Hologic Inc has received final approval from the Food and Drug Administration (FDA) for a Premarket Approval (PMA) supplement which covers the use of the Company''''s proprietary DirectRay amorphous-selenium, direct-to-digital image receptor for its Lorad Selenia Full Field Digital Mammography (FFDM) 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.
Hologic''''s Lorad division is a leader in the design and production of leading-edge imaging systems focused on the early detection of breast cancer. The patented digital image receptor, produced by Hologic''''s DirectRay division in Newark, Delaware, 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.
According to Jack W. Cumming, Hologic''''s President and CEO, "Approval of Selenia has been a much anticipated milestone for the Company, and allows us to immediately begin our marketing activities in the United States and to launch our commercialization efforts of this important product. With an installed base of over 10,000 mammography systems, Lorad has long been recognized as the technology innovator. Demand to date from Europe has been encouraging and we are now planning for the ramp-up of our production capabilities. Our initial shipments of Selenia will begin this quarter. We are also planning to tap into the existing upgrade marketplace represented by the over 3,000 installed Lorad M-IV screen-film mammography systems that can be converted to direct-to-digital capability in the field. Early detection continues to be critical in saving lives, and we believe that Selenia will provide outstanding performance to aid physicians in the detection of breast cancer due to its image quality and dose utilization characteristics."