June 2 , 2008

Teaming Up for Success — First CAD Approved for CR Mammography
By Dan Harvey
Radiology Today
Vol. 9 No. 11 P. 26

In the growing U.S. market for CR mammography, Fujifilm enjoys an enviable position. In 2006, FUJIFILM Medical Systems USA, Inc. became the first vendor to receive FDA approval to sell a CR mammography product—its FCRm system—in the United States.

This April, the FDA gave its nod to sales of FCRm combined with computer-aided detection (CAD) technology, iCAD’s SecondLook. Now, the company has the only CR mammography solution available stateside, and it’s also the only vendor that can offer a CAD/CR mammography coupling to U.S. customers. Studies have shown CAD can improve a radiologist’s ability to detect potentially malignant cancers that may otherwise have been missed and at an earlier stage.

CR Pioneer
Fujifilm is a pioneer in CR technology. It introduced its first CR mammography product to the U.S. market in 1983. Then, in the 1990s, the FDA reclassified digital mammography as a class 3 device—a development that had far-reaching implications for Fujifilm and other vendors.

“At the time, we elected not to seek the necessary reapproval with current technology, as we were developing innovations that would require premarket approval [PMA] from the FDA,” recalls Andy Vandergrift, Fujifilm’s national marketing manager for women’s healthcare imaging.

During the same period, other vendors began focusing on flat-panel DR as a more effective alternative, and CR mammography went dormant for a spell. Subsequently, Fujifilm developed its ClearView-CS for general radiography and the ClearView-CSm upgrade for mammography. Because of the FDA classification change, ClearView-CSm still could not be sold in the United States. But in the early part of the 21st century, it became the most widely adopted digital mammography technology worldwide.

Fujifilm anticipated rapid adoption of the technology once it was FDA approved and developed its FCRm in the form of a multiplate reader to accommodate four cassettes. Prior to regulatory approval, the technology played a large role in the Digital Mammographic Imaging Screening Trial, where it handled about one third of the study’s images, receiving FDA approval in July 2006.

Approval provided imaging centers with different equipment configurations, including the centrally located multiplate reader that serves several rooms or a single-plate reader that’s installed in the exam room. In addition, facilities wouldn’t need to replace existing mammography equipment when transitioning to digital, and one unit could convert as many as three screening rooms at about one half the cost of other DR full-field digital mammography (FFDM) systems. Also, FCRm can be used with general radiology equipment.

Adding CAD
SecondLook, developed by Nashua, N.H.-based iCAD, Inc., features algorithms that incorporate information from thousands of mammography images. Research has shown that its algorithms can detect up to 72% of actionable missed cancers at an average of 15 months earlier than screening mammography alone, according to the company.

Specifically, SecondLook identifies potential cancers with patented artificial intelligence, image processing, and pattern recognition technology. “Those are the three pillars of our core competencies,” says iCAD President and CEO Kenneth M. Ferry. “Upon acquisition, our technology takes the preprocessed digital images from the FCRm system and analyzes the images via those three technical dimensions.”

“SecondLook coupled with FCRm functions very similarly to the way that it functions with the other FFDM vendor products,” Vandergrift says. “Our acquisition console—the IIPm technologist console—sends a for-processing image to the SecondLook server. Algorithms are applied to the image at that server. Then the DICOM structured report is sent to the PACS or mammography workstation and made available to the radiologist to view along with that image.”

SecondLook’s analysis identifies and marks suspicious areas, including masses and microcalcifications, without obscuring the underlying image. “Thus, it marks the suspicious areas on the mammogram for further review,” says Ferry. “Ultimately, we provide a detection device, not a diagnostic device. Our role is to help radiologists find more cancers earlier but not to diagnose cancers. That’s a radiologist’s call. But by marking the suspicious areas, we compel radiologists to take a second look.”

Validated by Study
Ferry adds that the combination of image processing, artificial intelligence, and pattern recognition maximizes sensitivity and minimizes false positives. A 2007 study underscored how well CAD technology combined with CR mammography works. Conducted at The George Washington University (GWU) Medical Center in Washington, D.C., the study involved FCRm and SecondLook technology. “We wanted to investigate the performance of CAD and CR in detecting breast cancer,” says lead researcher Rachel F. Brem, MD, director of the university’s Breast Imaging & Intervention Center, who worked with GWU colleagues and iCAD representatives.

