Biospace med nets FDA OK on x-ray imager

French digital radiography developer Biospace Med of Paris has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its EOS digital x-ray imager for 2D imaging use.

EOS 2D/3D technology is designed for orthopedic imaging with low-dose radiation and is capable of full-body digital imaging in a single scan.

The company's FDA submission noted that EOS demonstrated a tenfold dose reduction compared to commercially available film systems, without loss of image quality. Its slot-scanning technology is intended to eliminate vertical distortion that can be common with traditional x-ray systems.

EOS' design also allows for multiplanar (frontal and lateral) images obtained simultaneously in an upright, weight-bearing position.

Biospace Med noted that low-dose radiation may be most beneficial to patients with spinal disorders, such as scoliosis, who typically undergo numerous radiographic exams to monitor progression of the disease, as well as to assess treatment effectiveness.

The company is also developing an advanced workstation for the U.S. market. It is designed to generate a 3D skeletal reconstruction from the two simultaneous planar images. The technology also would feature automatic measurement software to calculate various measurements and angles between individual bones and joints.

The 3D workstation currently is commercially available in Europe and Canada.

By AuntMinnie.com staff writers
October 9, 2007

Related Reading

Biospace files 510(k) application, July 9, 2007

French firm Biospace Med prepares for launch of EOS digital x-ray unit, December 25, 2006

Road to RSNA, Biospace Med, October 30, 2006

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