Kodak gives FDA last batch of clinical data for CR mammo
Eastman Kodak Company has submitted the final module of a pre-market approval submission (PMA) to the U.S. FDA for approval of its computed radiography (CR) system for mammography. This portion of the submittal includes data and test results from the clinical trials Kodak has concluded at several sites in the U.S. and Canada. The FDA already has accepted and closed review of the previously submitted modules covering manufacturing information and non-clinical data. Kodak hopes to obtain regulatory approval to bring its KODAK DIRECTVIEW CR Mammography Feature to market in the U.S. next year. Kodak’s mammography feature already is being sold in Europe, Greater Asia, Japan and Latin America.