Pink ribbons and autumn may signify breast cancer awareness, but mammography systems—the devices regularly used to detect such disease—are at the center of the fight against breast cancer. Below, 24×7 Magazine sits down with Robert Fabrizio, director of strategic marketing, Fujifilm Medical Systems U.S.A.; Pam Cumming, director of women’s health, Siemens Healthineers North America; and Barbara Rhoden, marketing director, GE Healthcare Women’s Health U.S and Canada, to discuss what’s new in mammography equipment and what HTM professionals should know about handling these delicate—and potentially lifesaving—devices.

24×7 Magazine: The mammography equipment sector is projected to see strong growth in the next decade. What’s propelling this demand?

Robert Fabrizio: The increase in demand is due to the increase of women getting mammograms. This is in part due to increased awareness through campaigns and public messaging; access to imaging with growth in imaging centers; and, most importantly, an understanding that early detection saves lives. 

Pam Cumming: Several factors are at play here. A significant body of global clinical studies has proven that digital breast tomosynthesis (DBT) detects cancers earlier and reduces unnecessary false positives. The studies support the fact that DBT can improve accuracy and radiologists’ diagnostic confidence. Image processing continues to improve, making it easier to see and either confirm or rule out architectural distortions, which are early indications of disease.  

February saw the passage of a federal law that requires mammography facilities to include breast density information in reports sent to patients and their physicians; that law came after dozens of states adopted similar legislation, spurred by the efforts of advocacy organizations. This sort of advocacy and resulting state and federal legislation further fuels consumer awareness of breast imaging, breast density, and particularly DBT. Increasingly, we’re seeing DBT screening being adopted worldwide. 

Facilities with a mixed full-field digital mammography/DBT environment are looking at standardization, and early adopters of DBT technology are looking at updated systems with a host of features that weren’t available eight to 10 years ago.

Barbara Rhoden: I would point to several contributing factors: First, with an aging population, more and more women need to get mammograms. In fact, according to the American Cancer Society, about two out of three invasive breast cancers are found in women 55 or older. Many recent studies have shown that 3D mammography or DBT finds more cancers—yet the technology is still being adopted, so there’s an increased demand. In addition, there are government-mandated initiatives, such as the, that will likely drive an increase in reimbursement. Overall, we’re seeing innovative technology advancements and increased patient awareness.

24×7: How has the mammography device market evolved in recent years? How do you expect it to evolve even more in the future?

Fabrizio: DBT has helped increase mammographer confidence and the ability to identify cancers earlier than with traditional 2D mammography alone. [Specifically, DBT can] help reveal subtle cancers hidden between layers of breast tissue, long before they can be detected by self-examination.

With the growing adoption of DBT, new software advancements are being introduced to further deliver exceptional imaging while lowering dose. For example, Fujifilm offers S-View with its Aspire Cristalle digital mammography system with DBT. S-View enables radiologists to view a synthesized 2D image reconstructed from DBT, eliminating the need for a separate, dedicated 2D exposure. Moreover, an S-View image can be used together with tomosynthesis views for both screening and diagnosis. And by using S-View images, instead of dedicated 2D, it is possible to reduce dose by up to 50%.

In addition, in the era of personalized care, we are innovating to improve patient comfort. Fujifilm’s patented Comfort Paddle, for instance, allows pressure to be more evenly and gently distributed across the breast compared to conventional, flexible paddles. A noticeably more comfortable exam also helps women comply with annual screening guidelines and recommendations to family members to get their screenings.

Rhoden: There has been a significant increase in the adoption of tomosynthesis, or 3D mammography. We also see value-based care and the overall patient experience having an impact; providers are investing to ensure the overall experience is improved. After all, if they can bring in a woman who has a positive experience, she may also bring her friends, family, and larger network. It becomes a win-win for the patient andprovider.

There’s also an increased focus on personalized breast care. We know that “one size does not fit all” when it comes to breast health. Clinicians and providers are now considering an individual’s risk profile for each patient and offering a multimodality approach so they can catch anything suspicious early.

In the future, I expect we will see a greater increase in nontraditional partnerships focused on personalized breast care. For example, Ob-Gyn offices are becoming more focused on the whole body and are offering mammograms. Many retail healthcare settings, like pharmacies, are evaluating adding mammography screening services. Providers are meeting patients where they are. 

We also can’t talk about the future without highlighting how artificial intelligence (AI) technology will help to elevate breast care. The impact of AI to predict risk, find, diagnose and treat breast cancer is already being seen. One example is highlighted in radiology, where researchers have developed a new tool using deep learning technology to predict a woman’s future risk of breast cancer.

