U.S. Breast Tomosynthesis Market – Is Change on the Horizon?

9.10.13Proven to decrease screening recall rates and generate revenue despite the lack of reimbursement for the additional imaging, 3D breast tomosynthesis has taken the mammography market by storm. However, despite proving itself as a valuable asset to women’s health, vendors have been slow to enter the tomosynthesis market.

It has been over two years since Hologic received FDA clearance for the Selenia Dimensions Tomosynthesis system. Uncontested in the U.S. market during this 2+ year period Hologic has made improvements to their tomosynthesis technology such as those detailed in Julie Johnson’s article on C-View Imaging from June of this year.

Tomosynthesis breast imaging is not new to the other vendors in the mammography market, outside the U.S. at least. Hologic’s potential top two competitors in the U.S. mammography market, GE Healthcare and Siemens, both already offer tomosynthesis solutions internationally. But, while it has been several years since the introduction of breast tomosynthesis in the United States, Hologic remains the only vendor to offer a viable tomosynthesis breast imaging solution.

This is largely to blame on the rigorous, lengthy PMA (Premarket Approval) review process. Unlike 510(k) clearance which requires that a system be Substantially Equivalent (SE) in comparison to a predicate device, PMA requires a vendor to prove the system’s safety and effectiveness as well as provide scientific evidence. PMA applications almost always require the submission of documented clinical research data, which takes time to compile.

But while the FDA has held back Hologic’s competition in the US market thus far, this may not be the case for long.

In a July 30th press release GE revealed that they have submitted the final module of their PMA documents for FDA review. This final module contains clinical study results as well as manufacturing information. When and if FDA approved, GE’s tomosynthesis will be an add-on option to their Senographe Essential system.

Siemens is currently in the process of collecting clinical data for PMA submission. Their MAMMOMAT Inspiration system is capable of tomosynthesis and can be upgraded when and if Siemens receives FDA approval for tomosynthesis.

While there are a lot of whens and ifs associated with FDA approval, one thing is certain; the currently monopolized mammography tomosynthesis market could use some healthy competition.

 

Rachael Bennett, BHS, R.T.(R)(T)
ABOUT THIS EXPERT
Rachael Bennett, BHS, R.T.(R)(T), Clinical Analyst — Ms. Bennett joined MD Buyline in 2008 with seven years of clinical experience in the medical field. Ms. Bennett is the primary clinical analyst for linear accelerators, stereotactic radiosurgery, mammography systems, biopsy systems and other radiation oncology and women’s health capital equipment codes. She graduated from Baylor Allied Health School with a major in radiography and went on to specialize in radiation therapy at Washburn University. She currently holds registries as both a radiographer and radiation therapist through the American Registry of Radiologic Technologists (ARRT).