Hologic receives final FDA approval for digital mammography system

OCTOBER 3--Hologic Inc. (Bedford, MA; www.hologic.com/) received final approval from the US Food and Drug Administration (FDA) for a premarket-approval supplement that covers the use of the DirectRay amorphous-selenium, direct-to-digital image receptor for its LORAD Selenia full-field digital mammography system.

OCTOBER 3--Hologic Inc. (Bedford, MA; www.hologic.com/), a provider of women's diagnostic imaging systems and state-of-the-art digital radiography systems, received final approval from the US Food and Drug Administration (FDA) for a premarket-approval supplement that covers the use of the DirectRay amorphous-selenium, direct-to-digital image receptor for its LORAD Selenia full-field digital mammography system. The Selenia generates digital mammographic images that can be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems. Mammographic images can be interpreted on either hard-copy film or the Selenia soft-copy review workstation.

The patented digital image receptor, produced by Hologic's DirectRay division in Newark, DE, uses amorphous selenium technology to directly convert x-ray beams to electronic signals. Direct conversion preserves image sharpness by eliminating image degradation due to light scatter. This PMA supplement represents the first approval by the FDA of a mammography system using this advanced direct conversion technology.

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