Biospace Medical today has received 510k clearance from the Food and Drug Administration (FDA) to market EOS, a new digital Xray imager in the US for 2D imaging use. EOS 2D/3D technology is part of a total solution to orthopaedic imaging allowing images to be obtained with a low dose of radiation and is capable of long length digital imaging, permitting full-body, uninterrupted digital imaging with a single scan. Information submitted to FDA in support of Biospace Medical’s marketing application demonstrated up to ten times reduction in dose when compared with commercially available film systems - without compromising image quality. Other features that set EOS apart from traditional Xray or Computed Tomography (CT) are:
o Captures a full or partial body image
o Large reduction in radiation dose
o Multi-planar (frontal and lateral) images are obtained simultaneously in an upright, weight bearing position (unavailable in CT) Whole body, standing position imaging is especially valued by orthopaedic surgeons when examining spine and joint alignment, as it provides a more comprehensive clinical view. “EOS represents an advancement in orthopaedic imaging, integrating benefits previously unavailable in the marketplace,” says Marie Meynadier, CEO of Biospace Medical. “Physicians will now be able to obtain accurate images while advancing the cause of lowering radiation dose to patients.” EOS is based upon a patented particle detector technology for which Georges Charpak received the Nobel Prize in Physics. Along with Charpak, Dr Jean Dubousset, a world renowned French paediatric orthopaedic surgeon, also helped design EOS. “The low dose, weight bearing images offer physicians a global view of the entire body and an understanding of the relationships that exist between joints,” Dubousset said. “This insight into balance and posture can provide valuable surgical planning information and may reduce the need for higher dose exams.” EOS 3D is currently commercially available in Europe and Canada only, and is not part of the current FDA clearance.
