MAMMOMAT Revelation

FDA clears Siemens MAMMOMAT Revelation mammo platform

March 29, 2018
by John R. Fischer, Senior Reporter
Following a nod from the FDA, Siemens Healthineers is now gearing up for the release of its MAMMOMAT Revelation, a premium mammography platform designed to improve diagnostic confidence and earlier lesion detection in patients with dense breast tissue.

Equipped with HD Breast Tomosynthesis and InSpect integrated specimen imaging, the solution enables one-click targeting of suspicious areas and the ability to assess biopsy samples in real time on the same system, thereby improving patient experience and expanding the capabilities of precision medicine.

“Once specimens are acquired during a biopsy, the technologist has to leave the patient to find an open system to X-ray the specimen, or rely on a standalone specimen imager that may be located in another area,” Pam Cumming, senior director of product marketing/womens health, Siemens Healthineers North America, told HCB News. “This capability is actually integrated right into the system so the technologist never has to leave the patient’s side or release her from compression, which might require additional dose to re-target. She can always be with her and keep her anxiety level down, minimize time in compression, and work more efficiently.”

Nearly half of women undergoing mammograms in the U.S. have dense breast tissue, making it challenging for conventional systems to detect lesions. MAMMOMAT Revelation offers automated breast density measurement during exams for personalized risk stratification and more personalized care.

The addition of HD Breast Tomosynthesis provides the solution with the widest image acquisition angle available at 50 degrees.

This creates a high depth resolution for better separation of overlapping breast tissue and better 3-D visualization of abnormalities in breast tissue, qualities that enable the technologist to use one-click targeting with +/- 1mm accuracy to pinpoint the location of these abnormalities.

Technologists can also scan biopsies without leaving the room by using the solution’s InSpect integrated specimen imaging tool. The biopsy specimens are placed inside a small plastic box that slides onto the biopsy device, and the tube head automatically collimates to this area on the detector. The specimen images appear on technologist’s acquisition workstation within seconds.

This allows the technologist to remain with the patient to provide support and reduce feelings of anxiety.

Those with inconclusive cases have the option of undergoing MAMMOMAT Revelation’s titanium contrast-enhanced mammography, a cost-effective alternative to MR imaging, thereby reducing scheduling conflicts and offering reassurance to the patient.

In addition, the solution’s Personalized Soft Compression capabilities can adjust breast compression to a level that suits the patient’s anatomy, utilizing ergonomic SoftComp Paddles to improve breast positioning, decrease discomfort, and provide more consistent image quality.

Cumming says the wide angle acquisition technology of the MAMMOMAT Revelation has FDA approval for screening mammograms using 3-D only, eliminating the need to acquire 2D FFDM views and resulting in fewer views and less exposure to dose among patients without compromising specificity and sensitivity.

She notes that studies are being done, especially in Europe, to further explore how this could impact what mammography of the future might look like. The goal is to work as efficiently as possible, at the lowest possible dose, without compromising diagnostic accuracy.

“I think what’s exciting is not only that the better depth resolution of the wide angle technology provides better image quality than other systems, but that the power of the technology and the results from these studies mean that we begin to shape the discussion around what more we can do for women down the road. We start thinking about leveraging the strength of the evolving DBT technologies and how might that impact clinical practice? That takes time. But the technology is starting to speak for itself in that regard.”

Siemens is currently preparing for its immediate release. The solution, introduced at RSNA in November, is CE marked and available in parts of Europe.