Cumming: New vendors are pushing innovation on many levels and helping to make DBT accessible to sites that only a few years ago would not have considered it. We are seeing lower patient radiation dose with the adoption of synthesized 2D imaging, alongside increased levels of breast cancer detection, with a reduction in the patient callbacks that can dissuade a woman from obtaining future mammograms. We are also seeing more patient-friendly breast imaging systems that personalize breast compression and dose for an improved patient experience. 

In the future, expect artificial intelligence to increase workflow efficiency and system performance. AI/deep learning algorithms may bolster physician productivity and possibly increase cancer detection, in addition to helping ensure consistent performance across all levels of physician. We will see increased levels of automation to help promote standardization and consistency among technologists, in keeping with the goal of the Enhancing Quality Using the Inspection Program initiative introduced by the Division of Mammography Quality Standards. Three-dimensional breast imaging is expected to grow steadily due to higher patient volumes, its time-saving efficiencies, and its reproducibility over handheld ultrasound.

24×7: What are some of the biggest challenges currently affecting the mammography device sector? How is the industry working to overcome them?

Rhoden: A constant challenge is ensuring broad access to high-quality mammography and supplemental screening. There are many organizations and patient advocate groups, such as the Young Survival Coalition and The Balm in Gilead, Inc., that focus on reducing barriers to care for disenfranchised groups. 

There are also challenges that come with the adoption of 3D mammography. Clinics often need to upgrade their IT infrastructure to allow for the flow of data. In addition, it can take more time to review digital breast tomosynthesis studies since radiologists must review many more images.[Fortunately,] artificial intelligence can be used to alleviate these pain points. Deep learning tools that provide reading and decision support aim to not only increase sensitivity and specificity, but improve reading efficiency and the user experience.  

Cumming: DBT must still overcome challenges related to imaging dense-breasted patients and overlapping breast tissue. On a promising note, one study demonstrates that wider-angle acquisition is now possible with some newer DBT systems that provide higher in-plane resolution.  

And while significant progress has been made in recent years with respect to insurance providers covering DBT, some patients still pay a significant out-of-pocket fee for 3D mammography screening. During Breast Cancer Awareness Month and beyond, equipment manufacturers can increase patient awareness regarding DBT’s benefits. 

24×7: What are some of the biggest innovations in mammography equipment right now?

Fabrizio: The industry is continuously innovating the software powering mammography equipment. Specifically, new advancements in mammography software are increasing clinical confidence and efficiency of mammography systems. Features and software that automatically detect breast density—such as AI-powered image processing and computer-aided detection—are just some of the continual advancements happening every day.

Rhoden: There’s an increased interest in applications that allow for a shorter time to diagnosis with increased or similar specificity and sensitivity to the gold standard. Tools like contrast-enhanced spectral mammography (CESM) and abbreviated MR can now offer critical information in less time. A key advantage of a tool like CESM is that the exam can be performed in less than seven minutes—using the same mammography equipment, in the same room, with the same staff. This significantly shortens the time between the initial diagnosis and the treatment plan. This also ties in to the overall focus on the patient experience to ensure that women are compliant with their annual mammograms.

Cumming: Equipment manufacturers are working to advance the image acquisition process to virtually eliminate patient motion, which can cause artifacts. These manufacturers are also integrating artificial intelligence and advanced reconstruction algorithms into their hardware to enhance micro-calcifications, as well as incorporating deep learning algorithms to improve physician workflow and distribute the more difficult patient cases to specialists. CEDM is experiencing widespread acceptance, and we will see further advances in not only tomosynthesis, but also biopsy using CEDM—especially where MRI is not readily available and/or financially accessible.

Additionally, vendors are integrating features and functions into their equipment that were previously available only as options. And information on each patient’s breast density is now available directly on the acquisition workstation of some systems, enabling adjustment of the care pathway to encompass ultrasound or MRI before the patient leaves. This reduces patient anxiety and helps ensure the patient is compliant with diagnostic protocols.  

24×7: What else should imaging equipment specialists—those likely tasked with repairing mammography equipment—know about these devices?

Fabrizio: Factory training and reliability are critical. Another very important element to plan for is the volume of images and the sizes of datasets. Files and data transfer are very different when converting from 2D to 3D—and even one system to another. This needs to be addressed appropriately as part of the conversion planning process.   

Cumming: Application whitelists are lists of applications and components that are authorized to be present or active on a host. Consider investing in advanced IT security with application whitelist capability to control which applications are permitted to be installed or executed on your mammography system; this will help safeguard against the execution of malware and other unauthorized software. Also, mammography systems used in a mobile configuration should possess detectors with robust temperature tolerance so that they continue to function smoothly in extremely hot and cold conditions.

Rhoden: As medical device manufacturers, we offer biomedical engineers support via education and technical training, remote access to tech support, and the GE Healthcare Service Shop. These can all be tailored to the individual OEM support needs that the biomedical team may require.