ROCKVILLE, Md--The FDA has approved a new computer system, the M1000
ImageChecker, made by R2 Technology, Inc., Los Altos, California, to
aid radiologists in reviewing mammograms. Studies show that use of
the device improved the radiologists detection rate from
approximately 80 out of 100 cancers to almost 88 out of 100.
ImageChecker uses a laser beam to convert the mammographic image into
a digital signal. The signal is processed in a high-speed computer to
identify suspicious areas, which are then highlighted with markers on
a video display of the mammographic image. The radiologist, who has
already reviewed the mammo-gram in the conventional manner, then
looks at the suspicious areas highlighted by ImageChecker and reviews
those same areas on the original mammogram to see if any escaped
notice, and, if so, whether they require further evaluation.
FDAs approval of ImageChecker was based on data from clinical
studies and the recommendation of the Radiological Devices Panel of
FDAs Medical Devices Advisory Committee.