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| The Mammomat Inspiration digital mammography platform--Courtesy of Siemens Healthcare |
Just as the latest breast tomosynthesis equipment option has made it through the FDA with an approval for Siemens, startup VuComp has submitted its own PMA to gain approval for its computer-aided detection software for digital breast tomosynthesis images. The new approval offers another 3-D option to supplement traditional 2-D mammography, which recent research has shown aids in cancer detection and reduces the rate of patients recalled for further imaging.
The Siemens approval for its Mammomat Inspiration with Tomosynthesis Option is the latest advance for the 3-D imaging technology. In 2011, breast tomosynthesis kicked off with an approval for Hologic. Since then, GE Healthcare ($GE) gained FDA approval last year for its SenoClair, which combines 2-D and 3-D images. And in February, Koning gained an FDA approval for its 3-D computed tomography system that doesn't require breast compression.
In September, the FDA issued a statement advocating for innovation in 3-D imaging technology as it can improve physician's ability to detect tumors and diagnose cancers. That came after a study in the Journal of the American Medical Association (JAMA) last summer found that subsequent patient recalls were decreased and cancer detection rates were improved by adding the use of tomosynthesis to mammography.
The recent submission of a premarket approval application (PMA) by VuComp will further test the agency's commitment to 3-D imaging. It is the first to submit a PMA to the agency for an approval of computer-aided detection for digital breast tomosynthesis, the company said.
Its system uses computer vision algorithms to identify areas of images that are consistent with breast cancer. The FDA submission includes clinical trial data that compares computer-aided detection on images created via tomosynthesis and traditional mammography versus the analysis of mammograms alone.
VuComp anticipates an FDA approval for its tomosynthesis software and a subsequent launch by the fourth quarter this year. It could help reduce the burden on the radiologists who screen these images--tomosynthesis provides 50 to 100 times the amount of data as 2-D mammography, the company notes.
"DBT [digital breast tomosynthesis] clearly decreases the recall rates for screening mammography and increases invasive cancer detection," said Dr. Debra Somers Copit, Director of Breast Imaging at Einstein Healthcare Network and Associate Professor of Radiology at Jefferson Medical College. "Yet, there is a critical role for CAD [computer-aided detection] not only for the radiologist new to tomosynthesis, but also those who have had more experience, given the vastly increased amount of information presented to the reader."
As for Siemens, its newly approved system gives the option of both 2-D and 3-D breast screening. It moves in a circular motion around the breast to take an image at every two degrees through an angular range of 50 degrees; this process results in 25 projections that are used to construct a 3-D images.
"Our clinical data has demonstrated that the addition of Siemens' digital breast tomosynthesis to a patient's traditional 2-D digital mammogram increases detection of breast tumors," said Dr. Gregory Sorensen, President and CEO of Siemens Healthcare North America, in a statement. "We know that in clinical practice, this increased diagnostic accuracy also means fewer diagnostic biopsy procedures and fewer anxiety-inducing recalls, which typically contributes to both improved patient outcomes and reduced cost."
- here are the Siemens and VuComp releases