ROCHESTER, N.Y. -- Eastman Kodak Company has filed its submission with Health Canada for approval of its computed radiography (CR) system for mammography.

Kodak’s CR mammography platform enables healthcare professionals to capture high-resolution mammography images with traditional x-ray equipment.

The filings are part of Kodak’s plan for obtaining regulatory approval in Canada for its KODAK DIRECTVIEW CR Mammography Feature for CR 850/950/975 Systems.

“Kodak is committed to helping medical facilities around the world benefit from CR for mammography technology,” said Dina Vazzana, General Manager, Mammography Solutions, Kodak’s Health Group. “High-resolution images—like those provided by KODAK CR systems—are critical for helping radiologists identify breast cancer in women who may have no obvious signs of the disease. In addition, the affordability and versatility of CR technology makes this a practical option for medical facilities desiring to expand into digital mammography.”

Health Canada evaluates medical devices for safety, effectiveness and quality before authorizing them for sale in Canada. This Federal department, ultimately, is responsible for helping Canadians maintain and improve their health, while respecting individual choices and circumstances.

Kodak has submitted the final module of a pre-market approval submission (PMA) to the U.S. Food and Drug Administration for approval of its CR system for mammography. Kodak also conducted clinical trials at several sites in the U.S. and Canada.

Kodak’s CR mammography platform can enable healthcare facilities to perform general radiography and mammography exams on the same CR system, and allow them to upgrade or retrofit existing KODAK CR systems for the use in mammography.

Kodak’s Health Group is already selling this product in Europe, Greater Asia, Japan and Latin America, and Kodak has installed hundreds of CR systems with this feature in facilities ranging from small clinics and breast imaging centers to large hospitals and medical centers.

Mammography is currently the most accurate diagnostic modality available for the detection of breast cancer. Breast cancer is the most frequently diagnosed cancer among Canadian women and the second leading cause of cancer death. Mammography screening programs have been established across most Canadian provinces and territories, and the number of mammograms performed yearly has increased substantially.
About Kodak’s Health Group

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