Kodak Files With Health Canada for Approval of Kodak’s CR System for Mammography
ROCHESTER, N.Y., Dec. 19 -- Eastman Kodak Company announced it has filed its submission with Health Canada for approval of its computed radiography (CR) system for mammography.
(PressZoom) - 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 Kodak’s Health Group, with 2005 revenues of $2.65 billion, is a world leader in supplying the medical and dental professions with advanced healthcare products, services and information technology solutions. Its broad portfolio includes picture archiving and communications systems (PACS), radiology information systems (RIS), healthcare information systems, computed radiography (CR) and digital radiography (DR) systems, laser imagers, mammography and oncology systems, x-ray film systems, dental imaging products, and a range of consulting—as well as repair and maintenance—services.
Kodak is the world’s foremost imaging innovator, providing leading products and services to not only healthcare customers, but to the photographic and graphic communications markets. With sales of $14.3 billion in 2005, the company is committed to a digitally oriented growth strategy focused on helping people better use meaningful images and information in their life and work.Consumers use Kodak’s system of digital and traditional image capture products and services to take, print and share their pictures anytime, anywhere; Businesses effectively communicate with customers worldwide using Kodak solutions for prepress, conventional and digital printing and document imaging; and Creative Professionals rely on Kodak technology to uniquely tell their story through moving or still images.
For more information about Kodak’s Health Group, contact your Kodak representative or visit www.kodak.com/go/health.
KODAK and DIRECTVIEW are trademarks of Eastman Kodak Company. 2006
This news item was released on 2006-12-20. Please make sure to visit the official company or organization web site to learn more about the original release date. See our disclaimer for more information.
(c) PressZoom.com - Press Release Distribution Service - All Rights Reserved