(left to right) CTI Breast Cancer System 2100; R2 Technology Checkmate review monitor; Fischer SenoScan

Arguably, there has never been another time when so much emphasis has been focused on women’s healthcare. For some time, digital mammography has been poised to take off, but it was not until November did the FDA give its clearance to soft-copy reading from digital images.

With its approval of GE Medical Systems’ Senographe 2000D for soft-copy reads, potential vendors and market observers say the FDA and GEMS have cleared the way for digital mammography to become a viable product in the medical imaging industry.

One of the next milestones for mammography equipment makers to keep watch for is the next round of Mammography Quality Standards Act (MQSA) regulations, which take affect in 2002.

Regulatory clearance of soft-copy reads is expected to have a significant effect on computer-aided detection (CAD) equipment, which provides a level of diagnostic assurance in the detection of early-stage breast cancer.

R2 Technology Inc. (Los Altos, Calif.) developed the first FDA-cleared CAD system (in 1998) that provides computerized image analysis of digital mammography images.

At RSNA 2000, R2 Technology featured the launch of its 2.2 version of ImageChecker. The processing system converts mammographic films to digital images to permit analysis using algorithms that detect and mark suspicious areas for further review. The processor unit is available as a single loader that digitizes and analyzes one examination at a time. The continuous loader model is capable of delay-free loading 80 films at a time, each marked with an individual bar code to avoid identification errors.

R2 Technology also rolled out its new CheckMate review monitor with touch screen interface. A flat-panel design, this monitor can be wall-mounted near a lightbox or placed on a desktop or near any existing motorized viewer.

R2 also unveiled its LungCheck as a works-in-progress CAD for the early detection of lung nodules using a low dose CT scan. The system is poised to begin FDA trials. R2 also has in development CR or DR lung CAD systems for the early detection of lung nodules.

Scanis Inc. (Foster City, Calif.) introduced its latest version of the Mammex TR for evaluation of mammography. Currently distributed in Europe and Canada, the system is considered an investigational device in the United States.

In a pre-clinical evaluation at the Norris Comprehensive Cancer Center at the University of Southern California, the system was used in a true screening environment. Chapman said that the system did not increase the patient recall rate and reduced the reading time of the least-skilled physician (a post doctoral fellow) in the department.

CadX Medical Systems (Laval, Quebec, Canada) offered the Second Look CAD breast system. Currently installed at 16 sites in Europe, clinical trials are currently underway in the United States. CadX anticipates submitting its application for clearance to the FDA early in 2001.

Using technology that was developed in the fields of image processing and artificial intelligence, Second Look uses proprietary algorithms to identify suspicious microcalcifications and masses from a mammogram.

TransScan Medical Inc. (Ramsey, N.J.) offers impedance imaging as an adjunct to traditional mammography with its patented T-Scan 2000 breast imaging system. The latest version includes improvements in software.

“All software is upgradeable,” said Hal Kirshner, chairman, president and CEO of TransScan. “None of these systems will become obsolete. Free upgrades are available for the next five years.”

The system is used to evaluate ambiguous mammography results when a physician is deciding whether to biopsy a suspicious lesion. Research suggests that T-Scan, when used in an adjunct capacity, has the potential to substantially reduce negative biopsies while increasing the net number of cancers detected.

Approved as a non-invasive adjunctive diagnostic tool in April 1999, the system has been FDA-approved only as an adjunct to traditional mammography.

The Diamond breast care system by Instrumentarium Imaging Inc. (Milwaukee) was showcased at RSNA. The Delta 32 is the digital camera at the heart of the system, and TACT is a 510(k)-cleared digital software option that reconstructs a 3D image from a 2D image taken with the digital receptor.

ECS (easy compression system) is another exclusive feature of the Diamond. As a nonconventional method of field preparation, bi-directional compression of breast tissue is more comfortable for the patient and includes more breast tissue in the imaged area.

Introduced as a works-in-progress, TACT 3D images renderings from C-arms is under development. Using the same algorithms as the breast imaging system, the company will be entering FDA trials in the future.

