FDA approves first standalone 3-D mammography system for Siemens

Mammomat Inspiration with Prime technology--Courtesy of Siemens

The use of 3-D mammography to complement a standard 2-D approach in breast cancer screening is becoming more standard. But all previous FDA approvals of mammography systems have included a combination of both 3-D and 2-D approaches. Now, Siemens ($SIE) has nabbed the first FDA approval for a 3-D digital breast tomosynthesis (DBT) system.

The use of 3-D is only expected to decrease patient recall rates by 19% on average and result in a lower radiation dose. The Mammomat Inspiration with Tomosynthesis Option digital mammography system also increases cancer detection compared to 2-D alone. An earlier iteration of the device combines both 3-D and 2-D options.

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

Earlier this month, Siemens Healthcare rebranded as Siemens Healthineers, a move that's broadly been mocked in the media. The conglomerate had already separated out healthcare as a separately managed business within the company.

Alongside the rebrand, Siemens, whose healthcare business is largely dominated by imaging, said it would expand in therapeutic and molecular diagnostics and add offerings in managed services, consulting and digital services.

Siemens has already announced a pair of deals in the scant time since the rebrand: the acquisition of molecular oncology diagnostic company New Oncology for an undisclosed sum, which will allow it to enter cancer Dx, and a partnership expansion with Case Western Reserve University to develop MRI fingerprinting.

- here is the release

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