Digital mammography is preparing to enter a new phase with the development and testing of a generation of products capable of generating thin-slice volumetric views of the breast. But tomosynthesis is only part of a rapidly evolving picture. Computed radiography developers are getting ready to commercialize systems that will compete with the current generation of digital mammography systems, which themselves are being outfitted with enhanced features to improve image quality and efficiency and new designs to better accommodate patients.
The Women's Care Solution from Agfa HealthCare encompasses a full range of analog and digital imaging technologies from acquisition to reporting. Under the Embrace product line, which is commercially available outside the U.S., the company offers a CR system for mammography built on the same platform of digitizers it employs for general radiography. CR mammography is an add-on application using new software and a CR plate that addresses the high-resolution requirements of mammography. A flat-panel option offers direct conversion digital acquisition. CR and flat-panel imaging can share the same data and image management systems, which include a multimodality workstation and PACS integration.
Recognizing the need for mammography programs to increase efficiency and streamline workflow, Cedara Software targets its products at productivity. Central to the company's Breast Imaging Suite is the Cedara I-ReadMammo workstation, which can be part of a stand-alone dedicated mammography solution or integrated into an existing PACS.
A development stage company, DOBI Medical International is working to improve the diagnosis of high-risk and malignant breast disease by identifying abnormal vascularization associated with tumors. DOBI stands for dynamic optical breast imaging, which is highly sensitive to the differential light-transmitting properties of abnormal vascularization when an external pressure stimulus is applied. The company is selling its ComfortScan system outside the U.S., and it has begun clinical trials in anticipation of submitting the product to the FDA.
An upgrade brings mammography capability to Kodak's DirectView CR 850, CR 950, and CR 975 systems. Currently available in Asia, Europe, and Latin America, the DirectView mammography feature is being tested in clinical trials prior to submission to the FDA for approval for sale in the U.S. Also new and shown at the 2005 RSNA meeting were mammography software enhancements to the CareStream radiology information system platform.
After submitting the final module of the premarket approval application for its CR for mammography system in June, Fujifilm Medical Systems USA planned to launch the FCRm (Fuji computed radiography for mammography) product at the RSNA meeting. Approval was not received, however, as expected. The technology was shown instead as a work-in-progress. Joining the pending product was another work-in-progress, a single-plate CR mammography image reader.
GE Healthcare is incorporating a larger detector in its new work-in-progress full-field digital mammography system. The 24 x 30.7-cm amorphous silicon cesium iodide detector promises to significantly increase detective quantum efficiency (DQE), increase patient comfort, and improve ergonomics, particularly when imaging large-breasted women. The company is also offering mammography systems with its standard-size detector, which is around 19 x 23 cm, to accommodate high-volume breast imaging centers that may wish to have separate suites for scanning smaller breasted women. GE's prototype digital breast tomosynthesis system is being designed so it can be seamlessly integrated into existing practices without decreasing productivity.
Giotto distributes analog and digital mammography systems with a unique design. Developed and built by Italian manufacturer Internazionale Medico Scientifica, Giotto mammography units have a circular gantry that allows patients to be positioned facing the technologist. Without a vertical column, the mammography machines image patients on an incline, which reduces the pain associated with breast imaging by permitting less compression, images close to the chest wall, and minimizes or eliminates work-related injuries. With no vertical column between them, the design also fosters communication between patient and technologist. More than 1500 analog systems have been installed worldwide, including one at the University of California, San Diego, and 30 full-field digital mammography products have been sold outside the U.S. The full-field mammography system has not yet been approved for sale in the U.S. Giotto anticipates it will receive premarket approval for its digital mammography system in 2006.
Months after acquiring mammography intellectual property rights for the MammoTest stereotactic breast biopsy system from Fischer Imaging, Hologic is poised to take over the lion's share of the market for breast biopsy tables. Although Hologic also gained the rights for Fischer's SenoScan digital mammography technology, it is not expected to incorporate the slot-scan mammography technology into its digital mammography product line, which relies on a selenium flat-panel detector. At the 2005 RSNA meeting, Hologic displayed its full-field digital mammography system as well as the second-generation version of its prototype 3D breast tomosynthesis unit and advancements in mammography workstations.
Adopting a new technological approach to mammography, Konica Minolta Medical Imaging USA introduced a phase-contrast mammography system that magnifies edge effects from x-ray refraction to sharpen contrast at the edges of the breast and enhance the visualization of microcalcifications and fibrils within the breast. The Regius PureView Mammography System, shown at the 2005 RSNA meeting and pending FDA approval, combines phase-contrast mammography technology with CR to produce digital mammography images with the same resolution as screen-film images.
Available outside the U.S., Philips' Mammography Solutions is an intuitive and customercentric portfolio of products that includes the MammoDiagnost FD Eleva digital mammography system, MammoDiagnost film-based product, and the EasyVision Mammo workstation. All mammography systems can be programmed with image processing Unique software.
A global marketer of a range of mammography products, including a product line designed to meet the needs of high-volume fixed or mobile breast imaging sites, Planmed highlighted its Nuance direct digital mammography offering.
Just a year after introducing the Mammomat Novation as a marketable product, Siemens is following the lead of GE Healthcare and Hologic and developing a prototype version of digital breast tomosynthesis. Introduced at the RSNA meeting, the digital breast tomosynthesis system is based on Siemens' Mammomat Novation full-field digital mammography system. Also shown at the RSNA meeting was new image processing software that reconstructs breast images obtained from full-field digital mammography as well as ultrasound and MRI to clarify for radiologists some of the most difficult breast scans to interpret, including lesions in dense breasts and microcalcifications.