FDA Approves Stand-alone 3D Screening With Siemens Tomosynthesis Platform

Siemens Healthineers has announced that the Food and Drug Administration (FDA) has approved the use of 3D-only screening mammography utilizing the company’s Mammomat Inspiration with Tomosynthesis Option digital mammography system. The Siemens system is the first and only 3D digital breast tomosynthesis (DBT) platform to be approved by the FDA as a stand-alone screening and diagnostic system; all other mammography systems on the market require a combination of 2D and 3D examinations.

FDA approval of the 3D-only application follows a pivotal reader study in which participating radiologists demonstrated their ability to increase cancer detection at a lower radiation dose than combined 2D and DBT. In the study, radiologists decreased average recall rates by an average of 19 percent without the need for a 2D image.

“Siemens is proud to announce the availability of 3D-only screening with our Mammomat Inspiration with Tomosynthesis Option digital mammography system,” said Martin Silverman, Vice President of X-ray Products at Siemens Healthineers. “Although this is the first breast tomosynthesis solution on the market to demonstrate statistically superior results to 2D as a stand-alone breast exam, we know many providers will continue using 3D tomosynthesis as an adjunct to 2D screenings. Those providers who use our platform, however, will do so with confidence, knowing our 3D is a proven stand-alone option.”

Siemens’ Tomosynthesis Only Option is available on the company’s Mammomat Inspiration and Mammomat Inspiration Prime Edition digital mammography systems.

Siemens healthcare rebrands to Healthineers

Siemens Healthcare unveiled its new brand name Siemens Healthineers. The new brand underlines Siemens Healthcare's pioneering spirit and its engineering expertise in the healthcare industry. It is unique and bold and best describes the Healthcare organization and its people – the people accompanying, serving and inspiring customers – the people behind outstanding products and solutions.

"We have an exceptional track record of engineering and scientific excellence and are consistently at the forefront of developing innovative clinical solutions that enable providers to offer efficient, high quality patient care. Going forward as Siemens Healthineers, we will leverage this expertise to provide a wider range of customized clinical solutions that support our customers business holistically. We are confident in our capability to become their inspiring partner on our customers' journey to success", explained Bernd Montag, CEO of the company. "Our new brand is a bold signal for our ambition and expresses our identity as a people company – 45,000 employees worldwide who are passionate about empowering healthcare providers to optimally serve their patients."

As part of its Vision 2020 strategy Siemens AG announced nearly two years ago that its healthcare business would be separately managed as a company within the company with a new organizational setup. Siemens Healthineers will continue to strengthen its leading portfolio across the medical imaging and laboratory diagnostics business while adding new offerings such as managed services, consulting and digital services as well as further technologies in the growing market for therapeutic and molecular diagnostics.

The name of the legal entities will remain unchanged.

A press release can be found from Siemens website by clicking this link.