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Press release from PR Newswire

FDA Clears Hologic's Specimen Radiography System

Tuesday, October 18, 2011

FDA Clears Hologic's Specimen Radiography System14:00 EDT Tuesday, October 18, 2011New Trident System Offers Improved Image Quality and Streamlined Workflow in the Verification of Breast Biopsy SamplesBEDFORD, Mass., Oct. 18, 2011 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that the U.S. Food and Drug Administration (FDA) has cleared the Company's Trident specimen radiography system. The system uses Hologic's proprietary direct digital detector technology to produce high quality images for rapid verification of tissue specimens such as breast biopsy samples. Trident is a state-of-the-art, mobile system designed to reduce procedure steps, streamline workflow and give physicians increased confidence in the accuracy of their procedures. To view the multimedia assets associated with this release, please click: http://multivu.prnewswire.com/mnr/hologic/50097/(Photo:  http://photos.prnewswire.com/prnh/20111018/MM86572 )?Our new Trident specimen radiography system takes advantage of the valuable insights we have gained as the global leader in digital mammography,? said Peter Soltani, Senior Vice President & General Manager - Breast Health. ?Our goal is to provide leading-edge technologies that improve the diagnostic precision of procedures and create a better experience for patients and their healthcare providers. The Trident system more than meets these expectations and is an example of our commitment to excellence in breast cancer detection and diagnosis.?Gary M. Levine, M.D., Director of Breast Imaging at Hoag Breast Care, Hoag Memorial Hospital Presbyterian, Newport Beach, California, was one of the radiologists who evaluated the system. "Hologic's Trident system addresses many market needs by providing exceptionally high image quality, rapid verification of tissue samples and extreme ease of use," stated Dr. Levine. "Trident is a valuable tool in helping to improve the delivery of breast care for women." About Trident Specimen RadiographyFrequently, breast specimen imaging is performed directly on the facility's mammography system. This takes away from the time the system could be used for normal screening and diagnostic exams. In addition, if the clinician leaves the procedure to confirm the specimen image, the patient often needs to stay under anesthesia and/or in compression during this time.The Trident specimen radiography system is designed for use in the operating room where breast tissue is surgically excised, and in biopsy suites where minimally-invasive, stereotactic or ultrasound breast biopsies are performed.The new system is self-contained and eliminates the need for samples to be taken to the radiology department for X-ray imaging. Performing the verification in the same room as or within close proximity from the procedure improves workflow, thus reducing procedure time for the patient. The Trident system's selenium-based detector, with its 12 cm x 14 cm active imaging area, provides high quality imaging for the majority of breast specimens. The system's intuitive, user-friendly interface facilitates seamless workflow without the need for extensive training or experience. For even greater efficiency, the system offers one-button Automatic Exposure Control and one button export to PACS (Picture Archiving and Communication System) or to the Hologic SecurView diagnostic workstation. About Hologic, Inc.Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostics products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women. Hologic's core business units are focused on breast health, diagnostics, GYN surgical, and skeletal health. Hologic provides a comprehensive suite of technologies with products for mammography and breast biopsy, breast magnetic resonance imaging, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia and uterine fibroids, permanent contraception, osteoporosis assessment, preterm birth risk assessment, mini C-arm for extremity imaging and molecular diagnostic products including HPV and reagents for a variety of DNA and RNA analysis applications. For more information, visit www.hologic.com.Hologic, SecurView and Trident and associated logos are trademarks and/or registered trademarks of Hologic, Inc. and/or its subsidiaries in the United States and/or other countries.Forward Looking Statement Disclaimer This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Trident specimen radiography system. There can be no assurance the system will achieve the benefits described herein and that such benefits will be replicated in any particular manner with respect to an individual patient as the actual effect of the use of the Trident system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Hologic expressly disclaims any obligation or undertaking to release publicly any updates or revisions to the data or statements presented herein to reflect any change in the Company's expectations or any change in events, conditions or circumstances on which any such data or statements are based.Contact:Jim Culley, Ph.D.Olga KaragiannisCorporate Marketing Corporate MarketingHologic, Inc.Hologic, Inc.Tel: 781.999.7583Jim.Culley@hologic.comTel: 781.761.7069Olga.Karagiannis@hologic.comSOURCE Hologic, Inc.