Kodak receives FDA approvable letter

Eastman Kodak Health Imaging has received a U.S. Food and Drug Administration approvable letter for its mammography computer-aided detection (CAD) device, according to the Rochester, NY-based vendor. An approvable letter is a precursor to receiving final FDA marketing approval on a new product providing that certain criteria, such as a good manufacturing practices (GMP) review, is met.

The company plans to offer CAD software as a stand-alone product and as a component of its digital capture and image-and-information management systems, Kodak said.

By AuntMinnie.com staff writers
November 11, 2003

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