RSNA show abuzz with talk of digital mammography clearance

Digital mammography developers received a surprise at the RSNA show this year when GE announced that it had filed a premarket approval application (PMA) in October for its unit, Senographe 2000D. The news changed the digital mammography landscape dramatically.

On Dec. 16, the FDA’s Medical Devices Advisory Committee held a public meeting to discuss GE’s application, and recommended that the unit be cleared for hard-copy diagnostic and screening mammography. If the FDA does take the panel’s suggestion, Senographe could be on the market by the first quarter of this year. Digital mammography developers are now faced with the decision whether to switch to a PMA process or continue on the 510(k) path. Although tired of digital mammography’s long and arduous trek toward regulatory approval—and surprised by GE’s quick application—vendors emphasized continued commitment to the technology in their booths.

CAD developers went to the meeting optimistic about their technology’s future. Firms such as R2 Technologies, Qualia Computing (which displayed Second Look in its partner CADx Medical Systems’ booth), and Scanis highlighted upgrades to their units, and emphasized CAD technology’s potential to become even more integrated into the mammography screening process.

Biopsys Medical/Ethicon Endo-Surgery

• This Cincinnati-based Johnson & Johnson subsidiary highlighted its Mammotome biopsy system at the RSNA show, as well as Mammotome Hand Held, a new unit cleared by the FDA in September. The original Mammotome is compatible with other prone and upright units available in the industry. Both units can be used with ultrasound guidance systems. Also displayed in Biopsys’ booth was Neoprobe’s neo2000 gamma detection probe system for lymphatic mapping.

CADx Medical Systems

• In its booth, Quebec-based CADx presented partner Qualia Computing’s Second Look computer-aided detection workstation. The two companies established an alliance in July, in which CADx has worldwide exclusive marketing rights to Second Look and CADx acts as the R&D team for CADx.
• Qualia has Second Look in clinical trials, and expects to finish those trials and submit a PMA for the unit by the end of the first quarter. CADx expects to both apply for the CE Mark and place a production unit in Europe early this year. The company is also developing a digital version of Second Look.

DBA Systems

• DBA Systems of Melbourne, FL, displayed six work-in-progress products in its ImagClear Mammography Review System line of workstations. The company’s offerings now include two image capture units, Tech 1200 and Tech 5000, three capture and viewing systems, CV2000, CV4000, and CV6000, and one viewing-only product, CV5000. The systems can be used with both Windows NT and Apple Macintosh platforms and use ImagClear film scanners with 16-bit output. In April, DBA Systems applied for FDA clearance for CV6000, and will submit applications for the other units once the first has been cleared.

Dilon Technologies

• Making its RSNA debut, Dilon Technologies displayed Dilon 6800, its portable gamma camera for scintimammography. The unit received 510(k) clearance this spring from the FDA as a mammography adjunct device, and is in clinical trials at Johns Hopkins University School of Medicine. Dilon expects to begin shipping the system in the first quarter.
• The camera’s field-of-view is 6 x 8 inches, and its small amount of dead space—10 mm—differentiates it from standard gamma cameras and allows clinicians to image close to the patient’s chest wall, according to the company. Dilon 6800 has detected lesions as small as 3 mm, and can be used with patients in a sitting position. It produces all standard mammographic images, including craniocaudal, lateral, mediolateral, and oblique.
• The Newport News, VA-based firm also highlighted a work-in-progress unit, Dilon Gamma-Guided Biopsy System, which it is developing with Trex Medical.

Dobi Medical Systems

• Another firm has joined the ranks of those developing optical breast imaging units. At its first RSNA show, Dobi Medical Systems showcased its Dynamic Optical Breast Imaging (DOBI) system. The unit measures the transmission of red and near-infrared light through the breast to detect differences in normal and diseased tissue. DOBI’s detector consists of a breast holder with an array of light-emitting diodes and a thin latex cup to slightly compress the tissue, according to the company. A digital camera records the amount of light transmitted through the breast. The Mahwah, NJ, company received the CE Mark for DOBI in May 1998, and plans to submit a PMA application to the FDA in the second quarter of this year.

Fischer Imaging

• At its booth, Fischer showcased Mammotest Plus/S, a surgical version of its stereotactic breast biopsy table Mammotest Plus, as well as MammoSound, a work-in-progress ultrasound-guided gantry that will attach to Mammotest Plus/S. The company also displayed another work-in-progress unit, MammoVision Elite, a digital imaging chain upgrade for Mammotest Plus/S that uses cesium iodide detectors.
• Denver-based Fischer also highlighted its full-field digital mammography system, SenoScan, which is based on CCD and slot-scanning technology. The company displayed panels with phantom images performed at 25 and 50 microns, which it believes are the highest resolution in the industry. Fischer took a wait-and-see approach to its regulatory submission for SenoScan, pending the public meeting Dec. 16 regarding GE’s PMA submission. The company is evaluating the best type of submission, and hopes to apply for clearance by June.
• At the show, Fischer and Qualia began discussing a potential supply deal in which Qualia would provide Fischer with its computer-aided detection unit, Second Look, to be incorporated into SenoScan once it is cleared by the FDA.

