Biospace med, developer of the EOS ultra-low dose 2D/3D orthopedic x-ray imager, has obtained its CE mark for marketing in Europe, received approval from the Health Canada Medical Device Bureau and filed a 510k application with the FDA to seek clearance to market EOS in the U.S.
The company also has completed the first two commercial installations which are operational in Bordeaux, France and Pecs, Hungary. Four other Canadian and European hospitals have been involved during the R&D phase of development and performed over 3,000 images of both adult and pediatric cases.
EOS ultra-low dose 2D/3D is based upon a patented particle detector technology for which Georges Charpak received the Nobel Prize in Physics. This detector, which allows images to be obtained with a low dose of radiation, is part of a system that is capable of very long length digital imaging, permitting full-body, uninterrupted digital imaging with a single scan.
EOS differs in several respects from a traditional x-ray or CT. One of the most important features is the ability to capture an accurate, undistorted, full or partial body image with a large reduction in radiation dose. In addition, multi-planar images are obtained simultaneously in an upright, weight-bearing position, which is unavailable with CT. Whole body, standing position imaging is especially valued by orthopedic surgeons when examining spine and joint alignment.