From my colleague and imaging technology expert Brian Maher - we'll be tracking this closely but wanted to share this with you immediately:
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 email@example.com.
"Typical" Volumes for a Breast Surgeon
Several years ago, women's health vendor Hologic introduced the concept of 3D digital breast tomosynthesis, a new technology thought to revolutionize the breast imaging specialty by increasing the performance of standard 2D digital mammography. Interest from the health care community immediately sparked, with many experts indicating breast tomosynthesis could ultimately supplant digital mammography as the modality of choice for the screening and diagnosis breast cancer in any setting. Despite its promise, the years came and went, but still no tomosynthesis product. The lack of clinical data, a very complicated FDA reviewal process, unclear indications for use, and myriad other factors were, and still are, to blame. Now, it appears one very important and cumbersome barrier to tomosynethsis development is beginning to budge.
Last Friday, the FDA's Medical Devices Advisory Committee - a group consisting of clinicians, statisticians, patient advocates, and industry representatives - convened to advise the FDA on whether or not to proceed with approval for Hologic's Selenia Dimensions 3D tomosynthesis system. In a 12-0 vote, the panel overwhelmingly, and somewhat surprisingly, came out in favor of the FDA approving the device and moving forward in the pre-market approval (PMA) process. While many radiologists, technologists, administrators, and members of industry anxiously await the final decions from the FDA, last week's panel recommendation to proceed in the formal FDA review process marks a historic first step towards a definitive answer.
More Detail on Recent FDA Recommendation for Breast Tomosynthesis
Recently we ran a piece in the Daily Briefing summarizing a piece written by the NY Times discussing whether or not robotic surgery actually saves hospitals money in the long run by reducing complications etc. Then my colleague Matt Garabrant wrote a comprehensive response to the article. I've reproduced both for you below as I know it's a controversial topic.
Daily Briefing article summarizing NY Times feature citing cost reductions
By reducing length of stay (LOS) and complications, robotic surgery can help hospitals reduce overall treatment costs and produce a net savings of $1,200 per surgery, an expert contends in the New York Times.
Seeking to explain the growth of robotic surgery, Catherine Mohr--a professor of surgery at Stanford University School of Medicine and director of medical research at Intuitive Surgical, which created the da Vinci Surgical System--argues that the economics of minimally invasive surgery (MIS) are "simple": robotic surgeries save hospitals money.
Mohr writes when MIS was first introduced in 2000, only about 1,000 robotic surgeries were performed worldwide and the cost for each procedure--including technology, training, supplies etc.--was largely prohibitive, totaling nearly $11,500 per surgery. However, by 2009, researchers had established the "superior outcomes" of MIS--including shorter LOS, less post-operative pain and accelerated recoveries--and more than 200,000 robotic surgeries were performed that year. For prostatectomies in particular, robot-assisted procedures grew at an "unprecedented" rate, accounting for 75% of all prostate surgeries performed in 2009 (see related coverage in the Feb. 17 Daily Briefing)(Mohr, "Freakonomics," Times, 7/20).
Does robotic surgery save hospitals money?