CADx Systems receives FDA OK for CADx Continuum Software

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

The FDA has given clearance to CADx Systems Inc. to market its Second Look Version 6.0 computer-aided detection (CAD) software.

 With the FDA approval, CADx said that the agency approved claims of up to 96.2 percent overall sensitivity and specificity as low as 1.6 false positives (FP) per case in the use of CADx's CAD technology in finding breast cancer.

 CADx said the design of the Second Look platform enables the version 6.0 CAD software to operate at multiple sensitivity points, providing a radiologist with a selectable range of sensitivity and specificity appropriate to their clinical setting. This new software release also provides the user with a choice of three operating points, one with higher sensitivity, another with lower false marks and a median selection that optimizes sensitivity and specificity.