intraoperative imaging previously unavailable to surgeons and patients.”

Visius iCT is a surgical theater designed to provide personalized dose management together with diagnostic quality imaging during the surgical procedure. It is a 64-slice scanner, and is portable for moveability inside and outside the operating room on ceiling-mounted rails. According to the company, this enables multiple room configurations to meet both clinical requirements and increase utilization. Ceiling-mounted rails open up floor space in the operating room.

Visius iCT also features a suite of software applications such as 3-D volume rendering to aid in surgical planning and dose reduction, which considers each patient’s unique characteristics and needs to maximize image quality and minimize dose.

“State-of-the-art dose management is one of the keys to driving the adoption of iCT to guide surgical procedures,” Graves said.

The system software reportedly allows healthcare practitioners to visualize dosage prior to scan and adjust settings based on the specific clinical need with detailed dosage reports produced after each scan.