Fuji Medical Systems USA

• Fuji presented what it called a mammography continuum in its booth. The Stamford, CT, company emphasized a portfolio of work-in-progress digital mammography products that address acquisition, diagnosis, and image management. The company is working with the FDA on a regulatory approval application for its digital mammography products.
• On display was Fuji’s FCR 5000R-ID CR reader, which includes algorithms that enhance breast images and can process up to 115 plates per hour. FCR 5000R-ID produces both 18 x 24-cm images and 24 x 30-cm images, and can store original exam data digitally. The company also highlighted its digital CAD reading workstation based on Windows NT, which it introduced last year.

GE Medical Systems

• GE showcased its full-field digital mammography system, Senographe 2000D, for which it submitted a premarket approval application to the FDA on Oct. 29 (SCAN 12/15/99). The company was granted an expedited review, and on Dec. 16 the agency’s Radiological Devices Panel of the Medical Devices Advisory Committee recommended that the unit be cleared for hard-copy diagnosis and screening. GE hopes Senographe 2000D will be on the market early this year.
• The firm unveiled a new mammography unit at the show: Senographe DMR+. Launched in July, the unit includes MaxiRay, a bimetal rhodium/molybdenum x-ray tube, and Sharp IQ, a feature that allows Senographe DMR+ to move at the same speed as film to reduce scatter and capture better images. GE also highlighted Senographe 800T and its digital spot and stereotactic system, SenoVision.
• The Waukesha, WI-based company showcased digital processing developments for mammography such as multiresolution processing, which allows for even exposure of areas of different tissue density, and R2 Technology’s ImageChecker computer-aided detection system. GE will sell ImageChecker with Senographe 2000D once both units have been cleared by the FDA.

Imaging Diagnostic Systems

• Imaging Diagnostic Systems (IDSI) of Plantation, FL, highlighted its Computed Tomography Laser Mammography (CTLM) system, which carries an integrated array of 168 detectors and a laser beam that rotates around the breast to create 3-D tomographic images with no compression of breast tissue. IDSI has placed CTLM at two clinical sites: Nassau County Medical Center in East Meadow, NY, and the University of Virginia at Charlottesville. The company plans to meet with the FDA to discuss a PMA this month, and hopes to submit its application to the agency by midyear.
• IDSI has added to CTLM reconstruction algorithms that present image data in traditional craniocaudal and mediolateral views, and showed images from six reconstructed cases on panels in its booth.
• In September, IDSI received a patent from the U.S. Patent Office that allows it to use its scanner with fluorescent compounds under development by contrast agent manufacturers, according to the firm. The compounds are targeted to particular cancer cells, and fluoresce in the presence of enzymes found in those cells, according to IDSI.

Instrumentarium Imaging

• Instrumentarium highlighted its tuned-aperture computed tomography (TACT) software, which allows clinicians to view breast tissue layer by layer in a 3-D image. The firm has continued to gather clinical data for TACT, and expected to submit a 510(k) application to the FDA by the end of 1999. The company emphasized TACT with its Delta 16 digital spot and stereotactic biopsy system.
• Milwaukee, WI-based Instrumentarium has continued its work on Delta DX, a full-field digital mammography system that uses flat-panel detectors. The company has made changes in its detector technology, switching from amorphous silicon to amorphous selenium.
• The company also highlighted its Alpha line of mammography units, which carry Instrumentarium’s optional easy compression system (ECS). ECS takes advantage of the mobility of breast tissue by moving the cassette down onto the breast while simultaneously moving the bucky up.

Planmed

• Finnish mammography firm Planmed displayed its MaxView Positioning System, which it has developed with Massachusetts General Hospital. Maxview can image an additional 2 cm of breast tissue compared to conventional mammography devices, according to Planmed. The company received clearance for Maxview from the FDA in August, and expects to begin shipping it in mid-2000.
• The company showcased a work-in-progress digital spot biopsy device that can be added to its Sophie and Sophie Classic units, and presented Cytoguide, a biopsy needle guidance system.
• At the show, Planmed signed a nonexclusive distribution and marketing agreement with Shimadzu Medical Systems, under which Shimadzu will sell Planmed’s Sophie, Sophie Classic, and Sophie Mobile mammography units.
• Planmed highlighted two upgrades for its Sophie unit: a high-speed, high-output x-ray tube, which the company began shipping last February, and Twincomp, a biphasic paddle that compresses tissue toward the chest wall.
• The company is continuing work on a full-field digital mammography system based on slot-scanning technology. It expects the unit to have resolution of more than 13 line pairs, and hopes to unveil a prototype at this year’s RSNA meeting.

