FDA Approves First Device to Recheck Mammograms

The government on Monday approved the first computerized scanner to double-check mammograms for signs of cancer that radiologists may have missed.

The ImageChecker promises to help improve the accuracy of mammography reading, thus helping to catch breast tumors earlier when they’re more treatable.

“There’s always the possibility the radiologist will overlook something important,” said Dr. Matthew Freedman of Georgetown University, which is researching similar technology. “This is the check on the radiologist to know, ‘I’ve not missed anything.’ . . . Radiologists will use this and like it.”

Just how helpful the ImageChecker will be is still up for debate. The Food and Drug Administration estimates the device could increase a radiologist’s accuracy from detecting 80 of every 100 cancers to catching 88 of 100.

The manufacturer, California-based R2 Technology Inc., predicts that for every 100,000 cancers easily caught by mammograms, the ImageChecker would help diagnose 12,800 more patients. Those are women whose cancer might not otherwise be found until they return for the next year’s mammogram, time enough for a tumor to double in size, said Alan Stein, R2’s vice president.

The FDA cautioned that it’s not yet clear if the new ImageChecker also will increase false alarms over benign lumps. It ordered R2 Technology to immediately begin studying that.

But the government considered the device important enough for a fast-track review, and radiologists said the nation’s shortage of experienced mammographers means there’s a strong need for a way to double-check women’s exams.

Most U.S. mammograms “are not read by real experienced people,” said Dr. Richard Reitherman, mammography chairman for the American Cancer Society of Southern California. The ImageChecker “is a definite benefit” for those clinics.

American women undergo about 30 million mammograms every year. The breast X-ray is the gold standard in detecting breast cancer, particularly early tumors.

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But mammograms aren’t foolproof. For every 80 breast cancers that mammograms diagnose, 20 are missed, the FDA estimated.

The computer system will cost about $175,000. No one knows how much clinics will charge for rechecked mammograms. Mammograms today range from $40 to $150.

Studies show simply having a second radiologist reread all mammograms would be just as accurate, said Dr. Edward Sickles of UC San Francisco, speaking for the American College of Radiology. But very few mammography clinics have the time or money to do that--insurers don’t pay for it, he said.