Navigation Links
Hologic's Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System Receives Favorable Votes From FDA Advisory Panel
Date:9/24/2010

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
'/>"/>

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

Page: 1 2 3 4

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:
*Name:
*Comment:
*Email:
(Date:1/14/2014)... FRAMINGHAM, Mass. , Jan. 14, 2014 ... a leading innovator of less invasive, miniaturized circulatory support ... failure, today announced that it expects revenues for the ... bringing expected full-year 2013 revenues to approximately $208 million. ...
(Date:1/14/2014)... The Brandeis Medical Center, led by Dr. Emmanuel Brandeis ... affordable laser tattoo removal experience with the advanced Astanza Duality laser ... high quality cosmetic services with cutting edge medical technology and offering ... California has seen a dramatic increase in the presence ...
(Date:1/14/2014)... Animal Emergency Critical Care, a LifeCentre partner practice, located at ... is the first in Loudoun County to ... Susan M. Barnes , Medical Director, is a well-seasoned veterinarian ... Cole Taylor , are avid scuba divers. "As altitude skiers and ...
Breaking Medicine Technology:HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 2HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 3HeartWare International Announces Preliminary Fourth Quarter 2013 Revenues 4Beverly Hills Physician Features Tattoo Removal with the Astanza Duality Laser, Offers $99 Special 2Hyperbaric Veterinary Medicine (hvm) Announces Animal Emergency Critical Care Installs A Small Animal Hyperbaric Chamber 2
... Three Independent Clinical Trials Initiated with Teplizumab Manufactured at ... ... that its Protege trial is actively enrolling adults and children ages,8 to ... evaluate the safety and efficacy of three teplizumab dosing,regimens administered at the ...
... versus 26.2 for ... Vidaza compared to ... conventional ... modifier to show survival benefit in cancer Stratified log-rank p-value = 0.0001, Hazard ...
Cached Medicine Technology:MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus 2MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus 3MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus 4Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS) 2Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS) 3Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS) 4Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS) 5Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS) 6Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS) 7Vidaza Significantly Extends Overall Survival by 74% in Phase 3 Trial in Myelodysplastic Syndromes (MDS) 8
(Date:7/10/2014)... health-conscious people around the globe have taken antioxidant supplements ... one of the paths to good health and a ... antioxidant supplements have repeatedly dashed the hopes of consumers ... Virtually all such trials have failed to show ... several trials antioxidant supplementation has been linked with increased ...
(Date:7/10/2014)... Manchester scientists have shown that a new drug could prove ... aggressive form of lung cancer. , Scientists from the Cancer ... and part of the Manchester Cancer Research Centre, teamed up ... in 2010, to test a drug known as AZD3965 ... published in the journal Clinical Cancer Research , also ...
(Date:7/9/2014)... reveal that sudden, acute episodes of low back pain ... humidity, air pressure, wind direction and precipitation. Findings published ... of the American College of Rheumatology (ACR), indicate that ... higher wind speed or wind gusts, but was not ... Organization (WHO) nearly everyone experiences low back pain at ...
(Date:7/9/2014)... CHICAGO After Susan Wakulich was told she had an ... lay ahead of her. , "I was devastated," said Wakulich, ... suburbs. "I knew this was a serious diagnosis. Then I ... trial that involved a less invasive procedure. It was something ... is participating in a multi-center U.S. clinical trial to evaluate ...
(Date:7/9/2014)... into the metabolism of stromal support cells and immune ... these cell types in the development of diseases ... and cancer. That was the conclusion of a review ... the leading journal Nature . , Prof. Peter ... call. The metabolism of cancer cells has been examined ...
Breaking Medicine News(10 mins):Health News:How antioxidants can accelerate cancers, and why they don't protect against them 2Health News:New drug active against most aggressive type of lung cancer cells 2Health News:Low back pain? Don't blame the weather 2Health News:New type of stent could help some brain aneurysm patients 2Health News:Wake-up call for more research into cell metabolism 2
... price of efavirenz 600mg tablets (Stocrin) for developing countries that ... ,It is the second price cut in a ... efavirenz cheaper than a generic import in Thailand, where a ... from India. ,For least developed countries and ...
... case management that takes a patient’s specific culture ... decrease the incidence of diabetes-related complications over the ... ,"Better management results in reduced long-term complications, such ... lead researcher Todd Gilmer, Ph.D. ,The ...
... Japanese researchers have successfully developed artificial teeth that they ... eventually help with similar procedures in humans. ... a single cell implanted into the mouths of adult ... in humans, reported the online edition of Australia's The ...
... Insufficient sleep at night could have an adverse effect ... that shows// how important the evening slumber is for ... University Of Colorado School Of Medicine and other researchers ... out by students attending middle school or high school, ...
... not worry about getting their bodies back into shape immediately, ... body has enough to do after a baby arrives," said ... ,New mothers also have to reckon with fatigue ... Pfarrer of the insurer DAK in Hamburg. And nursing a ...
... have literally found the needle in the haystack as ... help to discover hitherto unknown genetic material that causes ... in the prevention and treatment of autism has been ... all part of an international team from 8 countries ...
Cached Medicine News:Health News:Culturally Specific Diabetes Management Helps Low-Income Patients 2Health News:Sleep Disturbances Could Affect Performances in School 2Health News:New Gene Linked to Autism Discovered 2
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... reference laboratory and a worldwide leader in ... an extensive test menu of highly complex ... anatomic pathology. Owned by the University of ... half of the nation's university teaching hospitals ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
... ARUP Laboratories is a national reference laboratory ... research and development. ARUP offers an extensive ... medical tests in clinical and anatomic pathology. ... Laboratories' clients include more than half of ...
Medicine Products: