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U.S. FDA Approves Improved Performance of Riverain Medical's OnGuard Chest X-ray Computer-Aided Detection Technology

Mon, 06/21/2010 - 6:34am
Bio-Medicine.Org

DAYTON, Ohio, June 21 /PRNewswire/ -- Riverain Medical® announced today that the U.S. Food and Drug Administration (FDA) has granted approval for the newest version of the OnGuard™ Chest X-ray Computer-Aided Detection (CAD) technology. OnGuard identifies solitary pulmonary nodules that may represent early-stage lung cancer on an existing chest X-ray (1). This improved performance demonstrates a 73% reduction in false positive marks and 50% higher relative sensitivity compared to the original product (2).

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More than 200,000 Americans will be diagnosed with lung cancer this year. Only a small percentage of these patients will be diagnosed with lung cancer in the earliest stages when it is most treatable. When lung cancer is detected early, five-year survival rates triple (3). Multiple studies demonstrate that OnGuard can detect 37-50% of lung cancers that were missed in the initial interpretation (4),(5).

"Our published studies demonstrate that OnGuard can detect up to 50% of the lung cancers that were missed in the initial interpretation," says Dr. Charles White, Professor and Vice Chairman of Radiology a

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