CADx gets approvable letter

Another developer of computer-assisted detection systems may be close to entering the market. CADx Medical Systems of Quebec has received an FDA approvable letter for its CAD mammography system. Final approval would clear the way for the company to sell its film-based Second Look product in the U.S. Only the company's combination film digitizer and image report generator would be allowed to enter the U.S. market. Software packages that the company is developing for integration with digital mammography systems from Fischer Imaging and Hologic would not be affected. CADx has been selling Second Look overseas for close to a year. About 25 systems have been installed in more than a dozen countries. List price outside the U.S. is $169,000.