Specifically, the research team wanted to evaluate the CAD/CR coupling in detecting breast cancer based on breast density, mammographic appearance, histopathology, and lesion size. The researchers reported that CAD had a high sensitivity (89%) with CR mammography. And even with conditions that could lower the sensitivity of mammography, the high level was sustained—85% sensitivity with dense breasts and 83% sensitivity for the smallest lesions (1 centimeter or less). Of the 53 breast cancer cases examined, CAD detected 47 (30 cancers in nondense breasts and 17 in dense breasts). In addition, results show that CAD detected 11 of 12 cancers manifesting as calcifications and 36 of 41 masses. “Therefore, the use of CAD with CR mammography will be effective in assisting radiologists with the detection of breast cancer,” the researchers conclude.

The study shows that CAD’s performance with CR is comparable to film screen mammography, Brem adds. Moreover, it will help radiologists spot overlooked cancers, find cancer earlier, and improve patient care.

“What’s extremely exciting about the April 2008 FDA approval is that it now makes CAD a viable solution for CR,” Brem says. “There has been a great deal of interest in CR for mammography already, and now for anyone that wasn’t ready to jump in with both feet, CAD capability is available. Until now, there had been no CAD solution for CR in the United States. So the new availability is a big breakthrough, as it provides a cost-effective and powerful tool that will improve diagnosis of breast cancer.”

Rigorous Approval Environment
Other vendors are preparing to enter the U.S. CR mammography market, having applied for FDA approval of their products. But they are faced with what Ferry refers to as a “very challenging FDA environment” due to a rigorous PMA process that is lengthy and expensive.

“They haven’t been able to gain approval yet,” Ferry says. “For instance, I believe that Carestream Health put in the final PMA module for their CR system back in 2006, and they’re still awaiting approval. When that happens, they should become Fujifilm’s main competitor. But once they get their approval, they will then have to make another application for CAD.”

In addition to Carestream Health, the big market players will be Agfa Healthcare, Konica Minolta Medical Imaging, USA, Inc. and Philips Medical Systems. It is hoped that when the FDA again reclassifies digital mammography (class 3 to class 2), the approval process will speed up a bit. But, at this point, it’s still hard to say when other CR mammography systems will become available. Nevertheless, the companies are poised to compete.

At the most recent RSNA meeting, Carestream Health highlighted its Kodak DirectView CR mammography feature that adds mammography applications and CAD functions to its CR platforms. Agfa will eventually be able to offer its multicassette CR 85-X and single-plate CR 35-X, designed for mammography and general radiography. Konica Minolta Medical Imaging’s REGIUS PureView Mammography System, a CR mammography unit, has been sold in Japan, Mexico, and Europe and awaits FDA approval. Philips will enter the U.S. marketplace with its CR-based PCR Eleva digital mammography system, which has already been sold in Europe for more than 10 years.

Ferry and Vandergrift both understand how arduous the approval process can be. “We had been working with Fujifilm since well before their July 2006 FDA approval for its FCRm, so we saw how long that took,” recalls Ferry. “Within days of that approval, we submitted our PMA supplement, and it took more than 21 months to get the approval for SecondLook combined with FCRm.”

Fujifilm has been installing FCRm systems in the United States for more than 11/2 years. “Within 18 months after our approval, we reached the 500-sale milestone,” reports Vandergrift. “That was without CAD. Now, with the SecondLook addition, we anticipate our sales will accelerate.”

Ferry reports that both companies prepared for a fast market rollout in the United States. “We’ve witnessed steadily increasing interest in CAD from existing and new Fujifilm customers. As they have 500 FCRms installed, it was easy to immediately identify nearly 100 customers who were eager to add CAD technology to this digital platform,” he says.

And it didn’t take long for iCAD to get started. The company installed its first systems about one week after the FDA approval for SecondLook/FCRm sales.

“We now have a two-pronged approach to sales: We’re servicing the existing user base for CR mammography while moving ahead with places that had postponed the purchase of FCRm until the CAD approval,” says Vandergrift.

Ferry describes the arrangement as a collaborative sale. “Essentially, we are ‘OEM-ing’ our product to Fujifilm, who sells it to the customer and then contracts back to iCAD to do the installation and training,” he explains.

Ferry sees CR mammography in general as being attractive to any breast imaging facility that would face financial challenges in transitioning to more expensive digital mammography technology. CR mammography can provide such sites with a practical solution.

There is also competition from numerous direct digital radiography systems for mammography manufacturers that have already been FDA approved. Some in the breast imaging community believe digital direct systems provide superior images; others believe there is no significant difference.

“CR mammography has greater value and versatility than other FFDM platforms, as the technology can be used for both mammography and nonmammography imaging. Currently, there are about 9,000 sites in the United States certified to do mammographic screening. The cost point and cost of ownership of CR mammography, as it relates to service, will enable Fujfilm to capture a great deal of business in the market,” says Ferry.

— Dan Harvey is a freelance writer based in Wilmington, Del., and a frequent contributor to Radiology Today.