U-Systems Hosts Second "Innovators in Breast Ultrasound Screening" Webcast Focusing on New Approaches to Breast Cancer Screening

SUNNYVALE, Calif., Oct 28, 2011 (BUSINESS WIRE) -- U-Systems, the leader in automated breast ultrasound (ABUS) technology, today announced another in their series of "Innovators in Breast Ultrasound Screening," webcasts, focusing on progressive approaches to breast cancer screening. The live interactive web-broadcast is scheduled for Tuesday, November 1st at 5pm PST (8pm EST). Registration information is available at www.BreastUltrasoundScreening.com .

The second module in a series of educational tools is intended for radiologists and other healthcare providers involved in the screening and management of patients with breast cancer, as well as technologists involved in the acquisition of images. The webinar will highlight how leading innovators in breast imaging are applying new 3D technology aimed at improving patient outcomes and expanding their clinical practice. The live course will be recorded and be available at www.BreastUltrasoundScreening.com after November 7th.

Educational content features guidance on risk based breast cancer screening, identifying women who would benefit from adjunctive breast screening and why; and review of the clinical data supporting the use of automated 3D ultrasound for women with dense breast tissue. Participants will be able to ask questions and discuss with these early adopters how they are increasing their detection rates of breast cancer in women with dense breasts.

source= Market Wire

Latest Clinical Evidence Supports Promising Outlook For Low-Dose Molecular Breast Imaging (MBI)

The possibility of low-dose Molecular Breast Imaging (MBI) looks promising according to the most recent clinical evidence revealed this past month at the National Institutes of Health (NIH). Dr. Marcela Bohm-Velez and her colleagues from Associates in Pittsburgh, Pa., shared preliminary results from a prospective study on low-dose MBI, specifically Breast-Specific Gamma Imaging (BSGI), at the SNM Breast Cancer Imaging: State of the Art 2011. Their results suggest it may be possible to reduce the radiation dose patients receive from a BSGI procedure by up to 60 percent.

The tracer used in this procedure, Technetium Tc99m Sestamibi (MIBI), has commonly been used in cardiac studies for years and was cleared by the FDA in the mid-1990s for diagnostic breast imaging. The recommended dose (20 - 30 mCi) was established using an older, larger, less sensitive whole body imaging system. Newer breast-optimized imaging systems have an inherently higher photon sensitivity that may allow a lesser dose to be used.

source: Dilon Diagnostics

Matakina and PenRad Sign Letter of Intent to Display Volpara™ Volumetric Breast Density Results on Mammography Review Station

For Use with Digital Mammography, Volpara is Designed to Assist Radiologists by Objectively and Automatically Assessing a Women's Breast Tissue Density

LAS VEGAS, March 15, 2011 /PRNewswire/ -- Matakina International, Limited of New Zealand and PenRad Technologies, Inc., a leader in medical image and information management, today announced that the companies have signed a Letter of Intent (LOI) to use the PenRad Mammography Information System (MIS) to display the Volpara™ breast imaging software. The announcement was made from the National Consortium of Breast Center's (NCBC) 21st Annual National Interdisciplinary Breast Center Conference.

Offering radiologists a reliable and cost-effective tool to automatically generate objective volumetric breast density values, the FDA-cleared Volpara breast imaging software computes volumetric breast tissue density from digital screening mammograms. Volpara software assists radiologists by providing objective, automatic and robust measurement of volumetric breast tissue density and is currently available for Hologic and GE digital mammography systems with validation of integration with other systems underway.

source: PR Newswire

New Technologies Open the Door for Low Dose Breast-Specific Gamma Imaging (BSGI) / Molecular Breast Imaging (MBI)

LAS VEGAS, March 17, 2011 /PRNewswire/ -- A new study by Craig Thiessen, M.D., Director of Radiology for West Houston Radiology L.L.P. and North Cypress Medical Center in Houston, presented this week at the National Consortium of Breast Centers Annual Meeting, found the improved photon sensitivity of new detector technologies such as PSPMTs and CZT should be capable of reducing the radiation dose patient receive from BSGI/MBI studies by 75%. However, low dose imaging is currently an off-label use of the radiopharmaceutical, and there are several prospective patient studies underway to validate the clinical feasibility of low dose imaging.

