Navigation Links
Hologic's Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System Receives Favorable Votes From FDA Advisory Panel

BEDFORD, Mass., Sept. 24 /PRNewswire-FirstCall/ -- 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 that the Radiological Devices Panel (Panel) of the U.S. Food and Drug Administration (FDA) today unanimously voted that Hologic's Pre-Market Approval (PMA) demonstrated both the effectiveness and safety of the Company's Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system, "Selenia Dimensions 3-D." In addition, the Panel voted in favor that the benefits of this new technology outweigh the risks.

Following today's FDA Panel meeting, which was held in Gaithersburg, Maryland, Hologic will work with the FDA on next steps for approval of its 3-D digital mammography system. While the Panel's favorable vote is advisory in nature, the FDA will consider it in its final review of Hologic's PMA application for the Selenia Dimensions tomosynthesis system.

"Our Selenia Dimensions 3-D technology marks tremendous progress in the early diagnosis of breast cancer," said Jay A. Stein, Co-Founder and Chief Technical Officer. "The system is designed to increase accuracy when screening women for the presence of cancerous tissue, and to enable a more precise characterization of suspicious lesions. I speak for all of Hologic in voicing great satisfaction that the FDA Panel has weighed in so positively in favor of this valuable new tool in the battle to limit breast cancer mortality."

Hologic's Selenia Dimensions 3-D digital mammography tomosynthesis system is a new method for breast cancer screening and diagnosis. Unlike current mammography systems, which generate a two-dimensional (2-D) image, breast tomosynthesis produces a three-dimensional image. We believe our multicenter clinical study has demonstrated that compared to 2-D digital mammography alone, 3-D digital tomosynthesis used in combination with 2-D digital mammography has the potential to reduce recall rates and improve cancer detection.

Hologic's Selenia Dimensions 3-D digital mammography tomosynthesis system is presently commercially available outside the United States, including countries in Europe, Latin America and Asia. In North America, commercial systems are installed in Canada and Mexico. In the United States, Selenia Dimensions is currently available as a two dimensional only system that can be upgraded to do breast tomosynthesis (3-D) imaging when and if the product is approved by the FDA.

"We are extremely pleased with the outcome of today's FDA Panel meeting," said Rob Cascella, President and Chief Executive Officer. "Hologic has worked diligently on the development of breast tomosynthesis to overcome the primary limitation of the existing 2-D imaging technology, which is that the superimposition of normal breast anatomy may mask a breast cancer. Our Selenia Dimensions platform represents the next phase in breast cancer detection - fast, high-quality 2-D and 3-D digital tomosynthesis imaging of the breast. We look forward to working with the FDA to help complete the review process and bring this important new tool to radiologists to help save more women's lives."

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, radiation treatment for early-stage breast cancer, cervical cancer screening, treatment for menorrhagia, 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

Hologic, Dimensions and Selenia, 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 DisclaimerThis News Release contains forward-looking information that involves known and unknown risks and uncertainties, including statements about the outcome of the Panel review of Hologic's Selenia Dimensions digital breast tomosynthesis system, and the anticipated benefits of that system. The Panel review is only one step in the FDA's review process and its vote on safety and efficacy is advisory only. Hologic is unable to predict the outcome of the FDA's final review of its PMA. There can be no assurance that the FDA would approve Hologic's system on a timely basis, if at all. In addition, even if approved, the FDA could impose conditions to such approval that would significantly limit the use or commercialization of the system. Moreover, there can be no assurance the system will achieve the anticipated benefits described herein, or 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 system can only be determined on a case-by-case basis depending on the particular circumstances and patient in question. Among other things, newly introduced products may contain undetected errors or defects or otherwise not perform as anticipated. The risks and uncertainties included above are not exhaustive. Other factors that could adversely affect the Company's business and prospects are described in the Company's filings with the Securities and Exchange Commission. 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:

Deborah GordonVice President, Investor RelationsHologic, Inc.(781) 999-7716

SOURCE Hologic, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cardiac Dimensions® Announces Presentation of 12-Month Follow-up Data of TITAN™ Trial at European Society of Cardiology Meeting
2. ProUroCare Medical Completes Clinical Trial at Second Study Site Using Digital Prostate Imaging Technology
3. Verathon Introduces the GlideScope(R) Cobalt Advanced Video Laryngoscope (AVL); New Digital Technology Facilitates Quick Intubations
4. Escalon(R) Subsidiary Escalon Digital Solutions Announces Release of Web-Based AXIS(TM) Image Management System
5. Now Approved: Fujifilms FDR AcSelerate Direct Digital DR System
6. World Renowned Physician and Thought Leader Dr. Eric J. Topol to Highlight Digital Medicine Revolution at International CES 2010
7. Womens Digital Imaging Using DXA Total Body Fat Analysis to Help Patients in Weight Management and Fitness Programs
8. Frost & Sullivan to Speak at 2010 International Consumer Electronics Digital Health Summit
9. Varian Medical Systems to Highlight the Latest Digital Detectors, X-ray Tubes and Cancer Treatment Technology at the Radiological Society of North America (RSNA) Annual Meeting in Chicago
10. Waters SDMS Vision Publisher Now Certified Compliant with SAFE-BioPharma Digital Standard
11. Raytheon BBN Technologies Licenses Stereo Digital Mammography Technology to FUJIFILM Corporation
Post Your Comments:
(Date:11/25/2015)... DUBLIN , Nov. 25, 2015 /PRNewswire/ ... announced the addition of the "Global ... to their offering. --> ... "Global Brain Monitoring Devices Market 2015-2019" ... Research and Markets ( ) ...
(Date:11/25/2015)...  Linden Care, LLC, a retail specialty pharmacy focused ... suffering from chronic pain, said today that it is ... (TRO) enjoining Express Scripts from unilaterally terminating the Pharmacy ... --> --> The company said that ... --> --> In ...
(Date:11/25/2015)... Nov. 25, 2015  Henry Schein, Inc., the world,s ... office-based dental, medical and animal health practitioners, will unveil ... Henry Schein ConnectDental® Pavilion , which brings together ... open solutions designed to help any practice or laboratory ... for a schedule of experts appearing at the ...
Breaking Medicine Technology:
(Date:11/25/2015)... ... November 25, 2015 , ... Finnleo, a leader in the ... several models of traditional and far-infrared saunas. , For traditional saunas, Finnleo ... most traditional Finnish sauna wood, and Finnleo uses only European Grade A Nordic White ...
(Date:11/25/2015)... ... 2015 , ... On November 10, 2015, Bohrer Brady, LLC filed a class ... of a home health care worker who provided companionship services for the elderly, ill ... employed by Humana, Inc., Humana at Home, Inc., and SeniorBridge Family Companies (CT), Inc. ...
(Date:11/25/2015)... ... November 25, 2015 , ... On November 25, 2015, officials of ... network, announced the release of a new cutting edge recovery program that has been ... working with drug- and alcohol-addicted individuals with the purpose to free addicts from the ...
(Date:11/25/2015)... ... November 25, 2015 , ... ... certified facial plastic surgeon specializing in both surgical and non-surgical treatments, announced the ... Spa at Hobgood Facial Plastic Surgery. , Highly trained and nationally recognized ...
(Date:11/25/2015)... ... ... Today, Mothers Against Drunk Driving (MADD) learned that the number of ... time since 2011. In 2014, there were 9,967 fatalities involving an alcohol impaired driver, ... Traffic Safety Administration (NHTSA), 32,675 people were killed in traffic crashes in 2014. Drunk ...
Breaking Medicine News(10 mins):