Mammography vendors build upon newfound alliances, aquisitions

Although late to relinquish its reliance on film, mammography is beginning to enjoy the fruits of digital technology. Mammography manufacturers are adding automated analytical tools to improve breast cancer detection and enhance workflow. They are also showing high-resolution multimodality workstations to allow side-by-side comparisons of breast images captured with ultrasound, MR, and CT as well as mammography. Visible on the horizon is volumetric breast tomosynthesis.

Fischer Imaging

A leader in women's health, Fischer Imaging was a pioneer of digital technology in mammography. The company commercialized one of the first digital stereotactic biopsy systems and followed with the introduction in 2001 of its SenoScan TrueView digital scanning mammography system. Standard capabilities onboard the SenoScan include patented slot-scanning technology, which allows an industry best 25-micron native resolution and reduced x-ray dose, as well as curved breast support for patient comfort. Fischer has since added computer-aided detection capabilities and is developing a high-resolution flat-panel display for its digital mammography review workstation.

• After receiving approval from the FDA weeks before the RSNA meeting, Fischer will begin integrating the CADx Second Look CAD system for digital mammography into the SenoScan TrueView product. Second Look allows radiologists to observe in real-time CAD marks that reflect subtle changes in breast tissue consistent with cancer.
• Only days before the RSNA meeting, Fischer inked an agreement with iCAD to include the company's new CAD technology, called iAD, in SenoScan TrueView. The iAD offering, which was recently approved by the FDA, brings CAD to breast imaging centers that provide traditional film and digital mammography screening. The agreement expands upon a previous arrangement between the two companies to integrate iCAD's iDM digital CAD system into the SenoScan.
• Armed with a recently awarded $1.2 million fast-track Small Business Innovation Research grant from the National Cancer Institute, Fischer will be working with IBM to develop an advanced 9-megapixel display that incorporates the IBM T221 flat-panel unit into the SenoScan review workstation. The T221 has a resolution of 3840 x 2400 pixels and a 25% larger viewing area than current high-resolution CRT monitors. It is also thinner, has a longer life expectancy, and generates less heat than conventional 24-inch CRTs. Shown as a work-in-progress, the workstation could be submitted to the FDA for clearance by the end of 2004.

GE Medical Systems/Instrumentarium Imaging

At the first major radiology meeting since the Oct. 9 acquisition of Instrumentarium Imaging, GE Medical Systems showcased its expanded portfolio of mammography products, which comprises all commercially available mammography systems from the two companies. Included is stereotactic capability across all levels of Instrumentarium's film-based line.

• GE engineers are trying to migrate certain high-performance features from the Instrumentarium Diamond into the Senographe 2000D. The ParkBack Tube can be moved out of the way to increase patient comfort during breast positioning and at the same time reduce repetitive stress for technologists. AutoPoint automatically selects among eight discrete detectors at the beginning of an exposure. Another key aspect of the Diamond system that might be migrated to Senographe 200D is Tuned Aperture CT (TACT), which reconstructs 3D images from seven digitally acquired 2D scans of different angles of the breast for spot diagnostic mammography. TACT works to improve cancer detection and eliminate unnecessary biopsies by targeting breast lesions more accurately.
• Senographe De/Esse digital unit is an early manifestation of the meshing of technologies developed by the two companies. The work-in-progress incorporates the ergonomics and motorized gantry from Instrumentarium's product line in a new compact platform with automatic preset displays of angle and dose, a pivoting acquisition workstation, and digital stereotactic capability. Undergoing clinical evaluation, the product is expected to become commercially available by mid-2004.
• GE is optimizing the design of the breast tomosynthesis image acquisition unit as well as its reconstruction algorithms based on development work done in collaboration with Massachusetts General Hospital (SCAN 12/24).
• Seno Advantage, which evolved from GE's Advantage Workstation, is a multimodality breast imaging review workstation. Two high-resolution gray-scale monitors are provided to support full-field digital mammography and one color monitor to display multimodality images and other applications. Utilizing Advantage Workstation 4.2 software, Seno Advantage can export images to a CD or create electronic films for archiving or remote viewing. CAD assists in the detection of lesions. Premium View, which was available on previous workstations, optimizes images across the breast regardless of density differences.
• The Instrumentarium Alpha RT, although not shown on the convention floor, is being positioned as a value-oriented product for budget-conscious customers. The efficient, low-maintenance Alpha has a lightweight ergonomic C-arm, VectorPoint Photocell method for correctly positioning the detector, and synchronous grid/exposure movement.

Hologic

With the idea of providing a suite of breast imaging products that extends beyond x-ray-based acquisition systems, Hologic has added capabilities in ultrasound and breast MR, while enhancing breast biopsy and CAD capabilities. At the RSNA meeting, the company unveiled the results of collaborative agreements with Aloka, R2 Technology, Confirma, and Suros, each of which were negotiated over the last six months. The highlight of the show was the breast tomosynthesis add-on for the Selenia full-field digital mammography system.

• The digital tomosynthesis attachment for the Selenia full-field digital mammography system, which is currently available only as a research unit, acquires multiple images at several angles during a five to 10-second scan and then reconstructs the images in 3D slices. The tomosynthesis unit attaches to the Selenia gantry, completing a 10-second scan over a 15 degrees range. The scan generates 50 slices, each one a millimeter thick. Reconstruction is completed in 30 seconds.
• A work-in-progress workstation is based on a Windows platform and has a touchscreen as well as a three-megapixel, high-resolution monitor.
• Under the terms of a Nov. 11 agreement, Aloka and Hologic are manufacturing a high-performance diagnostic ultrasound system that includes Aloka's proprietary ProSound package of enhancements, such as Digital Pure Beam imaging, tissue harmonic echo imaging, 3D color Doppler, a 12-bit AD converter for greater contrast resolution, and integrated DICOM-compatible image management. The three-year agreement gives Hologic the exclusive right to distribute customized diagnostic ultrasound products for breast imaging.
• Six months after agreeing to develop and distribute a customized version of R2 Technology's ImageChecker CAD system for the Selenia full-field digital mammography system, Hologic is releasing the product for FDA approval. The company is already selling R2 Technology's analog CAD system.
• Alongside its digital mammography CAD capability through R2, Hologic is developing an MR CAD option with Confirma. On the basis of a Nov. 20 agreement, Confirma is integrating its CADstream MR breast system to function with the full-field digital Selenia and provide simultaneous mammography and breast MR viewing capability in the same plane.
• To present and future users of its screen-film and digital mammography systems, Hologic is offering mammography information tracking and reporting tools from Mammography Reporting Systems. Through an agreement announced Nov. 25, Hologic and MRS will cooperate to provide such tools as radiologist exam reports, medical audits, and practice management statistical reports.
• A nonexclusive agreement gives Hologic the right to distribute the Suros automated breast biopsy and tissue excision system (ATEC). ATEC is being bundled with Hologic's MultiCare Platinum and StereoLoc II stereotactic and advanced digital imaging system for breast biopsy.

Siemens Medical Systems

The German multimodality company has targeted breast imaging innovations in x-ray mammography. At the RSNA meeting, the company displayed products introduced earlier in the year, as well as technologies still in the pipeline.

• Novation, which is under review at the FDA, contains high-performance features including a pivoting bucky and a full-field amorphous selenium detector.
• MammoReportPlus, a dedicated mammography workstation, has a roam/pan function that facilitates access to full spatial resolution and allows switching between eight-view mammography studies in less than a second.
• A tungsten-based tomosynthesis unit is being designed for unenhanced and contrast-enhanced 3D breast imaging. The system is being developed in conjunction with Duke University Medical Center.