Eastman Kodak Health Group said it has submitted the final module of a premarket approval (PMA) submission to the U.S. Food and Drug Administration for approval of its computed radiography (CR) system for mammography applications.
The Rochester, NY-based vendor reported that the final module contains data and test results from the clinical trials it has concluded at sites in the U.S. and Canada. The FDA has already accepted and closed review of the previously submitted modules covering manufacturing information and nonclinical data, Kodak said.
The product is already being sold in Europe, Asia, Japan, and Latin America, according to Kodak.
By AuntMinnie.com staff writers
November 9, 2006
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