May 23, 2006
Anson Proposes Digital Mammography Reclassification
Colleen Hittle Densmore, RAC, Managing Partner, presented evidence to the FDA Radiological Devices Panel to propose the reclassification of full field digital mammography (FFDM) systems from Class III (PMA) to Class II (510(k)) devices. Digital mammography systems are comparable and sometimes superior in cancer detection in some populations and improve efficiencies by eliminating the conventional tasks of film processing, storage, copying and retrieval, and potentially reduce recall and repeat screening as digital review allows for magnification and less technical manipulations from acquisition to film output. A copy of the slide presentation is available by downloading FDA Proposal: Full Field Digital Mammography Systems.
