FDA approves breast tomosynthesis add-on for Siemens devices

The Food and Drug Administration (FDA) has approved a breast tomosynthesis add-on for Siemens Healthcare’s MAMMOMAT Inspiration digital mammography devices, adding another option for breast tomosynthesis in the United States.

For customers with the MAMMOMAT Inspiration and Inspiration Prime Edition low-dose mammography models, the Tomosynthesis Option is a software-driven add-on and requires no new physical hardware.

Jennifer Okken, senior manager of women’s health at Siemens Healthcare, said that the add-on’s 50-degree angle of acquisition is one of its most important features. The angle can capture 25 projections, which are then combined to produce 3D images of the breast.

“We feel strongly that the more projections you have, the better resolution that is in the image,” Okken told RadiologyBusiness.com in a phone interview. “It could potentially increase cancer detection.”

Physicians will still be able to perform 2D mammography with their MAMMOMAT Inspiration devices after the new breast tomosynthesis add-on is installed. Okken said it’s simple for physicians to go back and forth between 2D and 3D, depending on what the patient requires at the time of the exam.

There are approximately 600 MAMMOMAT Inspiration devices currently installed in the United States, and approximately 3,000 total throughout the world.

The add-on will be available by the week of April 27, Okken said, and Siemens is ready to deliver the software immediately. Providers will now also have the option to buy a MAMMOMAT Inspiration device with the breast tomosynthesis add-on software already installed.

Providers in Europe and South America have been using the software since 2009.

 

Michael Walter
Michael Walter, Managing Editor

Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.

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