R2 v. ISSI
This article was originally published in The Gray Sheet
Executive Summary
Intellectual property suit charges Intelligent Systems Software, Inc. with infringing three patents covering the ways in which R2 devices scan, process and display images. PMA-approved by FDA in 1998 for use with film-based screening mammography to assist radiologists in minimizing false readings, R2's ImageChecker received an expanded indication for diagnostic mammograms in 2001. In April, the agency approved R2 CAD technology for use with the GE Senographe full-field digital mammography system. ISSI's MammoReader was PMA-approved for "identifying areas on the original mammogram that may warrant a second review" in January, preceding film digitizer Howtek's acquisition of the firm in February (1"The Gray Sheet" Feb. 25, 2002, p. 8)...