Regulatory news: Kodak
Eastman Kodak Company has filed its submission with Health Canada for approval of its computed radiography (CR) system for mammography in the country. The 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 has submitted the final module of a pre-market approval submission (PMA) to the U.S. FDA for approval of the system. Meanwhile, the system is already available for sale 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.