Improved diagnostic accuracy: FUJIFILM’s DBT software upgrade receives FDA approval

Holland, 1931. Bernard George Ziedses des Plantes worked hard on the world’s first tomosynthesis machine, publishing a paper on the device he called a Planigraph. His clinical results were presented at the 1931 meeting of the Netherlands Society of Electrology and Radiology in Amsterdam, and the first commercial device was produced just a few years later.

Fast forward to 2017, and tomosynthesis is on the cusp of another large-scale adoption: breast screening. Digital breast tomosynthesis (DBT) can reduce the number of women recalled for follow-ups after breast screening, producing a net cost savings for care providers. In a world where reimbursement is increasingly tied to performance, higher-quality imaging is the way of the future.  

Earlier this year, FUJIFILM Medical Systems U.S.A. Inc., announced that it had received FDA approval for the DBT software upgrade for its ASPIRE Cristalle mammography unit. Two Fujifilm executives—Johann Fernando, PhD, chief operating officer, and Eiji Ogawa, vice president of modality solutions —spoke with Health Imaging to discuss that approval and what it means for the company’s future.

How does it feel to have this FDA approval and move forward with this DBT software upgrade?

Fernando: We are very excited about the opportunity we have with this FDA approval. We’ve been working very diligently across the board and our teams have been working closely to develop the DBT upgrade. Now that we have the approval, we are working to get it out the door and into the hands of customers.

The upgrade is available as a software update, so we’re collaborating with clinical partners who have our ASPIRE Cristalle software to provide an upgrade path, allowing them to take advantage of the digital breast tomosynthesis (DBT) capabilities. We’re also finding ways to expand our install base in all market segments, from small community hospitals to large academic centers.

Why is it so important for modern mammography solutions to include DBT capabilities? 

Ogawa: There is ample research that shows DBT, when used in addition to mammography, increases diagnostic accuracy, including in women with dense breast tissue. For healthcare providers, there are many benefits derived from using DBT such as increasing cancer detection and reducing unnecessary callback rates. DBT can be used for both screening and diagnostic purposes. As one of the latest advancements in breast cancer technology, DBT is in demand not only at facilities but also with women—healthcare consumers.

This upgrade has been available in Europe, Asia and Latin America since 2013. What has the reaction been from patients and providers in those areas since it was first made available?

Fernando: The reaction has been very positive. For example, in Japan—where this software has been available for almost a year now—we have more than a 50-percent market share. The feedback we’ve been receiving from our partners in Europe has been similarly positive, especially because of the hexagonal close pattern (HCP) detector, which optimizes patient dose while improving image quality.

How does this DBT software upgrade and improve the level of care patients can receive from Fujifilm’s ASPIRE Cristalle digital mammography system?

Ogawa: Better diagnostic accuracy will be achieved when DBT is used with traditional 2D mammography. Fujifilm’s ASPIRE Cristalle combines innovative HCP image capture technology and intelligent image processing, which result in brilliant image quality with low dose.  In fact, HCP technology increases detector sensitivity by 20 percent compared to traditional square pixels. The DBT software upgrade maximizes image quality by enhancing the visualization of suspicious features masked by overlapping tissue to increase diagnostic confidence.

Let’s look ahead for just a moment—what is next for Fujifilm’s ASPIRE Cristalle digital mammography system?

Fernando: We are continuing to make improvements on the Cristalle platform, working from both our offices in the U.S. and our offices in Tokyo. We continue to improve the image quality, provide the lowest dose possible and streamline workflow.

For example, we have our Synapse Workstation platform, which can import and visualize large DBT data sets. When a radiologist is making a decision on a patient they might bring together several data sets; PET, nuclear medicine, or mammography information. A radiologist would view these images together to get a better idea of the location of the lesion in the patient’s breast. However, the denser the breast, the harder it is to detect these lesions.

Synapse Workstation allows physicians to combine this data into one database and display the images together. Hospitals without Synapse Workstation often need a dedicated workstation to process and view DBT data sets, decreasing productivity. So, we are offering that as a part of the package, bundling Synapse Workstation to customers who have an earlier version of the software in addition to new customers who’d like to migrate to a Synapse workstation.

Fujifilm will have the ASPIRE Cristalle system with the DBT upgrade on display at a variety of conferences this year. What should attendees be on the look for if they have the opportunity to see it in action?

Ogawa: Visitors to the Fujifilm booth at industry conferences can expect to see brilliant image quality and excellent dose efficiency from our high sensitivity detector and intelligent image processing technologies. In addition, they should ask about the fast and easy workflow features that are built into the sophisticated system design of ASPIRE Cristalle. Finally, Fujifilm is also very focused on patient comfort. For example, our patented, flexible comfort paddle provides gentle, even compression of the breast, ensuring that a mammography exam is as comfortable for a woman as possible.