March 13, 2008 iCAD prepares CR mammography CAD for market Labeling negotiations with FDA near end, chief exec predicts 2Q launch ------------------------------------------------------------------------------- The director of the FDA's Office of Device Evaluation has informed iCAD that the agency will approve its SecondLook Digital computer-aided detection software for use on Fujifilm's computed radiography mammography system (CRm), according to Ken Ferry, president and CEO of the company. iCAD has spent 20 months seeking FDA approval for the software. The ODE director personally conveyed the approval decision to the company in an e-mail, Ferry said. In response iCAD has provided "certain deliverables," which the FDA official found satisfactory, he said. "Basically we are working on labeling," he said.
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