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Food and Drug Administration (FDA) Approves the American College of Radiology (ACR) To Accredit Hologic's Lorad SeleniaT Full Field Digital Mammography Systems Action Clears Barrier to "All-Digital" Mammography Suites for Hologic Customers BEDFORD, Mass. (September 16, 2003) - Hologic, Inc., (NASDAQ: HOLX) today announced that effective September 15, 2003 the American College of Radiology (ACR) became the FDA-approved accrediting body for Lorad Selenia full field digital mammography systems. Hologic is a leading provider of women's diagnostic imaging systems and state-of-the-art digital radiology systems. The Lorad Selenia is manufactured in Hologic's facility in Danbury, Connecticut. Prior to this approval, facilities purchasing the Lorad Selenia were required to file directly with the FDA for an extension of their existing Mammography Quality Standards Act (MQSA) certification to include the new system and were also required to have a screen-film system available. Following the appointment of ACR as the accrediting body for the Lorad Selenia, facilities purchasing the full field digital mammography system will go directly to the ACR for accreditation and will no longer be required to have a screen-film system. "We are very pleased with this action by the FDA because it will simplify accreditation requirements for our customers and provide a more efficient registration process," said Jack W. Cumming, Hologic's Chairman and CEO. "It also removes a barrier for facilities planning to convert to an all-digital mammography environment. Since Hologic began commercial shipments of the Selenia system earlier this year, many of our customers have expressed significant interest in developing a filmless breast imaging center because of the inherent efficiencies they see in such a setting. Approval of the ACR as the accrediting agency for the Selenia will enable facilities to proceed with those plans without the expense and effort required to maintain both a screen-film and digital systems. This step forward should also allow our existing customer base with similar plans to complete their transition to all-digital mammography." As of September 15, 2003 the FDA will begin contacting facilities that have previously installed Selenia systems to advise them of the steps to take to gain accreditation for these units. About Hologic
Hologic, Inc. is a leading developer, manufacturer and supplier of medical imaging systems dedicated to serving the healthcare needs of women, and a leading developer of state-of-the-art digital imaging technology for general radiography and mammography applications. Hologic's core business units are focused on osteoporosis assessment, mammography and breast biopsy, direct-to-digital x-ray for general radiography applications and mini C-arm imaging for orthopedic applications. Forward Looking Disclaimer
This News Release contains forward-looking information that involves risks and uncertainties, including statements about Hologic's plans, objectives, expectations and intentions. Such statements include, without limitation, statements regarding the simplification and efficiencies of the accreditation and registration process, and potential cost savings to Hologic customers, as a result of the appointment of the American College of Radiology as an FDA-approved accredited body for the Lorad Selenia. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual results to differ materially from those anticipated. Factors that could cause actual results to materially differ include, without limitation; substantial reliance on the efforts of the American College of Radiology to achieve the simplification and efficiencies anticipated; uncertainties inherent in the development of new products and the enhancement of existing products, including technical and regulatory risks, such as the ability to obtain FDA and corresponding foreign regulatory authority clearance or approval to market products developed, cost overruns and delays; the risk that newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated; the early stage of market development for digital x-ray products; Hologic's ability to predict accurately the demand for its products and to develop strategies to address its markets successfully; risks relating to Hologic's reliance on a single source of supply for some key components of its products; the need to comply with especially high standards in the manufacture of digital x-ray products; Hologic's ongoing ability to satisfy financial and other covenants in its credit and lease agreements; technical innovations that could render products marketed or under development by Hologic obsolete; competition; and reimbursement policies for the use of Hologic's products. Other factors that could adversely affect Hologic's business and prospects are described in Hologic's filings with the Securities and Exchange Commission. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in Hologic's expectations or any change in events, conditions or circumstances on which any such statement is based.
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