BSGI/MBI is a molecular imaging tool for detecting early stage breast cancer, particularly for women who are at increased risk for the disease or have dense breast tissue. BSGI/MBI utilizes a radiopharmaceutical to visualize metabolic activity, revealing highly active areas that may be indicative of disease. A primary benefit of BSGI/MBI is that the exam provides a physiological map complementary to the anatomical map produced by mammography, and its ability to detect cancer is not affected by dense breast tissue as mammograms often are. It is also especially useful when mammographic or ultrasonic imaging studies are normal or discordant in the presence of clinical signs and symptoms.

Dr. Thiessen, a nuclear medicine specialist and breast imager, said that "BSGI/MBI- as with PET imaging, shows that molecular imaging is more advantageous in conjunction with standard anatomical evaluation of the body, and specifically the breast. Mammography, ultrasound and MRI look at various structures and patterns, whereas BSGI/MBI looks at the breast on a cellular level to help determine the presence or absence of disease."

source: Dilon

For Use with Digital Mammography, Volpara is Designed to Assist Radiologists by Objectively and Automatically Assessing a Women's Breast Tissue Density

LAS VEGAS, March 15, 2011 /PRNewswire/ -- Matakina International, Limited of New Zealand and PenRad Technologies, Inc., a leader in medical image and information management, today announced that the companies have signed a Letter of Intent (LOI) to use the PenRad Mammography Information System (MIS) to display the Volpara™ breast imaging software. The announcement was made from the National Consortium of Breast Center's (NCBC) 21st Annual National Interdisciplinary Breast Center Conference.

Offering radiologists a reliable and cost-effective tool to automatically generate objective volumetric breast density values, the FDA-cleared Volpara breast imaging software computes volumetric breast tissue density from digital screening mammograms. Volpara software assists radiologists by providing objective, automatic and robust measurement of volumetric breast tissue density and is currently available for Hologic and GE digital mammography systems with validation of integration with other systems underway.

source: PR Newswire

Naviscan Announces European Launch of Positron Emission Mammography

VIENNA, March 2, 2011 /PRNewswire/ -- Naviscan, Inc., announces the European launch of the Naviscan Positron Emission Mammography (PEM) scanner at two prestigious radiology conferences in Vienna. On March 3rd, at the European Society of Breast Imaging (EUSOBI) Annual Scientific Meeting, a podium presentation will focus on recently published PEM (Positron Emission Mammography) data demonstrating PEM's ability to reduce unnecessary biopsies by providing superior specificity, the ability to differentiate between benign and malignant lesions. Simultaneously at the European Congress of Radiology (ECR) conference, March 3 - 7, a poster will be presented featuring new clinical data on the role of PEM for assessment of axillary lymph node (ALN) status in patients with breast cancer.

PEM scanners are high-resolution breast PET systems (also referred to as 3-D Molecular Breast Imagers or Tomographic MBI) that can show the location as well as the metabolic phase of a lesion. This information is critical in determining whether a lesion is malignant and influences the course of treatment. PEM scanners, which are about the size of an ultrasound system, are manufactured by Naviscan, Inc. and have been commercially available since 2007.

The poster will highlight new clinical data from researchers at the University of Chicago on the role of PEM for assessment of axillary lymph node status in patients with breast cancer. Current morphology-based tools for ALN staging include clinical examination, axillary ultrasound and breast MRI, but none are accurate enough to replace the need for pathologic evaluation of the axillary nodes.

source: Naviscan

SuperSonic Imagine Reports Validation of Clinical Benefits of ShearWave™ Elastography

March 5th, 2011 (Aix-en-Provence, France). SuperSonic Imagine presented yesterday the validation of a world wide multicentre study, based on European recruitment, confirming the benefit of ShearWave Elastography when added to ultrasound for improved lesion classification.

Launched by SuperSonic Imagine in June 2008, the global, multi-centre study was conducted across 16 American and European sites involving 1,800 patients with breast lesions. The first major result of this study demonstrated that ShearWave Elastography is reproducible both quantitatively and qualitatively.

