Παρασκευή, 14 Ιουνίου 2013

http://www.auntminnie.com/index.aspx?sec=eba&sub=eml&pag=dis&itemId=103650&wf=5471

Users ranked Hologic digital mammography systems higher than all other systems in the recently published KLAS Women's Imaging Report. The # 1 ranked system, Selenia Dimensions 2D, was tops in 19 of the 25 measures users were asked about.
» Read more below or access the KLAS website


APPROVALS
 
FDA Approves New Low-dose Hologic 3D Mammography (Breast Tomosynthesis) Solution

Hologic's C-View 2D imaging software was approved by the U.S. Food and Drug Administration (FDA) in May 2013. C-View 2D images may now be used in place of the conventional 2D exposure required as part of a Hologic 3D mammography screening exam.
C-View 2D images may be used in place of traditional 2D images
C-View 2D images may be used in place of traditional 2D images, eliminating the need for a separate 2D exposure in a breast tomosynthesis exam. C-View images are generated from the 3D tomosynthesis data acquired during the mammography exam, eliminating the need for additional 2D exposures.
The combination of Hologic's 3D and C-View 2D images results in less time under compression for greater patient comfort and a lower radiation dose, while still providing the 2D images required as part of Hologic's FDA-approved 3D mammography screening exam.

 
ACR Coding Guidance for C-View Images*

On May 28th, the American College of Radiology (ACR) posted coding guidance for the C-View software. "When a screening breast tomosynthesis study is performed using the Hologic C-View for reconstruction of a two-dimensional tomosynthesis dataset, it is appropriate to report the unlisted diagnostic procedure code 76499 to describe the breast tomosynthesis study and HCPCS Level II "G" code G0202, Screening Mammography, producing direct digital image, bilateral, all views to describe the reconstruction of the two-dimensional tomosynthesis dataset."

SCREENINGDIAGNOSTIC
ProcedureCPT CodeProcedureCPT Code
2D imageG0202 (bilateral)2D imageG0204 (bilateral) 
or
G0206 (unilateral)
Breast tomosynthesis76499Breast tomosynthesis76499
  
C-View Option 2D image generated from 3D image setG0202 (bilateral)C-View Option 2D image generated from 3D image setG0204 (bilateral) 
or
G0206 (unilateral)
Breast tomosynthesis76499Breast tomosynthesis76499


NEW RESEARCH

First Large-Scale U.S. Population-Based Study (The Rose Study) Shows Hologic's 3D Technology Significantly Reduces Recall Rates While Simultaneously Improving Cancer Detection

The study, “Implementation of Breast Tomosynthesis in a Routine Screening Practice: An Observational Study,” was led by Dr. Stephen L. Rose, President and Founder of Rose Imaging, Medical Director of TOPS Comprehensive Breast Center, and Breast Radiologist affiliated with Memorial Hermann Health System in Houston, Texas, and published online in advance of print in the June 2013 issue of the American Journal of Roentgenology (AJR).

The analysis compared the outcomes of 2D mammography screening exams that were interpreted prior to the introduction of Hologic's 3D mammography, with screening exams after the introduction of 3D mammography into the practice.

The use of Hologic's 3D mammography resulted in:
   
 A significant 37% drop in recall ratesfrom 8.7% to 5.5%(p < 0.001)
 
 A 35% increase in cancer detection ratesfrom 4.0 to 5.4 per 1,000 screenings (p = 0.18)
 
 A 53% increase in invasive cancer detection ratesfrom 2.8 to 4.3 per 1,000 screening examinations (p = 0.07)
   
The study population included 13,856 women who had received conventional 2D mammography screening exams and 9,499 women who elected to receive a Hologic 3D mammography screening exam. The images were interpreted by one of six radiologists with an average 12 years of reading experience.

The Rose study is the first large U.S. breast cancer screening trial to report its results in a peer-reviewed journal. The findings are consistent with and supplementary to previously published studies including the Oslo Tomosynthesis Screening Trial (published inRadiology) and the Screening Tomosynthesis or Mammography (STORM) trial in Italy (published in The Lancet Oncology). All three studies confirm that adding Hologic 3D mammography technology to a 2D screening exam results in superior performance vs. 2D alone, as demonstrated by an increase in cancer detection rates coupled with a decrease in false-positive findings.



