CADx to distribute CAD system in 14 countries
CADx Medical Systems of Montreal has signed distribution agreements for its Second Look CAD mammography system that cover 14 countries. It will be available in the U.S. when it gains FDA approval. CADx will file for FDA premarket approval after
CADx Medical Systems of Montreal has signed distribution agreements for its Second Look CAD mammography system that cover 14 countries. It will be available in the U.S. when it gains FDA approval.
CADx will file for FDA premarket approval after clinical trials, which are under way at 11 U.S. sites, are complete. The newly signed distributorships are in Australia, New Zealand, Spain, Germany, Portugal, the U.K., Ireland, Belgium, Luxembourg, France, South Korea, Poland, Singapore, and Malaysia.
After a patients mammography film has been fed into a digitizer, Second Looks software analyzes it using proprietary algorithms. Second Look produces a printed paper image, highlighting areas of potential concern. Radiologists can use the printed image to assist with a diagnosis.
R2 Technology of Los Altos, CA, markets a similar CAD system known as the ImageChecker. GE Medical Systems plans to integrate ImageChecker into its Senographe 2000D as soon as it gains FDA clearance to read soft-copy images. Senographe has approval only for hard-copy reads.