Hologic
Hologic’s Lorad division will highlight two work-in-progress FFDM units, one based on CCD technology -- which received an approvable letter from the FDA on October 25 -- and another based on amorphous selenium flat-panel technology from subsidiary Direct Radiography.
Hologic will emphasize amorphous selenium’s superior modulation transfer function (MTF) and detective quantum efficiency (DQE) measurements compared to film-screen and other types of digital mammography units.
The Danbury, CT, company will also highlight its analog mammography products, including its M-IV series with Lorad’s High Transmission Cellular (HTC) Grid, and its new mid-range line of products, Affinity.
Imaging Diagnostic Systems
Plantation, FL-based Imaging Diagnostic Systems (IDSI) will highlight its computed tomography laser mammography (CTLM) system at the RSNA show. The unit, which the company defines as an adjunctive technology to mammography, carries an integrated array of 168 detectors, and a laser beam that rotates around the breast to create 3-D tomographic images with no breast compression. The company will highlight its work on the use of CTLM with fluorescent compounds that will target particular cancer cells and fluoresce in the presence of those cells.
CTLM has earned a CE Mark in Europe, and received export certification from the FDA in September of this year. The FDA has also given IDSI permission to place up to 10 CTLM units at clinical sites under its investigational device exemption (IDE) program. Currently, IDSI has CTLM in clinical trials at the University of Virginia in Charlottesville, VA, and at Nassau County Medical Center in East Meadow, NY.
IDSI has completed the feasibility portion of the FDA’s premarket approval (PMA) process for CTLM, and has submitted four of five modules necessary for clearance under the FDA’s modular submission protocol.
Instrumentarium Imaging
Instrumentarium will also highlight CAD technology. The company signed an agreement with Intelligent Systems Software in September to exclusively distribute the Boca Raton, FL, firm’s work-in-progress MammoReader in the U.S. MammoReader is under review by the FDA.
Instrumentarium will also display the latest upgrades to its Delta 32 stereotactic breast biopsy device, cleared by the FDA this summer. The new version easily handles the newest generation of J&J Ethicon’s Mammotome biopsy product, according to Mike Palazzola, Instrumentarium’s president. It also includes the company’s tuned-aperture computed tomography (TACT) software, which allows clinicians to view breast tissue layer by layer in a 3-D image. The FDA cleared TACT in 2000.
Also in the Milwaukee company’s booth will be partner Dilon Technologies’ gamma camera for breast imaging, and Instrumentarium’s work-in-progress Delta DX, an FFDM system that uses flat-panel amorphous selenium detectors.
Intelligent Systems Software (ISSI)
This Boca Raton, FL, company will be making its RSNA debut with MammoReader, a work-in-progress CAD workstation. ISSI filed a PMA application for MammoReader in October, and the company says it will offer the system at half the price of other CAD workstations on the market.
ISSI claims that MammoReader searches for all of the primary signs of breast cancer, including spiculated lesions, well-defined and ill-defined masses, architectural distortions, asymmetry, and clustered microcalcifications. The system can process about 96 mammograms in an eight-hour shift, the company said.
Mirada Solutions
RSNA newcomer Mirada Solutions will debut a CAD workstation that uses the company’s proprietary standard mammogram form (SMF) software package, called Ridgex. Mirada was formed in July to commercialize technologies developed at Oxford University in the U.K.
Ridgex enables the direct comparison of data sets captured by MRI, CT, and PET. Mammograms can vary widely in appearance, even when the same operator uses the same machine. To eliminate this variation, Ridgex uses algorithms to extract quantitative diagnostic parameters from data sets compiled by 3-D scanning. The resulting images provide physicians with an objective review of the images’ contents.
In its RSNA booth, Mirada will demonstrate Ridgex, the SMF CAD workstation, and a mammography training tool based on Ridgex. The VirtualMammo training tool shows clinicians and technologists how imaging parameters change mammogram images. The company’s SMF-based CAD systems detect more cancers and give fewer false positives than other systems, according to Mirada CEO Ralph Highnam.
Mirada is working with distributors and partners to bring SMF-related products to market, particularly CAD systems that enhance breast cancer detection.
Planmed
In its RSNA booth, Finnish mammography firm Planmed will highlight a number of works-in-progress, according to Vesa Mattila, vice president of sales and marketing.
These include an FFDM unit based on slot-scanning technology; an anatomically adaptable automatic exposure control for mammography called Flex-AEC, which adjusts individual sensor sensitivities according to breast tissue composition; a digital spot and stereotactic unit called DigiGuide, which is upgradable to all of the company’s other units; and a battery-operated version of its Sophie Classic Mobile unit.
The Addison, IL, company will also showcase its MaxView breast positioning system, which is now available for the firm’s mobile mammography devices. MaxView images up to 2 cm more breast tissue in all views compared to conventional mammography devices, according to Planmed.
R2 Technology
At this year’s show, CAD developer R2 Technology will highlight improved algorithms on its ImageChecker product. The algorithms increase the unit’s accuracy and sensitivity, according to the company.
R2 will also discuss a new interactive touch-screen that will display more information on the abnormalities detected by the unit. Users will be able to touch a marked feature on the screen and ImageChecker will magnify the area, according to Sandra Stapleton, director of clinical marketing.
The Los Altos, CA, company has been busily working to expand ImageChecker’s uses: In June, the firm received clearance from the FDA to expand the unit’s indications to include diagnostic mammograms. ImageChecker was previously approved for use only with routine screening mammograms.
R2 will also highlight an upgrade path for using ImageChecker with FFDM units, for which it has submitted a supplement to its PMA with the FDA, Stapleton said. On the R&D side, R2 Technology will showcase its work on developing CAD technology to detect lung nodules on CT exams.
Scanis
Scanis will introduce Version 1.4 of its Mammex TR mammography CAD system. The new version offers faster processing times, reduced false-mark rates, multiple language capability, and a friendlier user interface. Mammex TR uses a rule-based algorithm rather than neural networks, and has the CE Mark and Canadian Medical Device License.
Mammex TR is currently moving through the FDA’s approval process, according to CEO Robert Chapman. Under the agency’s modular submission protocol, Scanis will submit three modules for Mammex TR, and the company plans to move forward on further clinical trials for Mammex TR to develop data from its preclinical work submitted to the FDA. Five institutions in the U.S., including the University of Southern California in Los Angeles, and two in Europe, will participate in these further clinical evaluations.
Sectra Imtec
Following up on the unveiling of its work-in-progress MicroDose Mammography FFDM system at last year's RSNA meeting, Swedish firm Sectra Imtec will display MDM in use with a gantry, workstation, and miniPACS.
The Linkoping-based firm is set to begin formal clinical testing of MDM in early spring 2002, with an eye on pursuing the PMA process with the Food and Drug Administration next year.
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Advanced Diagnostics through Fuji
By Kate Madden Yee, Erik L. Ridley, Jonathan S. Batchelor, and Leslie Farnsworth
AuntMinnie.com staff and contributing writers
November 14, 2001
Copyright © 2001 AuntMinnie.com