CR Mammography Found to Have Significant Limitations in Breast Cancer Screening 

In a study titled “Digital Compared with Screen-Film Mammography: Performance Measures in Concurrent Cohorts within an Organized Breast Screening Program” published May 14th online in advance of print inRadiology, Anna Chiarelli, PhD, and her colleagues from Cancer Care Ontario in Toronto found computed radiography (CR) mammography had significant limitations in detecting cancers compared to digital radiography (DR) and screen-film (SF) mammography. The researchers studied over 816,000 screening mammograms on women aged 50 to 74 enrolled in the Ontario, Canada breast screening program.

In what the authors said was the first study of its kind, the researchers found:
   
 Cancer detection rates for DR (4.9 per 1000 mammograms) and SF mammography (4.8 per 1000 mammograms) were similar. The cancer detection rate was significantly lower for CR (3.4 per 1000).
 
 Recall rates were higher for DR and lower for CR than for SF.
 
 Positive predictive value was lower for CR than for SF; however, the adjusted odds were not significant.
   
The researchers concluded that the cancer detection rate for CR mammography was significantly lower than DR or SF mammography and recommended that screening programs should monitor the performance of CR separately and may consider informing women of the potentially lower cancer detection rates.
The CR mammography study sparked uproar in Canada over whether to continue using computed radiography mammography scanners. Ontario Health Minister Deb Matthews, PhD, ordered that CR machines in the province be scrapped. Of Ontario's 316 mammography machines, 76 use CR technology, 188 use DR, and 52 use film.

Canada's other provinces use only a handful of CR machinesexcept for Quebec, where CR devices constitute 108 of 144 total mammography scanners. And Quebec plans to keep using them, even though mammography patients have been barraging their physicians' offices with questions and concerns.
  

Making the Business Case for Breast Tomosynthesis  

3D Mammography Technology Brings Patients to the Hospital Breast Center and to the Hospital as a Whole

Stamford Hospital, Connecticut

“We consider our investment in technology an investment in the health of the women we serve,” states David Sack, Director of Radiology at Stamford Hospital. “When I saw 3D mammography technology, I knew it made sense for our patients.”
Stamford Hospital
Katherine Hollister, Stamford's Lead Mammography Technologist, prepares a patient for a 3D mammogram.
The not-for-profit hospital was the second site in the state of Connecticut to add breast tomosynthesis technology, installing its first system a few months after the U.S. Food and Drug Administration approved the system. “Adding 3D mammography was the right thing for our patients,” Sack noted. “Plus, it fit our business plan and mission of building the best breast center in the region.”

When the first 3D mammography system was installed, the hospital found itself in a unique situation. The technology was only available at one of the hospital's two imaging locations, but patients wanted access to the technology at both. It quickly became clear women preferred the 3D mammogram; and, more women were coming and asking for it, which created scheduling issues.

So, in 2012, Stamford Hospital added two additional Hologic 3D mammography systems, and began offering the new technology to all screening patients. “The systems weren't budgeted, but it was the right thing to do,” explains Sack. “Our administration was convinced we were on the right path. They're very supportive of the Women's Breast Center.”

“The immeasurable impact of more women coming to the Breast Center is the downstream revenue,“ Sack notes. “There are more people in the system. Plus, women make the healthcare decisions in the family. If they're coming to Stamford Hospital because we have leading-edge technology, they're probably going to want to bring the rest of their family here for other medical care as well.”


3D Mammography Provides Earlier Detection, Draws New Patients to Breast Care Center

Methodist Hospitals, Merrillville, Indiana

The Breast Care Center on the Merrillville campus of Methodist Hospitals, a not-for-profit, community-based healthcare system, was specially designed to deliver high-quality, personalized care in a relaxed, comfortable setting easily accessible to women in the community. Word of the new facility and its reputation for excellence spread quickly and just a short time after opening, the Center was attracting women from throughout northwest Indiana and seeing as many as six new patients daily.
Methodist Hospitals
L to R: Dr. Anastasia Siatras, Radiologist; Dr. Kenneth Segel, Radiologist; Jennifer Sanders, Mammography Manager; and Stacy Knox, Certified Breast Care Nurse Navigator.
The cornerstone of the Breast Center's imaging services is breast tomosynthesis, which sets the benchmark for care in the region, and ensures the Breast Center will remain at the forefront of breast healthcare for many years to come. The hospital has three Hologic Selenia Dimensions 3D mammography systems and provides the technology at both campuses to ensure all patients receive 3D screening mammograms.

