Mammograms The FDA has approved a new computer system that will call attention to parts of a mammogram image that are suspicious. The device has the potential to reduce the number of women who have delayed diagnosis of breast cancer due to missed abnormalities in screening mammograms. Studies showed improved detection rates from approximately 80 out of 100 cancers to almost 88 out of 100. ImageChecker scans mammograms with a laser beam to convert the image into a digital signal. The signal is processed in a high-speed computer to identify possible signs of cancer.
Video monitors display the mammographic images, with markers highlighting suspicious areas.
With the ImageChecker, the radiologist first reviews the mammograms in the conventional manner, then activates ImageChecker and looks at the suspicious areas highlighted on the monitors. In the US, for every 80 cancers currently detected through routine mammogram screening of healthy women, an estimated 20 additional cancers are missed and not found until later. FDA 's approval of ImageChecker was based on data from clinical studies in which more than 40,000 mammograms were reviewed. An NDA is forthcoming in 3Q 1998. Two Boston institutions have been issued three patents for technology which allows the insertion of human cells into the body to grow into new organs.