Mammography evolves to improve flat-panel imaging, accommodate CR

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.

Agfa HealthCare

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.

• Launched outside the U.S. in 2003, Embrace CR mammography has been installed in 100 to 120 sites in Europe. Agfa is beginning the PMA process to bring the commercial product from the European market to the U.S.

• The DM1000 direct conversion digital acquisition mammography system consists of a flat-panel digital detector, user-friendly positioning unit, and advanced technology acquisition station. It is currently available in Europe - including Scandinavia - and Russia.

Cedara Software

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.

• I-ReadMammo offers a number of productivity tools, including simultaneous review of breast imaging studies obtained with different modalities, automatic image display, and customized viewing sequences. It is designed to support breast ultrasound as well as MR and x-ray mammography. New mammography software allows users to synchronize magnification, pan, and zoom features to capture minute details and navigate through bilateral images. Masking, bright light, and binocular features duplicate hard-copy review techniques to help simplify the transition from analog to digital mammography.

DOBI Medical International

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.

• ComfortScan uses high-intensity light-emitting diodes (LED) and gentle external pressure to highlight areas of abnormal vascularization in the breast. It consists of a CCD camera, soft breast holder, LED illuminators, operator display, and proprietary software designed to visualize angiogenesis and target abnormal vascular beds.

Eastman Kodak

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.

• DirectView CR Mammography has improved image quality by producing high-resolution scans with a 50-micron pixel pitch. The EHR-M screen provides the highest DQE of any Kodak CR screen to increase signal and reduce noise. The exposure latitude of CR and postacquisition image processing provide more consistent quality than conventional imaging.

• New Kodak DirectView CR mammography cassettes allow for image capture close to the chest wall.

• Optional EVP image processing software reduces or eliminates the need to hot-light soft tissue and other overpenetrated areas, reduces the need for windowing and leveling of images presented on a workstation, and adds robust automatic tone scale processing.

• CareStream RIS software for mammography automatically generates letters to patients and requests for annual examinations and incorporates mammography information drawing and annotation features. CareStream PACS can store original images and a single secondary capture mammography image that contains CAD markers for some CAD systems.

• A work-in-progress product automatically justifies different mammographic views and tissue inversion. It also integrates CADstream software from Confirma with Kodak's PACS platform so radiologists can view CAD results from breast MRI examinations.

• CareStream Information Management Solutions meets archiving requirements that are specific for mammography, such as automatic intelligent clinical information life cycle management for large data sets and quick access to previous exams.

Fujifilm Medical Systems USA

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.

• FCRm consists of an imaging and information processor and the ClearView-CS multiplate CR reader, which has been cleared for general radiography. ClearView-CS employs patented dual-side reading technology and 50-micron pixel sampling.

• Suitable for general radiography and pediatric imaging as well as mammography, FCR Profect One is a single-plate CR mammography image system that provides 18 x 24-cm and 24 x 30-cm fields-of-view. FCR Profect One joins FCR Profect CS, a four-cassette slot CR mammography reader, as CR options for sites outside the U.S. Once the product is approved by the FDA, Fujifilm Medical Systems USA will market FCR Profect One as FCR ClearView 1m, a component of the FCR ClearView CSm multiplate system.

GE Healthcare

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.

• The Senographe Essential work-in-progress is a full-field digital mammography unit with features to accommodate imaging large- as well as small-breasted women. The larger detector improves DQE even under very low dose applications and makes it easier for technologists to position women with large breasts for scanning. A paddle that shifts from one side of the detector to another allows comfortable positioning in the mediolateral and oblique projections. The prototype is being tested in clinical trials in the U.S. and Europe.

Giotto USA

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.

• Giotto Image full-field digital mammography, a work-in-progress, is built around an amorphous selenium detector constructed to allow minimal time between exposures. It supports standard mammography and prone stereotactic biopsy.

Hologic

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.

• Selenia full-field digital mammography uses direct capture technology to sharpen images by eliminating the diffusion of light. The system has a single digital detector with a 24 x 29-cm field-of-view for imaging breasts of almost any size, High Transmission Cellular Grid for producing high-contrast images by reducing radiation scatter, and the Smart Paddle for accurate positioning.

• Selenia breast tomosynthesis produces high-resolution cross-sectional 3D images of the breast that can be viewed and manipulated on a workstation to image areas of the breast that are often obscured by overlapping tissue. The initial tomosynthesis unit, which was created as a proof of concept, is being redesigned as a practical product that may be integrated into existing mammography practices.

• SecureView workstation is being developed to accompany the Selenia breast tomosynthesis system. It has biometrics technology to authenticate access by recognized users and automatically display viewing protocols customized to each user's preferences.

• TechMate mammography workstation independently displays prior scans while simultaneously acquiring and reviewing current images. The workstation also instantaneously sends and receives annotations, displays integrated CAD marks, and reviews and manipulates images in keeping with customized interactive tools.

Konica Minolta Medical Imaging USA

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.

• The Regius PureView Mammography System uses a molybdenum x-ray tube with a 100-micron focal spot. The system also selects the optimal combination of x-ray focal spot size, the distance between the x-ray source and the breast, the distance between the x-ray source and the detector, and the sampling pitch of the CR reader, which scans images at 43.75 microns to produce a resolution of 20 line pair/mm. The Regius PureView Mammography System, which was introduced in Japan in February, is being tested in clinical trials prior to submission to the FDA for approval.

Philips Medical Systems

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.

• MammoDiagnost FD Eleva provides a resolution of 50 micrometers in screening mode and 25 micrometers in diagnostic mode and has a large detector capable of imaging breasts of any size.

• MammoDiagnost with the PCR CosimaX cassette reader allows users to transition from conventional to digital mammography.

• EasyVision Mammo has been optimized for improving workflow and workload in screening mammography. It devotes its full screen to displaying images, supports double reading, links with both RIS and PACS, and includes such diagnostic aids as area, length, and angle measurements, editing graphics, and annotations. The workstation may be customized to incorporate automatic default display protocols, personalized toolbars and popup menus, and image display preferences.

Planmed

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.

• Nuance full-field digital mammography uses direct digital acquisition technology with 85-micron pixel size. The system comes with a small- or optional large-area amorphous selenium flat-panel detector. Other options include geometric magnification at 1.6x, 1.8x, and 2x imaging and stereotactic breast biopsy.

Siemens Medical Solutions

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.

• Mammomat Novation uses a tungsten tube to reduce radiation dose and offers digital screening as well as diagnosis and stereotactic biopsy features. The system interfaces with the MammoReport Plus dedicated mammography reading station.

• The Siemens digital breast tomosynthesis system modifies the Mammomat Novation full-field digital mammography system by adding a motorized x-ray tube to acquire image projections of the breast from different angles. It also incorporates a large-area digital detector to increase the speed and quality of image acquisition and accommodate imaging of all breast sizes.

• Capitalizing on the advanced visualization features of Siemens' syngo acquisition workstation, OpView may be used to adjust the display of images to concentrate on areas of high interest, such as the borders of the breast and subtle masses, or to adjust brightness and contrast for optimal display of images. The software decreases the quantum and electronic noise from x-rays that can interfere with the evaluation of suspicious lesions, particularly abnormalities that are low in contrast. An edge enhancement feature enhances high frequencies in an image to increase the visibility of structures such as microcalcifications. In addition to the multimodality Mammomat Novation syngo-based acquisition workstation, OpView may be used with the syngo MammoReport workstation, which incorporates CAD markers from various vendors.