“We built our entire breast imaging concept around 3D imaging because we knew it was a landmark opportunity,” states Ian McFadden, President and CEO. “3D is one of the most innovative technologies we've seen in a long time and we were the first facility in Indiana, and one of the first fifty facilities in the country, to utilize this advanced breast imaging modality.”

Using 3D technology, the staff already is seeing an increase in the early detection of smaller invasive cancers and a reduction in recalls for additional views. “We added 3D imaging because it improves patient care,” adds Dr. B.H. Barai, Medical Director of Methodist Hospitals' Oncology Institute. “With 3D we can detect cancer earlier, which translates into a higher probability of cure.”

» Read more 

KLAS Women's Imaging Study on 2D mammography, ranks Hologic Selenia Dimensions 2D First
 
KLAS, a research firm specializing in monitoring and reporting on the performance of healthcare vendors, has published the second part of their two-part series on Women's Imaging Systems in use in the U.S. This is the third time that KLAS has looked at the Women's Imaging category, and the third time that a Hologic system has outperformed all other systems evaluated.

In the new report, the Selenia Dimensions outperformed all other 2D systems studied, earning a first place ranking on 19 of the 25 measures evaluated and a second place ranking on five of the six remaining measures.

Although the Hologic Selenia Dimensions 3D and Selenia systems were not fully evaluated in the new report, the author notes that the three Hologic systems ranked higher than any of the competitive mammography systems evaluated.

In a report published earlier this year, KLAS looked at the experiences of 50 Hologic tomosynthesis customers from 44 organizations that have been using the technology for at least 1 year. 90% said they are achieving a positive return on investment. ROI is not a result of traditional reimbursement or even patient fees—only 14 of the 44 customers surveyed said that they were charging.

Providers said tomosynthesis is indirectly building their bottom line because they are experiencing fewer false-positive call-backs and they are attracting more new patients. In fact, 89% who said they are getting a positive ROI said the technology has garnered new patients and referrals.

KLAS reports are available to healthcare providers at a significant discount. To purchase the reports visitwww.KLASresearch.com/KLASreports.



Want to learn more about breast tomosynthesis?
Contact Us


   Educational Opportunities


Hologic both offers and supports many comprehensive educational programs and events that provide clinicians the opportunity to learn the most up-to-date information on their own field and, when possible, gain hands-on experience on the most technologically-advanced tools available in women's health.
Hologic Live Technologist Training

Basics of Breast Tomosynthesis
July 13
Santa Clara, California 

Master DXA: Workshops to Improve Your Skills & Grow Your Practice

September 12
Bedford, Massachusetts

Basics of Breast Tomosynthesis
September 14
San Diego, California
Stereotactic Breast Biopsy: Prone & Upright Procedural Tracks
September 19
Bedford, Massachusetts

Positioning in Mammography Matters & Radiation Concerns
October 17
Bedford, Massachusetts

Understanding Breast Tomosynthesis
October 18
Bedford, Massachusetts
 
Hologic Supported Live Training**

Breast Imaging Boot Camp
July 30-August 1or
October 31-November 2
Reston, Virginia

Breast MR with Guided Biopsy
August 5-6
or
November 4-5
Reston, Virginia

Upcoming Webinars**

Real World Tomo: Case Studies in Digital Breast Tomosynthesis
June 20 
Hot Topics in Prostate MRI: Cancer Imaging & Biopsy ICPMEJuly 16
Archived Webinars**

Bone Densitometry - Hologic


Breast MRI CASE Series for Radiologists - ICPME

Breast Tomosynthesis - ICME

Prostate Webinar Case Review - ICPME

Stereotactic Breast Biopsy -ICPME

Ultrasound-Guided Breast Biopsy - ICPME
Tomosynthesis Webinar Clips on YouTube** 

Breast Tomosynthesis: Occult Radial Scar, ILC in Fatty Breast Tissue

Dr. Linda Greer
John C. Lincoln Breast Health and Research Center—Deer Valley Hospital, Phoenix, Arizona
» Watch video 

Breast Tomosynthesis: Fatty Replaced Breast

Dr. Stephen L. Rose
Houston Breast Imaging, Houston, Texas
» Watch video

Hologic Online Programs


Introduction to Breast Tomosynthesis Theory 
This 50-minute online program is geared towards radiographers who wish to learn about the theory and technology of breast tomosynthesis. 

DXA 101: The Basics of Bone Densitometry
This one-hour online program is geared towards technologists or operators and covers the theory and technology of bone densitometry.

Breast Tomosynthesis
This 40-minute Breast Tomosynthesis online webinar is presented by Dr. Martin Sonnenschein (Brustzentrum - Klinik Engeried, Bern, Switzerland).

