FDA approves 3-D mammography system
The first X-ray mammography device that provides 3-D images of the breast has received FDA approval for breast cancer screening and diagnosis.
The Selenia Dimensions System is manufactured by Hologic Inc., and is an upgrade to the company’s current FDA-approved 2-D system. The upgraded system can provide 2-D and 3-D X-ray images of the breast.
“Physicians can now access this unique and innovative 3-D technology that could significantly enhance existing diagnosis and treatment approaches,” Jeffrey Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in an agency press release.
Approval is based on results from two studies that demonstrated that when compared with viewing 2-D images alone, viewing 2-D and 3-D images improved a radiologist’s ability to distinguish between cancerous and non-cancerous cases by 7%. In the studies, radiologists viewed 2-D and 3-D images from more than 300 mammography exams.
Although the combination of the system’s 2-D and 3-D images approximately doubled the radiation dose the patient received, it improved the accuracy with which radiologists detected cancers, decreasing the number of women recalled for a diagnostic workup, according to the release. There is uncertainty for radiation risk estimates; however, the increase in cancer risk from having a 2-D and 3-D exam is expected to be less than 1.5% compared with the natural cancer incidence and less than 1% compared with the risk from conventional 2-D mammography.
According to the Mammography Quality Standards Act, all health care professionals must obtain 8 hours of training before using new mammography technology on patients. In addition, the FDA requires that the manufacturer provide each facility with a manual clearly defining the tests required for initial, periodic and yearly quality-control measures.
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