FDA Approves ImageChecker Computer System

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.

FDA’s approval of ImageChecker was based on data from clinical studies and the recommendation of the Radiological Devices Panel of FDA’s Medical Devices Advisory Committee.