Introduction to Breast Tomosynthesis and C-View 2D ImagingThis 20-minute online webinar is presented by Dr. Martin Sonnenschein (Brustzentrum - Klinik Engeried, Bern, Switzerland).
 

Hands-on Breast Tomosynthesis Seminars 

Seminars are given by a leading radiologist using this technology in a screening and diagnostic practice. Locations/dates subject to change.
 
June
21-22 — SOFMIS, Nice, France
22 — Toronto, Canada
26-27 — Senology Kongress, Munich, Germany

July
28 —Taipei, Taiwan
 The seminars range from 75-minute workshops to full-day training sessions. For more information, please contact your local Hologic representative or e-mailtomo.courses@hologic.com indicating the course date and location of interest.

Learn more about Hologic Medical Education offerings.
The views and opinions expressed herein are those of doctors and are not necessarily those of Hologic. This newsletter is intended for medical professionals and/or specific product users residing in the United States and other countries and should not be considered as a solicitation or promotion of any product or of an indication of any product that is not authorized by the laws and regulations of another country where the reader resides. This newsletter could refer to products that are or may not be available in any particular country, and/or may not have received market clearance by a governmental regulatory body for indications and restrictions in different countries.

* Hologic Inc. provides this coding guidance for informational purposes only. This guidance is not an affirmative instruction as to which CPT®/HCPCS codes and modifiers to use for a particular service, supply, procedure or treatment. It is the provider's responsibility to determine and submit the appropriate codes and modifiers for any service, supply, procedure or treatment rendered. Actual codes and/or modifiers used are at the sole discretion of the treating physician and/or facility. Contact your local carrier and payer organizations for specific coding guidelines. Hologic cannot guarantee medical benefit coverage or reimbursement with the codes listed in this guide. Any payment rates listed are Medicare averages that may be subject to change without notice. Reimbursement may differ based on geographic regional variance and/or policies and fee schedules outlined as terms in your health plan, payer and/or carrier contracts.

** Programs are supported by Hologic with an unrestricted educational grant.

Hologic, C-View, Dimensions, and Selenia are trademarks and/or registered trademarks of Hologic and/or its subsidiaries in the U.S. and/or other countries.

Παρασκευή, 17 Φεβρουαρίου 2012

H Ψηφιακή Τομοσύνθεση Σώζει ζωές

Από πολυκεντρικές μελέτες που πραγματοποιήθηκαν διερευνήθηκε η αποδοτικότητα του συστήματος της Ψηφιακής Τομοσύνθεσης Ηologic Selenia Dimensions 3D και συγκρίθηκε η ικανότητα του ακτινολόγου στην ανίχνευση του καρκίνου με χρήση της 2D ψηφιακής μαστογραφίας σε συνδυασμό με την 3D, συγκριτικά με την χρήση μόνο της κλασικής 2D ψηφιακής μαστογραφίας. Στην Εικόνα 6 φαίνεται η καμπύλη ROC (καμπύλη ευαισθησίας και ειδικότητας) η οποία προέκυψε κατά μέσο όρο από 12 ανεξάρτητες καμπύλες ROC. Η μέση περιοχή κάτω από την καμπύλη ROC αυξήθηκε για τους ιατρούς διαγνώστες από 0.83 σε 0.90 χρησιμοποιώντας μια καταγραφή  BIRADS , σημειώνοντας δηλαδή αύξηση της τάξεως του 0.07, μια ιδιαίτερα σημαντική αύξηση με p-value ίσο με 0.0004. Χρησιμοποιώντας την μέθοδο 2D+3D έναντι της 2D μόνο , βελτιώθηκε η ευαισθησία από 66% σε 76% στις περιπτώσεις καρκίνων  BIRADS 4 και 5. Η ειδικότητα (specificity) σε βλάβες κατηγορίας BIRADS 1-3,  αυξήθηκε από 84% σε 89%. Τέλος, παρατηρήθηκε μία μέση μείωση 43% του ποσοστού επανάκλησης (ψευδώς αρνητικά).
                   

Μόνο ο Ψηφιακός Μαστογράφος Hologic Dimensions 3D 

διαθέτει FDA approval για εξετάσεις ΤΟΜΟΣΥΝΘΕΣΗΣ


RSNA 2011 - Key Scientific Tomosynthesis Presentations

There were several key scientific tomosynthesis presentations given at RSNA 2011 that add to the growing body of support for the benefits of tomosynthesis.  Below are highlights of five of the most relevant presentations.  The RSNA abstract for each is provided in a separate, attached document.

