News | October 10, 2007

FDA Clears Biospace Med’s Low Dose X-Ray Imager

October 11, 2007 - Biospace Med announced that it has received 510k clearance from the Food and Drug Administration (FDA) to market EOS, a new digital X-ray imager created for 2D imaging use, reportedly allowing images to be obtained with a low dose of radiation and capable of long-length digital imaging.

EOS 2D/3D technology is part of a total solution to orthopedic imaging, permitting full-body digital imaging with a single scan. According to the company, information submitted to the FDA in support of its marketing application demonstrated up to 10 times reduction in dose when compared with commercially available film systems without compromising image quality.

EOS 2D/3D features reportedly include capturing a full or partial body image, a large reduction in radiation dose and multiplanar (frontal and lateral) images obtained simultaneously in an upright, weight bearing position. EOS is said to differ in several other respects from traditional film, digital X-ray or CT. Its use of slot scanning technology reportedly eliminates vertical distortion that is common with traditional X-ray systems. The simultaneous biplane image acquisition (front and side images acquired at the same time) reportedly eliminates the need for taking a second view and can save time.

For more information: www.biospacemed.com

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