Mammography CAD programs take spotlight at RSNA meeting

Despite continued disappointment at the Food and Drug Administration’s reluctance to clear full-field digital mammography systems, vendors at the RSNA conference were optimistic about the development of digital and other emerging technologies. In particular, computer-aided detection tools developed by companies such as Qualia, R2 Technology, and Scanis permeated the exhibits.

Proof of vendors’ increasing confidence in CAD technology can be seen in the agreements signed over the last year between OEMs and CAD developers. In April, R2 Technology and GE Medical Systems agreed that GE will bundle R2’s ImageChecker with GE’s full-field digital mammography system, Senographe 2000D, once that system has been approved. In November, Scanis and Trex Medical inked a similar agreement, although Scanis’ Mammex TR unit is still pending FDA clearance.

CAD systems weren’t the only alternative mammography imaging devices highlighted at the RSNA conference. Companies such as Imaging Diagnostic Systems and TransScan Research and Development displayed noninvasive technologies to image the breast, using infrared laser light or electricity to image.

Biopsys Medical/Ethicon Endo-Surgery

• This Johnson & Johnson subsidiary based in Cincinnati displayed its Mammotome biopsy system at the RSNA show. The system was highlighted at the booths of other vendors, including Siemens, which emphasized the unit’s connectivity with its Opdima digital spot device, and Trex’s Bennett division, which showcased the compatibility of Mammotome with stereotactic units StereoView and Digital StereoView.

DBA Systems

• Exhibiting for the first time in its own booth, DBA Systems of Melbourne, FL, displayed its 16-bit digitizer, ImagClear M4200, and its work-in-progress ImagClear Mammography Review System. The review system allows physicians to compare digitized analog films or digital images, as well as crop or enlarge images without losing resolution.
• DBA Systems is also working with partners in the U.K. on ProMam, a CAD workstation that the company would offer as an add-on to its review station. The CAD system is still six to eight months from completion, according to Kate Maloney, director of commercial sales.

feinfocus Medizintechnik

• Making its RSNA debut, this Garbsen, Germany-based mammography developer displayed its work-in-progress DIMA (direct magnification) Plus M12 Mammography System, an upright full-field digital mammography unit with a 16 x 12-inch amorphous silicon detector. The company claims DIMA Plus M12 reduces patient exposure to radiation and identifies 60% more microcalcifications than conventional systems. The company expects to begin its clinical investigations with the unit by installing a DIMA Plus M12 in 1999.

Fischer Imaging

• Fischer showcased Mammotest Plus S, a surgical version of its Mammotest Plus breast biopsy table, as well as a work-in-progress ultrasound-guided gantry that will attach to Mammotest Plus S. The company expects to begin shipping the ultrasound gantry by the end of the third quarter of 1999.
• Also highlighted in the Denver vendor’s booth was its full-field digital mammography system, SenoScan. Fischer expects to apply for 510(k) clearance with the FDA at the end of the first quarter of 1999. The company has begun exploring CAD technology to package with SenoScan and has done initial work with CAD developers, including Intelligent Systems, M.D. in Clearwater, FL.

Fuji Medical Systems USA

• Fuji of Stamford, CT, is looking to enter the U.S. market for digital mammography by pursuing breast imaging applications with its computed radiography readers. Fuji CR readers are already being used internationally for mammography applications, and the company is beginning a multicenter clinical trial to support the use of the technology in the U.S. Fuji’s newest series of readers, FCR 5000, includes dedicated algorithms designed to enhance breast images.
• Fuji also displayed a work-in-progress CAD workstation in its booth. The Windows NT-based workstation is being developed by Fuji’s Japanese parent, and Fuji displayed images of Mammography Quality Standards Act-compatible phantoms.

GE Medical Systems

• GE displayed its work-in-progress digital mammography system, Senographe 2000D, which uses flat-panel amorphous silicon detectors. The company also showcased its digital spot mammography device, SenoVision.
• GE highlighted Los Altos Hills, CA-based R2 Technology’s ImageChecker CAD, which GE will bundle with Senographe 2000D once the full-field unit is cleared by the FDA (SCAN 4/29/98).

Imaging Diagnostic Systems

• IDSI highlighted the latest incarnation of its CT laser mammography (CTLM) system, a work-in-progress unit that uses infrared laser light to image breast tissue. The company presented its first collection of in vivo images from the unit, displayed alongside corresponding images taken from other modalities. The Plantation, FL, company has refined CTLM’s scanning table, as well as its laser and reconstruction algorithms. IDSI has begun submitting data to the FDA as its clinical trials progress.

Instrumentarium Imaging

• Instrumentarium displayed its Delta16 TACT (tuned-aperture computed tomography), a digital spot and stereotactic biopsy system, which collects breast images from different angles and converts them into slices for a 3-D image. The Milwaukee-based firm also presented the work-in-progress Delta DX, a full-field digital mammography system that uses flat panels.
• At the show, Instrumentarium announced a $2 million deal with the city of St. Petersburg, Russia, for 40 of its Alpha ST film-based mammography units. The company expects to install the units over the next few months, according to Dmitri Makovkin, Instrumentarium’s area manager in Moscow.

Planmed

• Finnish mammography firm Planmed displayed a prototype of its MaxView Positioning System, which the company is developing for both screen-film and digital mammography. Planmed has an exclusive licensing agreement for the technology with Massachusetts General Hospital and claims that MaxView can image a 10% to 15% larger area than other systems. Planmed hopes to apply for clearance for the unit by the 1999 RSNA show.
• Planmed showed two FDA-cleared upgrades to its Sophie breast imaging and biopsy product line. The company has developed a high-speed, high-output x-ray tube and a bi-phasic paddle, called Twincomp, that compresses tissue toward the chest wall, maximizing the tissue captured on film.
• The company is continuing work on a full-field digital mammography system, researching both CCD-based and flat-panel amorphous silicon technology.