R2 Technology

• Since it is allied with GE, R2 Technology could bring a digital version of its ImageChecker CAD unit to market in the near future. Once GE’s digital mammography unit is cleared, R2 will submit its own application to the FDA for a digital version of ImageChecker, which will be offered as an option for GE’s Senographe 2000D.
• In addition to its partnership with GE, R2 has a distribution agreement with Marubeni America in Japan (SCAN 6/23/99), and has established a sales and service network of 25 dealers across the U.S.
• The Los Altos, CA, company is exploring the potential for CAD technology to be used more fully in the mammography screening process, and displayed panels on such future applications for the technology as prioritizing suspicious cases for technologists, the company said.

Scanis

• Scanis highlighted its Mammex TR CAD workstation, which it has developed with TRW Center for Medical Imaging Analysis. Mammex TR uses a rule-based algorithm rather than neural networks. Scanis planned to apply for the CE Mark for Mammex TR by the end of 1999, and hopes to obtain that certification early this year. Scanis shipped a unit to its first European beta site in Zurich, Switzerland, in November.
• The Foster City, CA, company has improved Mammex TR’s processing time, and has conducted a preclinical study at the University of Southern California’s Norris Comprehensive Cancer Center. Scanis hopes the study will produce data it can use for a PMA application that it expects to submit to the FDA for Mammex TR this spring.

Siemens

• Siemens’ mammography special products division brought two new systems to the RSNA show: Mammomat 3000 Nova and Mammomat 1000. Mammomat 3000 Nova is an upgrade to Mammomat 3000, and has an improved Automatic Exposure Control (AEC) system and modified biopsy paddles. The paddles can be used with Siemens’ Opdima digital spot option. Mammomat 3000 Nova is the company’s platform for its work-in-progress digital unit. Siemens began clinical trials in October at the Medical College of Virginia for its digital system, and will pursue the PMA if that regulatory path is indicated by the FDA, according to the company.
• Mammomat 1000 is based on the same technology as Mammomat 3000 Nova, but without that unit’s pivoting bucky and without digital upgrade capability. The device was designed to be a second unit in high-volume centers or a single unit in smaller practices. Mammomat 1000 can also support Opdima.
• Iselin, NJ-based Siemens has begun marketing TransScan Research and Development’s hand-held breast cancer detection device, TS-2000. TransScan won clearance for a PMA supplement for the unit in November.

Summit Medical Technologies/Giotto

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

TransScan Research and Development

• TransScan highlighted TS-2000, its TransSpectral Impedance Scanning device, a hand-held unit that measures electrical impedance in breast tissue and includes a ground-electrode cylinder that patients hold as it transmits a low-voltage electrical signal through the body. The unit was initially cleared by the FDA in April for use as an adjunct to mammography in follow-up exams for patients with equivocal mammograms (SCAN 4/28/99). In November, TransScan won clearance from the FDA for a PMA supplement that covers improvements in TS-2000’s design and operation. The Ramsey, NJ, firm announced the news along with Siemens Medical Systems, with which it signed a marketing agreement last December (SCAN 1/7/99).
• TransScan emphasized TS-3000, a work-in-progress next-generation scanner that it hopes will be able to capture the entire breast with one image. The company is also planning to develop TS-2000 for other applications, including skin cancer, thyroid, and liver imaging, and to develop lymph node and biopsy probes for the unit.

Trex Medical

• In its booth, Trex highlighted its consolidated mammography product line, which now consists of both Bennett and Lorad products under the Lorad name. The Danbury, CT, firm displayed its M-IV, Contour 2000, Elite, and Profile 2000 units, as well as its stereotactic line, which includes MultiCare dedicated prone biopsy table, StereoLoc II upright unit, and StereoView.
• Trex also stressed its commitment to its Trex Digital Mammography System. The company is working on a PMA application for the unit to submit to the FDA, according to Bill Webb, president and CEO.
• In November, the company signed letters of intent with two firms, Dynamic Imaging of Scotland and Dilon Technologies, in an effort to expand its breast imaging product scope. Dynamic Imaging will help Trex develop an ultrasound system for breast imaging, and Dilon will help the company develop a gamma-guided biopsy unit.

U.S. Surgical

• U.S. Surgical emphasized its ABBI System Stereotactic Table, as well as MIBB II, its next-generation minimally invasive breast biopsy device that uses vacuum suction to extract tissue. Originally cleared in December 1997, MIBB II can be used with the company’s Sonopsy ultrasound system or x-ray-based biopsy systems. The company also introduced MIBB Site Marker, a biopsy site clip that works with most vacuum probes, including MIBB II and Biopsys’ Mammotome.
• The Norwalk, CT-based company highlighted Navigator, its cadmium telluride-based gamma-detection probe for lymphatic mapping. Navigator uses high-energy tungsten shielding.