This reproducible technology provides strong assurance of precise tissue evaluation during diagnosis and is expected to be also useful in follow-up.The second important outcome is a model based on 939 lesions, which showed that ShearWave Elastography increases the performance of ultrasound breast cancer diagnosis.The addition of ShearWave Elastography features, such as maximum elasticity (stiffness) or heterogeneity (uniformity) of a lesion, to B-mode ultrasound, would permit an improvement in the BI-RADS® classification accuracy, standardization tool for breast lesion classificationfrom the American College of Radiology) improving breast diagnosis.

source: Supersonic Imagine

Naviscan Announces European Launch of Positron Emission Mammography

European Launch Marked By Presentations of Significant New Clinical Data Demonstrating the Value of PEM in Improving Treatment Decisions for Breast Cancer

VIENNA, March 2, 2011 /PRNewswire/ -- Naviscan, Inc., announces the European launch of the Naviscan Positron Emission Mammography (PEM) scanner at two prestigious radiology conferences in Vienna. On March 3rd, at the European Society of Breast Imaging (EUSOBI) Annual Scientific Meeting, a podium presentation will focus on recently published PEM (Positron Emission Mammography) data demonstrating PEM's ability to reduce unnecessary biopsies by providing superior specificity, the ability to differentiate between benign and malignant lesions. Simultaneously at the European Congress of Radiology (ECR) conference, March 3 - 7, a poster will be presented featuring new clinical data on the role of PEM for assessment of axillary lymph node (ALN) status in patients with breast cancer.

PEM scanners are high-resolution breast PET systems (also referred to as 3-D Molecular Breast Imagers or Tomographic MBI) that can show the location as well as the metabolic phase of a lesion. This information is critical in determining whether a lesion is malignant and influences the course of treatment. PEM scanners, which are about the size of an ultrasound system, are manufactured by Naviscan, Inc. and have been commercially available since 2007.

source: Naviscan

Comprehensive Guide Offers Multiple Radiologic Modalities in Breast Imaging

(openPR) - New York/Stuttgart – Recently published by Thieme, Diagnosis of Breast Diseases: Integrating the Findings of Clinical Presentation, Mammography, and Ultrasoundoffers key information on the diagnosis of breast diseases using the clinical examination and various radiological modalities. With more than 1,500 radiographs, ultrasound images, and mammograms, this lavishly illustrated atlas offers pre-operative considerations as well as peri- and post-operative management advice.

“[This book is] focused mainly on difficult cases illustrating the diagnostic hurdles and forensic pitfalls that are encountered in breast diagnosis.” says Dr. Volker Barth, MD, Institute for Breast Diagnosis, Esslingen, Germany.

This highly visual guide offers thorough evaluation of the various methods for early detection and accurate diagnosis, including analog and digital mammography, ultrasound, MR imaging, PET/CT, and interventional procedures – all within the setting of the clinical situation. The authors discuss advantages and drawbacks of each procedure in different scenarios. Additionally, this concise resource contains special sections on breast cancer in men and young women, and a discussion of women who are pregnant or lactating,

source: Open PR

TechniScan signs agreement with Texas-based company to co-develop a new version of its breast imaging device

SALT LAKE CITY (January 18, 2011) – TechniScan (OTCBB: TSNI), a medical device company engaged in the development and commercialization of an automated 3D breast ultrasound imaging system, announced today that it has signed a Product Development Agreement with Austin, Texas based Womens3D, Inc. worth a minimum of $1.5 million.

TechniScan and Womens3D will co-develop technology specifically for Womens3D’s proposed target market that is directed toward women’s health practices.

Under the terms of the agreement, Womens3D acquired a prototype of the TechniScan WBU system for $250,000 and contemplates contributing at least $1.25 million more to support development of a specialized whole breast ultrasound imaging system based on the TechniScan Warm Bath Ultrasound (WBU) product now in clinical testing. In addition, TechniScan will supply technical support of the product and customization of the imaging network applications that will be used in part to store and transmit the image files.

source: Techniscan Medical Ssytems

Breast cancer screening with MRI benefits women with radiation therapy history

OAK BROOK, Ill. – Breast cancer screening with MRI can detect invasive cancers missed on mammography in women who've undergone chest irradiation for other diseases, according to a new study published online and in the April print edition of Radiology.

