GE’s SenoClaire technology won the same indication that the FDA had previously reserved for digital mammography, meaning the company can market SenoClaire for use in creating 2D images as well as for producing 3D images for screening and diagnosing breast cancer. The FDA further granted indication to use the system for "additional diagnostic workup of the breast," according to the approval order.
The win makes GE the 2nd company with a tomosynthesis system approved in the U.S., putting rival Hologic (NSDQ:HOLX) on alert. Hologic issued a note via its corporate Twitter account congratulating GE on the win on Friday, Aug. 29, before GE had made its own announcement.
A Hologic spokesperson declined to comment on the breaking news.
GE had planned to issue a statement after the holiday weekend, but the company has already updated its website with marketing information about the SenoClaire tomosynthesis system, which can be added to Senographe Essential and Senographe Care digital mammogram systems already installed in clinics. The FDA has also updated its database and published the approval order for the device.
"GE’s SenoClaire breast tomosynthesis is a 3-dimensional imaging technology that uses a low-dose short X-ray sweep around the compressed breast with only 9 exposures," according to the website. "This imaging technique is designed to separate the tissues and to reduce the overlapping of structures, which represents a limiting factor in standard 2D mammography."
The SenoClaire system uses a "step-and-shoot" method that brings the system to a complete stop before taking each exposure, reducing blur associated with motion so that images are sharp and in higher contrast.
In addition to the new exposure method, SenoClaire also includes GE’s ASiR image reconstruction software, which brings out microcalcifications in tissue better than the traditional Filtered Back Projection algorithm, according to GE.
The SenoClaire technology has been available in the European Union since GE won approval there in July 2013. The company filed for U.S. approval just weeks later.
Clinical trials have found that tomosynthesis helps reduce radiation exposure in screening and also helps find cancers in dense breast tissue, a barrier for traditional mammography. Dense breast tissue has been associated with an increased risk of cancer as well as a lower likelihood that it’ll be caught in a mammogram.
SenoClaire features "Automatic Optimization of Parameters" technology to identify areas of dense tissue and automatically select the best settings to produce the highest-quality image while keeping radiation exposure to a minimum.