1.            Reading Time of FFDM and Tomosynthesis in a Population-based Screening Program; Skaane P, Gullien R, Eben E, Ekseth U, Haakenaasen U, Jahr G Jebsen I, Krager M;
                RSNA 2011, MSVB31-07 Breast Series: Emerging Technologies in Breast Imaging
               
Overview:          
The Oslo Screening Study will enroll 20K – 25K patients and will be an important study in terms of worldwide clinical acceptance and adoption of tomosynthesis.  Interim results were based on enrollment of 3,356 patients in the first 3 months of the study.  

Key Results and Conclusions:    
·        47% increase in cancer detection using tomosynthesis plus 2D imaging (8 cancers were missed in the FFDM arm and none were missed in the tomosynthesis arm)
·        Interpretation time for tomosynthesis is acceptable for high-volume mode screening

2.            Tomosynthesis During Baseline Examinations: Preliminary Assessment from a Prospective Screening Trial
                Gur D, Sumkin J, Zuley M, Anello M, Catullo V, Chough D, Cohen C, Ganott M, Hakim C, Hoffman W, Shah R, Shinde D
                RSNA 2011, MSVB31-08 Breast Series: Emerging Technologies in Breast Imaging
               
                Overview:
                Analysis of first 120 patients in ongoing, prospective study to evaluate the use of tomosynthesis during baseline screening in subjects between 39 and 56 years of age.  This study will continue, with a projected enrollment of 2,000 subjects.
               
Key Results and Conclusions:
·        28% reduction in recall rate with the use of FFDM plus tomosynthesis compared to FFDM alone
·        The use of tomosynthesis plus FFDM results in a substantial decrease in recall rates during baseline screening mammography of young women

3.            FFDM vs FFDm with Tomosynthesis for Women with Radiographically Dense Breasts: An Enriched Retrospective Reader Study
                Rafferty E, Niklason L
                RSNA 2011, MSVB31-10 Breast Series: Emerging Technologies in Breast Imaging
               
                Overview:
293 cases with BI-RADS density score of 3 or 4 were read retrospectively by 8 radiologists to evaluate the performance of tomosynthesis in dense breasts.

Key Results and Conclusions:
·        10% increase in recall rate for cancer cases with tomosynthesis plus 2D compared to 2D alone
·        31% reduction in recall rate for non-cancer cases with tomosynthesis plus 2D compared to 2D alone
·        Significant gain in diagnostic accuracy (ROC performance) for tomosynthesis plus 2D compared to 2D alone
·        Signficant gain in diagnostic accuracy for non-calcification cases (masses and distortion) for tomosynthesis plus 2D compared to 2D alone
·        Significant gain in  diagnostic accuracy for calcifications for tomosynthesis plus 2D compared to 2D alone
·        The combination of FFDM plus tomosynthesis offers the potential for improved cancer detection and reduced recall rates in women with dense breasts

4.            Digital Breast Tomosynthesis vs Supplemental Diagnostic Mammography Images for the Evaluation of Noncalcified Breast Lesions
                Zuley M, Sumkin J, Ganott M, Bandos A, Kelly A, Lu A, Catullo V, Chough D, Gur D, Perrin R; RSNA 2011, MSVB31-06 Breast Series: Emerging Technologies in Breast Imaging

                Overview:
Retrospective review of diagnostic 2D and tomosynthesis images of 217 accrued lesions to compare diagnostic performance of tomosynthesis to additional diagnostic mammographic views

Key Results and Conclusions:
·        Tomosynthesis has comparable sensitivity and specificity to standard diagnostic additional mammographic views in non-calcified breast lesions
·        Tomosynthesis may be able to replace additional diagnostic mammographic images in the evaluation of patients suspected of having a non-calcified lesion

5.            A Two-fold Dose Reduction in Breast Screening with Tomosynthesis (DBT) through the Use of Reconstructed 2D Images from the DBT Dataset
                Gur D, Zuley M, Lu A, Anello M, Rathfon G, Abrams G, Hakim C, Wallace L, Chough D, Ganott M, Perrin R, Sumkin J
                RSNA 2011, MSVB31-09 Breast Series: Emerging Technologies in Breast Imaging

                Overview:
Retrospective reader study of 114 cases comparing the performance of synthetically reconstructed 2D with tomosynthesis to FFDM with tomosynthesis