PrimeX General Imaging

• PrimeX General featured images demonstrating that its silicon diode digital imaging array can achieve a spatial resolution of 18 lp/mm, good enough to depict all the objects embedded in the MQSA program’s phantom, according to John Cox, vice president of R&D. Unlike other digital imaging approaches, the investigational technology forgoes scintillation: Collimated x-rays are channeled directly into the silicon diode detector, where photons are converted into electrical energy for processing and readout.
• A clinical trial testing the PrimeX detector commenced in November at the University of California, San Diego, and the University of Arizona in Tucson.
• PrimeX has a nonexclusive agreement with Fischer Imaging, funded by a U.S. Army grant, to develop the technology. It is looking for additional collaborators, Cox said.

Qualia Computing

• Qualia displayed a commercial prototype of its Second Look CAD workstation in its RSNA booth. The Beavercreek, OH, company has begun clinical trials with the unit and expects to meet with the FDA in January to discuss submission of a premarket approval (PMA) application. Qualia is seeking a partnership with an OEM for its CAD technology, according to vice president Philip Amburn.
• Qualia also introduced a prototype of what it calls a network-based, region-of-concern server that it is developing to integrate with digital mammography systems. The server will receive DICOM messages from the systems, mark the digitized image, and send it back to the digital unit.

R2 Technology

• The only CAD developer with FDA clearance for its system, R2 showcased its ImageChecker CAD workstation in its RSNA booth. ImageChecker uses pattern recognition algorithms to identify possible breast abnormalities, as well as neural networks to distinguish real lesions from normal tissue.
• R2 signed an exclusive agreement with GE in April, under which GE will distribute ImageChecker for use with GE’s full-field digital mammography system, pending its FDA clearance (SCAN 4/29/98).

Scanis

• Scanis of Foster City, CA, displayed its Mammex TR CAD workstation as a work-in-progress. Developed in conjunction with TRW Center for Medical Imaging Analysis, Mammex TR uses a rule-based algorithm system rather than neural networks. Scanis will begin preclinical trials in early 1999 and plans to apply for FDA clearance next spring. The company expects to offer Mammex TR in Europe in the first half of this year.
• Scanis also emphasized its recent alliance with Trex. The two firms signed a letter of intent in November in which Scanis named Trex as its exclusive worldwide sales and marketing partner for Mammex over the next five years (SCAN 11/25/98).

Siemens Medical Systems

• Siemens’ mammography special products division displayed its Opdima digital spot option, cleared by the FDA in July 1997, and emphasized Opdima’s DICOM capability. Siemens also highlighted Opdima’s connectivity capability to Biopsys’ Mammotome biopsy driver. Siemens and Biopsys are working on an agreement under which Siemens would sell Mammotome with Opdima, according to Maria Di Palermo, product manager for the company’s mammography division.
• The vendor highlighted its work-in-progress Mammomat 3000 full-field digital system and workstation, particularly the unit’s receptor, which Siemens has been developing in conjunction with Philips and Thompson in the Trixell joint venture. The company expects to begin clinical trials of Mammomat 3000 in 1999, according to Di Palermo.
• Siemens also announced an agreement signed just before the show with TransScan Research and Development, in which Siemens will sell TransScan’s T-Scan 2000 hand-held breast cancer detection device in most global markets, with the exception of the U.S., since T-Scan 2000 has not been cleared by the FDA.

Summit Medical Technologies/Giotto

• The Arlington Heights, OH, company displayed its Summit MT mammography unit, an upright system with a tilted gantry that Summit believes captures two additional centimeters of tissue on images. Summit also highlighted a prone biopsy table that can be purchased separately and used with Summit MT for stereotactic applications.

TransScan Research and Development

• TransScan of Migdal Ha’Emek, Israel, displayed T-Scan 2000, its TransSpectral Impedance Scanning device, an adjunct to conventional mammography that uses a hand-held device to transmit low-voltage electrical signals into body tissue, measuring the changes in the signal to give information about the tissue’s quality. Clearance for the device is still pending.
• The company announced that it has signed an exclusive OEM agreement with Siemens Medical Systems in which Siemens will sell T-Scan 2000 worldwide, with the exception of Korea, Italy, and Israel, where TransScan will market directly.
• TransScan also presented T-Scan 3000, a next-generation scanner that measures electrical impedance using plates similar to those used in mammography, and therefore produces images comparable to mammography images. The company plans to establish an alpha site for T-Scan 3000 in 1999.

Trex Medical

• Highlighted in the Trex mammography booth was a complete digital mammography suite, which included the company’s full-field digital mammography unit, Trex Digital Mammography System (TDMS). The regulatory status of the system was thrown into confusion in December when the FDA denied approval. The Danbury, CT, firm also presented TouchVision, a work-in-progress technology: When physicians touch regions of concern on films mounted on a light box, the adjoining monitor displays the specific area touched.
• Trex’s Bennett X-Ray division displayed two new mammography products, Contour 2000 and Profile 2000, as well as StereoView and Digital StereoView, stereotactic units compatible with sampling devices such as Biopsys’ Mammotome.
• The company also emphasized its recent alliance with Scanis of Foster City, CA (SCAN 11/25/98).

U.S. Surgical

• This Norwalk, CT-based company highlighted its ABBI System Stereotactic Table, as well as MIBB (minimally invasive breast biopsy), a device that uses vacuum-suction to extract tissue. MIBB was cleared in December 1997 and can be used with the company’s Sonopsy ultrasound system or x-ray-based biopsy systems.