In two separate decisions, the FDA has approved both the first three-dimensional (3-D) imaging system for mammography and the first diagnostic radiology application for mobile devices.
The Selenia Dimensions System is the first x-ray mammography device to construct 3-D images of the breast for the screening and diagnosis of breast cancer. Although it can provide 2-D images as well, conventional 2-D imaging require approximately 10% of women to undergo additional testing after initial screening for abnormalities that are later determined to be noncancerous. The 3-D mammography system may boost accuracy in the detection and diagnosis of breast cancer.
Clinicians will now be able to view computed tomography (CT), magnetic resonance imaging (MRI), and nuclear medicine images wirelessly through a new mobile radiology application for iPhones and iPads that uses MIM Software. This is the first application that the agency has cleared for viewing such images and making diagnoses based on those imaging techniques. The application is indicated for use only when there is no access to a workstation (www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/). ONA