Rock and Roll: Hologic, Inc. (Nasdaq: HOLX chart, msgs), a leading provider of specialized medical imaging equipment for women's health and digital radiographic applications, today announced receipt of
marketing clearance from the Food and Drug Administration (FDA) for its Lorad Affinity Mammography System. Lorad, a division of Hologic located in Danbury, Connecticut, is an industry leader in the production of innovative mammography and minimally invasive breast biopsy systems.
The Lorad Affinity is a high performance screen-film mammography system specifically developed to fill a market need for a cost-effective product, with performance characteristics similar to high-end systems. The Affinity System will be marketed globally and will be available in configurations utilizing Lorad innovations to improve mammographic image quality, including its award winning High Transmission Cellular (HTC(TM)) Grid technology and exclusive Fully Automatic Self-adjusting Tilt (F.A.S.T.) compression paddle.
According to Jack W. Cumming, CEO and President of Hologic, "Receiving FDA marketing clearance for the Affinity is one more step in our ongoing initiative to provide the highest quality breast imaging products to meet the needs of every facet of the market. The Affinity product line will help strengthen Hologic's overall leadership position in breast imaging by providing expanded product offerings for cost-sensitive segments of the international and domestic marketplace. Development of the Affinity, combined with our
recent advances in digital mammography, our demonstrated expertise in premier screen-film mammography systems and our strength in stereotactic biopsy systems provides a strong foundation for technological superiority in every breast imaging product line."
Commenting on the FDA action, Pete Kershaw, Vice President and General Manager of Lorad said, "We are pleased to receive confirmation of marketing clearance from the FDA for the Affinity Mammography System. We believe this system provides a highly effective solution for value-driven customers seeking a quality product to meet their mammography needs. The introduction of this versatile system to the mammography community provides effective, expanded choices for this market niche and advances Lorad's commitment to improving women's healthcare by producing high-quality products for the early detection of breast cancer."
The Company expects full commercial production of the Affinity to begin in the first quarter of 2002. |
