CADx gains approvable letter:
This article was originally published in Clinica
Executive Summary
CADx Medical Systems looks set to become the second firm to gain US approval to sell its computer-aided detection (CAD) system for use with mammography, after the company received an approvable letter from the FDA for its Second Look CAD product. Marketing clearance for the device is subject to final labelling discussions with the FDA. A competing firm, R2 Technology, gained FDA approval for its mammography CAD product, ImageChecker, in 1998.