Second Look gets FDA nod
CADx Medical Systems can now market its Second Look CAD product in the U.S., following FDA approval of the system. The subsidiary of Shire Pharmaceuticals Group is preparing to market the product to hospitals, clinics, and
CADx Medical Systems can now market its Second Look CAD product in the U.S., following FDA approval of the system. The subsidiary of Shire Pharmaceuticals Group is preparing to market the product to hospitals, clinics, and mammography centers across the U.S. The decision follows receipt by the company Nov. 21 of an approvable letter from the regulatory agency. Second Look is based on imaging algorithms used by the U.S. military to automatically recognize targets. Approved for both screening and diagnostic use, Second Look will be marketed to radiologists as a tool for highlighting the most critical masses and microcalcifications on mammograms. Clinical trials demonstrated that 26.2% of lesions otherwise missed could be detected with Second Look.