Featured infographic: 9 steps to better access—and happier patients. Download.

The Reading Room

Hologic's 3D Digital Breast Tomosynthesis Receives FDA Approval

It's been 5 long years since we first learned of and reported on Digital Breast Tomosynthesis - an exciting new breast imaging technology that could revolutionize mammography. And now, the time has finally come for the much-awaited, highly controversial technology. Just hours ago, the FDA approved Hologic's Selenia Dimensions digital mammography system for 3D breast tomosynthesis, becoming the first vendor to offer the 3D mammography technique in the United States.

 

To date, all mammography images are captured in 2D mode, relying upon a select number of views to assess tissue structure in the breast. While serving as the gold standard for breast cancer screening and diagnosis, 2D mammography (either film or digital) is challenged by the superimposition of images, which can mask suspicious areas, and thus, requires follow-up by other imaging modalities or biopsy. With 3D breast tomosynthesis, a series of thin-resolution images are acquired and aggregated to generate a 3D image of the breast, further allowing the radiologist to scroll through sub-millimeter cross-sections, effectively eliminating the image superimposition. With 3D tomosynthesis, studies have indicated improved tissue characterization, improved tumor visualization, higher diagnostic performance, and a lower recall rate for additional testing. Accordingly, the adoption of 3D digital breast tomosynthesis has significant patient care implications, and potentially, can reduce unnecessary downstream resource utilization.

However, 3D tomosynthesis is not the penultimate breast imaging technique, as their are some significant clinical, operational, and financial considerations associated with the technology, highighted by limited understanding of the technology's role in screening and/or diagnosis, image interpretation concerns, and perhaps most importantly in today's climate, a lack of incremental reimbursement for a technology only now available on Hologic's top-of-the-line Dimensions digital mammography system.

The road to approval has been a long and winding one for Hologic. After years of collecting data, submiting for pre-market approval (PMA), re-filing the application again after the need for more data, and generally navigating a complex regulatory environment at the FDA, 3D tomosynthesis is finally here (and available). In September 2010, the ball started rolling quickly in favor of the technology following a unanimous FDA panel decision to continue the approval process, and then picked up even greater speed with Hologic receiving an "approve-able" letter just prior to RSNA, and having just had a manufacturing site inspection in January.

The implications of tomoysnthesis now being available are sweeping, as this represents a cutting-edge modality capable of re-defining clinical practice for screening and diagnostic mammography. Imaging providers must now adapt different interpretation standards, and need to carefully assess the clinical, operational, market, and financial impact associated with tomosynthesis adoption. Is it necessary for everyone? Do digital mammography systems need to be replaced? What is the investment and deployment strategy?

As perhaps one of the most disruptive technology innovations to occur in recent years, our Technology Insights membership is available to help institutions understand the implications of digital breast tomosynthesis investment. To that end, they will be hosting a webinar in the coming weeks for Technology Insights members to provide perspective on tomosynthesis and investment considerations.

For additional information on tomosynthesis and it's impact on breast imaging programs or the Technology Insights membership in general, please contact Brian Maher, Technology Insights' diagnostic imaging research manager, at maherb@advisory.com.