Siemens gets PMA for FFDM unit

Siemens Healthcare has received U.S. Food and Drug Administration (FDA) premarket approval (PMA) for its Mammomat Inspiration full-field digital mammography (FFDM) system.

Featuring an amorphous selenium detector, Inspiration provides digital screening and diagnostic mammography, stereotactic biopsy, and upgrade capabilities to future technologies all on one system, according to the Malvern, PA-based vendor. More than 700 systems have been installed outside of the U.S.

Siemens is highlighting the patient experience of Inspiration, including its MoodLight LED light panel. This capability allows for a warmer environment by illuminating soft, pastel colors that can change dynamically throughout the day or be set on one color that best matches the environment, Siemens said.

Inspiration also includes three anode/filter combinations to match breast density and thickness. An Opdose feature automatically selects the appropriate anode/filter combination and the lowest radiation dose for individual breast characteristics, while its Opcomp function applies optimal breast compression, Siemens said.

In workflow features, Inspiration automatically opens the patient scheduler after an exam is finalized; selecting the next patient is the only mouse-click needed, Siemens said. Its tube head also instantly goes from the craniocaudal to the mediolateral-oblique position with one touch of a button, according to the vendor.

In addition, the operator interface of Siemens' syngo-based acquisition workstation (AWS) includes the generator console, allowing for a smaller footprint. Dose calculation has been optimized with a new adaptive exposure correction (AEC) algorithm, according to the firm.

A new OpView 2 image processing software package was specially designed for digital mammography, Siemens said. Siemens' AWS and syngo MammoReport also enable image viewing from multiple modalities on one screen.

Related Reading

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FDA eases rules on digital mammography devices, November 4, 2010

Siemens offers PERCIST tool for oncology, November 3, 2010

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