A variety of new breast imaging technologies debuted and gained new strength at RSNA 2003. The modalities stretched from traditional mammography to digital mammography, breast ultrasound, breast MRI and even a new technology joined radiology's vocabulary - Somography, which is an ultrasound image configured to look like a mammogram.
GE Medical Systems at RSNA touted its added strength via the recent Instrumentarium acquisition, showcasing the Diamond film-screen system, which can be upgraded using digital stereo, digital spot, and 3-D capability with Instrumentarium's tuned-aperture computed tomography (TACT) technology.
GE also showed a new works-in-progress version of its amorphous silicon-based FFDM system, Senographe DS, featuring a motorized gantry and a smaller tube head. The system uses the same molybdenum/rhodium tube from the Senographe 2000D.
GE also debuted as a works-in-progress a new workstation, the Seno Advantage multimodality breast imaging workstation. Seno Advantage, which gained FDA clearance in mid-December, allows users to view ultrasound, mammography, MR, and PET/CT images.
Hologic, Inc. at RSNA previewed add-on hardware and software breast tomosynthesis for its first full field digital breast tomosynthesis research system. The works-in-progress technology for the Lorad Selenia brings the promise of a full volume of data produced at the same radiation dose as a conventional screen-film or digital mammogram.
Breast tomosynthesis allows a series of images in slices of 1 mm or less (usually 11 images over a 30 degree range) to be acquired and reconstructed for 3D viewing. Hologic says the technology has the potential to reduce or eliminate overlapping tissue, which can obscure a breast lesion. Tomosynthesis may also provide improved diagnostic information, with reduced breast compression. The technology will be offered as an add-on to Hologic's Lorad Selenia full-field digital mammography system.
Cumming says an FDA filing is expected in 2004.
Eastman Kodak Co. promoted several works-in-progress products for mammography, including computer-aided detection (CAD) software, a mini-PACS and expanded mammography printing capabilities for its DryView 8900 laser imaging system. All three products are set for launch in 2004.
The CAD technology is courtesy of Kodak's September 2003 acquisition of MiraMedica Inc. Kodak received an approvable letter from the FDA for the CAD technology and is about to commence clinical studies with the technology.
A works-in-progress PACS for mammography to manage and store images from a full-field digital mammography system will include diagnostic workstations optimized for reading mammograms. The technology will be designed for a small mammography center or within a full PACS.
Speaking of FFDM, Kodak Health Imaging President Dan Kerpelman says a FFDM system is in the company's future, but it may not be until 2005.
Kodak also is working on a software upgrade to its DryView 8900 laser imaging system to print high-resolution mammography images onto DryView mammography laser imaging film. Images would be available in 8-by-10 inch or 10-by-12 inch sizes.
Kodak also introduced a new mammography screen-film system for enhanced visualization (EV) of abnormalities in breast tissue. Kodak says its MIN-R EV is an upgrade from its MIN-R 2000 screen-film system.
Sectra Imtec's works-in-progress Sectra MicroDose Mammography digital system offers a five-fold reduction in radiation compared to traditional film-based systems, the company says. The unit's flat panel detector, made by Stockholm, Sweden-based Mamea Imaging AB, features new photon counting technology that allows higher efficiency (95 percent) and higher patient volumes. The system, which is currently available for sale outside of the U.S., includes the Sectra PACS for processing and archiving digital mammography images.
Sectra's first installation at Helsingborg Hospital Breast Disease Center in Sweden is being used to screen more than 60 women per day, on a normal work schedule.
The first U.S.-based unit is slated to be installed at the University of North Carolina-Chapel Hill in February or March, according to Hakan Eriksson, marketing manager mammography. Sectra hopes to submit its FDA 510(k) filing in 2004.
Siemens Medical Solutions is currently awaiting the approval of its Pre-Market Approval Application for both the Mammomat NovationDR, a full-field digital mammography system, and the MammoReportPlus