FDA Approves Siemens’ Tomosynthesis Add-On For Mammography

April 23, 2015

The tomosynthesis option for the Siemens’ MAMMOMAT Inspiration digital mammography system received FDA approval.

The U.S. FDA has approved the tomosynthesis option for Siemens Healthcare’s MAMMOMAT Inspiration digital mammography system, Siemens announced today.

The add-on option includes Siemens’ breast tomosynthesis algorithm, which reconstructs multiple 2D images of the breast into an approximation of a 3D image, enabling detection of tumors that are hidden by overlapping breast tissue, Siemens said in a release. The resulting 3D image enables more accurate diagnosis than standard 2D mammography and reduces the number of false-positives, Siemens said.

Limitations in conventional analog mammography and full-field digital mammography include the display of a 3D structure of the breast on a 2D level, which hampers the physicians’ ability to identify certain types of tumors, Siemens explained in the release. In tomosynthesis mode, the X-ray tube of the MAMMOMAT Inspiration system rotates in a circular motion around the breast to acquire an image every two degrees, while moving through an angular range of 50 degrees, the release said. The resulting 25 projections are reconstructed as 3D digital breast tomosynthesis images.

This dataset will help clinicians better analyze the type and size of breast lesions, as well as microcalcifications, Siemens said.

“We know that in clinical practice, this increased diagnostic accuracy [of tomosynthesis] also means fewer diagnostic biopsy procedures and fewer anxiety-inducing recalls, which typically contributes to both improved patient outcomes and reduced cost,” Gregory Sorenson, MD, president and CEO of Siemens Healthcare North America, said in the release.[[{"type":"media","view_mode":"media_crop","fid":"34515","attributes":{"alt":"Siemens Healthcare’s MAMMOMAT Inspiration ","class":"media-image media-image-right","id":"media_crop_8474416794736","media_crop_h":"0","media_crop_image_style":"-1","media_crop_instance":"3679","media_crop_rotate":"0","media_crop_scale_h":"0","media_crop_scale_w":"0","media_crop_w":"0","media_crop_x":"0","media_crop_y":"0","style":"height: 213px; width: 160px; float: right;","title":"Siemens Healthcare’s MAMMOMAT Inspiration ","typeof":"foaf:Image"}}]]