FDA Clears Biospace med's Revolutionary Low Dose X...( Technology Provides a 'Total ...)

Technology Provides a 'Total Solution' to Orthopedic Imaging

PARIS and ATLANTA, Oct. 9 /PRNewswire/ -- Biospace med today announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market EOS, a new digital Xray imager in the United States for 2D imaging use.

EOS 2D|3D technology is part of a total solution to orthopedic 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 med's marketing application demonstrated up to 10 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:

-- Captures a full or partial body image

-- Large reduction in radiation dose

-- 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 orthopedic surgeons when examining spine and joint alignment, as it provides a more comprehensive clinical view.

"EOS represents an advancement in orthopedic imaging, integrating benefits previously unavailable in the marketplace," says Marie Meynadier, CEO of Biospace med. "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 pediatric orthopedic 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," D
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