CAD stands poised to expand

The FDA has approved a version of R2 Technology's ImageChecker CAD technology customized for use on Hologic's Selenia full-field digital mammography system. The approval finalizes the commitment by the two companies to merge their technologies under the terms of a five-year agreement signed in July 2003. Hologic has exclusive worldwide distribution rights to sell the customized product in combination with Selenia, as well as distribution rights for R2 CAD products for use with conventional film-based mammography systems that can be upgraded to digital mammography systems. The FDA initially approved ImageChecker in 1998 for use with film-based screening mammography, expanding its approval in 2001 to include use with diagnostic mammograms.

In early April, the agency issued an approvable letter to R2 for the company's ImageChecker CT Lung Nodule CAD system. ImageChecker CT is the first CAD system to receive an approval recommendation from an FDA Advisory Panel (SCAN 2/25/04) and an approvable letter for the detection of suspicious lung nodules using CT as an imaging modality. Last month, a panel of leading radiologists at the European Congress of Radiology concluded that this new CAD application could provide a substantial advance in detection of suspicious lung nodules. Early clinical studies demonstrated improved performance by radiologists using the technology, according to the panel.