Barco's VOXAR COLONSCREEN receives FDA 510(k) clearance for patient screening
ECR,VIENNA, AUSTRIA, 4 March 2005 – Today, Barco announced it has received 510(k) pre-market clearance from the U.S. Food and Drug Administration (FDA) for VOXAR COLONSCREEN, the company’s CT colonography software application. VOXAR COLONSCREEN is now cleared for both the examination of symptomatic patients and the screening of asymptomatic patients for the detection of colonic polyps, tumors and other lesions. The 510(k) clearance for VOXAR COLONSCREEN is an important step forward. The ability to use VOXAR COLONSCREEN as a screening tool for the detection of colon cancer allows medical institutions to offer CT colonography programs to the general public at large.
“Early detection and treatment is crucial in the fight against colorectal cancer. Research suggests that increased compliance with screening can prevent the development of cancer. Barco has developed a time-efficient and workflow-driven CT colonography software application that can now be used in primary screening programs,” explains Matthew Barish, M.D., Chief Medical Officer of the Voxar Product Group.Designed in collaboration with leading experts, VOXAR COLONSCREEN is a physician-focused CT colonography software tool for effective and accurate colon review. VOXAR COLONSCREEN allows physicians to increase their productivity by making the clinical tasks of reading and reporting CT colonography studies easy and efficient. The software’s clinically proven and trusted reading and reporting methodology provides tools for simultaneous 2D and 3D viewing of prone and supine images. Automatic reporting allows physicians to generate on-the-fly reports as they diagnose. These reports can then be exported straight to PACS as a Word document or DICOM report.
“Demand for VOXAR COLONSCREEN has been driven by our customers, who value the software for its efficient and intuitive workflow, optimized to deliver productivity,” says Piet Candeel, Vice President Barco Medical Imaging Systems.
VOXAR COLONSCREEN is a trademark of Barco.
About Barco
Barco, an international company headquartered in Kortrijk, Belgium, provides visualization and display solutions for professional markets. Barco designs and develops solutions for large screen visualization, display solutions for life-critical applications, and systems for visual inspection. Barco is active worldwide and has its own facilities for Sales & Marketing, Customer Support, R&D and Manufacturing in Europe, North America and Asia Pacific. Barco is quoted on Euronext Brussels and is a BEL 20 and a Next 150 company (Euronext: BAR; Reuters: BARBt.BR; Bloomberg: BAR BB).
