CR Mammography Enhancements

Eastman Kodak Co. (Rochester, NY, USA) announced it has submitted the final module of a pre-market approval submission (PMA) to the U.S. Food and Drug Administration (FDA) for approval of its CR system for mammography. The FDA has already accepted and closed review of the earlier submitted modules covering manufacturing information and non-clinical data.

"I look forward to this technology being able to provide the convenience of digital imaging in many healthcare facilities which may not otherwise have access to digital mammography,” said Dr. Sughra Raza, director, Women's Imaging Program, department of radiology, Brigham & Women's Hospital (Boston, MA, USA). Dr. Raza participated in the clinical trials for Kodak's CR for mammography feature.

High-resolution images are critical for helping radiologists identify breast cancer in women who may have no obvious signs of the disease. This novel feature will enable mammography images to be captured digitally with Kodak's CR systems while continuing to use these systems for general radiography exams. This optional feature for Kodak Directview CR 850/950/975 systems will be available when purchasing a new Kodak CR system or as a retrofit to previously installed Kodak systems.

This feature is already being sold in Europe, Greater Asia, Japan, and Latin America, where Kodak has installed hundreds of systems with this feature in facilities ranging from small clinics and breast imaging centers to large hospitals and medical centers.




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