French digital radiography (DR) firm Biospace Med of Paris has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its sterEOS 2D/3D workstation for pediatric use in spine applications. sterEOS previously was cleared by the FDA for use in adult spine applications.
The sterEOS workstation is designed for use with the company's EOS digital radiography system, enabling better pre- and postoperative assessment for surgical planning purposes. EOS captures head-to-toe images of children and adults in a standing, weight-bearing position with less radiation dose. The system has already received FDA clearance for use in pediatrics and adults.
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Road to RSNA, Digital X-ray, Biospace Med, Octover 22, 2008
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Biospace adds to executive lineup, November 19, 2007
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