Hologic Inc. (Bedford, Mass.) comes to RSNA having transformed itself from a bone densitometry company to a much broader radiology solutions company.

In mammography, Hologic has made the decision to discontinue the former Trex Medical Corp. (Danbury, Conn.) Bennett line and keep the Lorad products.

At RSNA, Hologic was most proud of its new works-in-progress 25 cm-by-29 cm digital detector for full-field digital mammography. The detector features selenium coating on a thin-film transistor matrix for enhanced image quality and dose efficiency. Hologic hopes to have the detector ready for the market by the end of 2001, if all regulatory approvals are received.

If and when it is FDA-cleared, Hologic plans to use the selenium detector to upgrade its Lorad M-IV mammography system to an M-IV Platinum model.

Hologic also introduced the Lorad M-650 mammography system, which the company will position in the mid-$60,000 range, just below the Lorad M-IV. The M-650 will be available in international markets initially; plans are to have it in the U.S. market by September.

Following a major company reorganization, Fischer Imaging Corp. (Denver) launched its SenoScan.

The SenoScan full-field digital mammography system is designed for breast cancer screening and diagnostic procedures. Using Fischer’s slot scanning technology, which scans a thin X-ray beam across the breast concurrent with an array of CCD sensors below, the system can provide an image resolution of 50 microns. The system is designed to reduce radiation dose to the patient, while improving the resolution of the images for both screening and diagnostic purposes. Used in its ultra-high resolution mode, the system can produce images with pixels as small as 25 microns.

Fischer has completed an FDA reader study for SenoScan. The data currently is under analysis, with submission anticipated soon. Just prior to RSNA, Fischer Imaging and CADx announced an agreement to integrate the CADx Second Look software into Fischer’s SenoScan system.

GE Medical Systems’ Senographe 2000D is still the only FDA-cleared full-field digital mammography system.

“There are more than 100 systems installed globally, with more than 50 in the U.S.,” said Samantha Allison, general manager, women’s healthcare business. “We expect to have 70 installed by the end of [2000].”

GEMS also reports a developing works-in-progress in partnership with R2 Technologies to incorporate CAD into GEMS’ digital mammography system. Allison added that GEMS plans to file for FDA approval in early 2001.

Tomosynthesis 3D is another GEMS’ works-in-progress. Working in collaboration with Massachusetts General Hospital (MGH of Boston), the system uses 11 exposures of breast tissue to produce planar views to aid diagnosis.

GEMS also highlighted a partnership with Pronosco (Vedbaek, Denmark) to add bone density screening capabilities to the GEMS traditional film-screen mammography system. The X-posure system from Pronosco currently is available in general radiography rooms, takes an X-ray image of the hand, digitizes it, and uses algorithms to assess bone mineral density as an osteoporosis screen.

GEMS hopes to have FDA clearance for the combined product in early 2001.

Computerized Thermal Imaging (CTI of Layton, Utah) is seeking premarket approval (PMA) from the FDA for its Breast Cancer System 2100, a noninvasive, radiation-free unit that provides a physiological view of the breast without compressing the breast.

CTI’s Breast Cancer System 2100 consists of three elements: a heat-sensitive digital camera that acquires the data, computer software that analyzes the data, and the clinical evaluation of the data.

Lynn Satterthwaite, CTI vice president of engineering, said the price for the procedure is expected to be competitive with traditional mammography at a range of $100 to $300 per patient.

iMammogram.com (Westlake Village, Calif.), meanwhile, offers its “CloserLook” service, which provides women and their doctors with a computer-aided detection (CAD) analysis of their mammograms.

CloserLook from iMammogram.com uses FDA-approved CAD technology for mammograms — the ImageChecker from R2Technology — to detect early signs of cancer on screening mammograms.

Eastman Kodak Co.’s (Rochester, N.Y.) Health Imaging division debuted a new premium X-Sight medical imaging system for general radiography. The new X-Sight G/RA film is both high-resolution and high-contrast for applications which require fine details. The new Kodak X-Omat Multiloader 7000 offers high-capacity daylight loading in a system about half the size of the X-Omat Multiloader 700 and has a lower price point.