                Key Results and Conclusions:
·        Moderately higher sensitivity with same sensitivity seen using true FFDM images compared to synthetically reconstructed 2D images, both combined with tomosynthesis
·        Minor improvement in quality of synthesized 2D images could lead to acceptable diagnostic quality (Note: an older reconstruction algorithm was used for these images; current version is expected to show greatly improved performance)

Hologic’s Selenia Awarded

Hologic’s Selenia Awarded

By Zacks Investment Research on  | More Posts By  | Zacks.com
In a major achievement, Hologic (NASDAQ:HOLX) won a gold Medical Design Excellence Award (MDEA) award for its Selenia Dimensions 2D/3D mammography system. MDEA, organized by the leading business-to-business media company UBM Canon, is a premier awards program that recognizes the achievements of medical devices manufacturers.
In the past, Hologic has received the gold MDEA award thrice – the Sentinelle Vanguard breast imaging and interventional coil in 2010, ThinPrep imaging system in 2004 and MammoSite radiation therapy system in 2003.
In February 2011, Hologic received approval from the US Food and Drug Administration (FDA) for its Selenia Dimensions three-dimensional (3D) digital mammography tomosynthesis system. Selenia has been developed on the Dimensions platform utilizing tomosynthesis technology to produce both 3D and the conventional two dimensional (2D) full field digital mammography (FFDM) images. The images can be used to screen and diagnose breast cancer. The product is already approved for providing 2D images. The Dimensions platform had received CE mark approval in Europe in fiscal 2008 and Canadian registration in March 2009, both for 2D and 3D modes of imaging.
Although a patient’s exposure to radiation would increase, the accuracy of detection of the disease is better with a combination of both 2-D and 3-D images. Following its approval, the product was immediately launched in the US. There are 12,000 mammography systems running in US consisting of 9,000 digital and 3,000 analog. Since approval, the company has upgraded a number of domestic systems and is pleased with the early uptake so far although adoption of the product will come about gradually. Consequently, a rapid ramp up in system sales is not expected this year.
Approval of the product will be of great help to the huge patient population. It is estimated that more than 40,000 women in America died from breast cancer in 2009. The stage at which the cancer is detected is significant as it is the right time to take medical recourse to increase woman’s survival.
With a wide range of products, Hologic has become an industry giant in the field of women’s health products. Although the Diagnostics segment has been suffering for the past few quarters due to lower doctor visits owing to economic uncertainty, the situation is gradually stabilizing. Moreover, the company is also undertaking several steps, including acquisitions, international expansion and product development to bolster its top line. 

Κυριακή, 31 Οκτωβρίου 2010

EUREF Certification


HOLOGIC DIGITAL MAMMOGRAPHY SYSTEM IS FIRST TO RECEIVE EUREF “MAMMOGRAPHIC TYPE TEST” CERTIFICATION

Certification ensures users that the Hologic Selenia system meets or exceeds rigorous European image quality and dose standards

BEDFORD, Mass. (June 22, 2010) /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 Hologic Selenia® digital mammography system with a tungsten tube has received “Mammographic Type Test” certification by the European Reference Organization (EUREF) Council for Quality Assured Breast Screening and Diagnostic Services. The Hologic system is the first mammography system of any type to receive this certification.
The mission of the non-profit EUREF council is to raise standards by bringing together at the EU level the best examples of quality control in mammography screening from regional and national breast cancer screening programs. EUREF mammographic type test certification ensures hospitals and imaging centers that Hologic’s Selenia systems have passed a rigorous series of physics and clinical tests demonstrating that the systems meet the image quality, radiation exposure, and stability standards set out by EUREF for screening and diagnostic mammography equipment.
“Our customers tell us they buy the Selenia system for a number of reasons. Two reasons show up on almost everyone’s list — exceptional image quality and low patient dose,” notes Peter Soltani, Senior Vice President of Breast Health at Hologic. ”The EUREF mammographic type test confirms what we’ve learned through our own clinical trials and scientific investigations — the Selenia system is optimal for use in mammography. With more than 6,000 systems installed, Selenia is the most popular digital mammography system in the world.”

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, visitwww.hologic.com.

Forward Looking Statement Disclaimer

This News Release may contain forward-looking information that involves risks and uncertainties, including statements about the use of the Selenia digital mammography 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 Selenia 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.
Hologic and Selenia are trademarks and/or registered trademarks of Hologic, Inc., and/or its subsidiaries in the United States and/or other countries.