Women who receive radiation therapy as children and young adults for diseases like Hodgkin's lymphoma face a significantly greater risk of breast cancer later in life. The incidence of breast cancer increases approximately eight years after chest irradiation, and 13 percent to 20 percent of women treated with moderate- to high-dose chest irradiation for a pediatric cancer will be diagnosed with breast cancer by age 40 to 45. In comparison, the cumulative incidence of invasive breast cancer by age 45 among women in the general population is only 1 percent.

"MRI's efficacy as an adjunct to mammography in screening women at high risk because of genetic mutation or family history has been established," said the study's lead author Janice S. Sung, M.D., radiologist at Memorial Sloan-Kettering Cancer Center (MSKCC) in New York City. "However, there were no reports in the literature about utility of MRI screening in women who are at high risk specifically due to prior chest irradiation."

In the study, Dr. Sung and colleagues reviewed screening breast MRIs performed at MSKCC between January 1999 and December 2008 on women with a history of chest irradiation. They looked at data from 247 screening breast MRIs in 91 women, with a focus on the number of cancers diagnosed, the method of detection and the tumor characteristics.

Of the 10 cancers found during the study period, four were detected with MRI alone, three with MRI and mammography, and three with mammography alone. The four cancers detected with MRI alone were invasive, while the three cancers detected with mammography alone were in their early stages.

source: EurekAlert

Siemens Celebrates First US Installation of MAMMOMAT Inspiration Full-Field Digital Mammography System

Malvern, Pa., February 15, 2011 – Siemens introduces its next generation of digital mammography with the first US installation of its MAMMOMAT® Inspiration at one of Zwanger-Pesiri Radiology’s nine locations on Long Island, New York. The Inspiration offers digital screening and diagnostic mammography, stereotactic biopsy, and upgrade capability to future technologies all in one system.

“The installation of the MAMMOMAT Inspiration is a key differentiator in helping us provide our patients the most comfortable mammography experience while capturing high quality clinical images,” explained Steven Mendelsohn, M.D., medical director for Zwanger-Pesiri Radiology. “Even though most people understand the importance of having a mammogram, it is not often considered a pleasant experience and many women put off having the exam. The Inspiration’s unique design and comfort features can help patients in our community feel less intimidated by the exam and could be a driver in helping to encourage them to schedule regular mammograms, which is critical to early breast cancer detection."

source: Siemens Medical

Hologic Receives FDA Approval for First 3-D Digital Mammography (Breast Tomosynthesis) System

BEDFORD, Mass., Feb. 11, 2011 /PRNewswire/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, today announced the Company received approval from the U.S. Food and Drug Administration (FDA) for its Selenia Dimensions digital breast tomosynthesis system (Dimensions 3-D).

Mammography systems using conventional 2-D imaging have limitations caused by tissue overlapping tissue in the breast that may hide lesions or cause benign areas to appear suspicious. Clinical trials using Hologic's Dimensions 3-D system showed measurable improvement in clinical performance over conventional mammography. These trials also showed significant gains in specificity — the confidence to rule out cancer without recalling the patient for further study — and other benefits including improved lesion and margin visibility and the ability to accurately localize structures in the breast. The combination of measurable improvements in accuracy and detection, and improved sensitivity, makes the Dimensions 3-D system a superior system vs. conventional digital mammography systems.

source: Hologic

Hologic Targets Women's Health Professionals at ECR 2011

BEDFORD, Mass., Feb. 8, 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, will focus on new, ready to market technologies in women's imaging at the European Congress of Radiology (ECR), the annual meeting of the European Society of Radiology in Vienna, Austria, March 4-7.

Hologic will be one of the largest exhibitors at ECR 2011. Over 19,000 participants from more than 100 countries are expected to attend.

A major feature of the Hologic exhibit this year is 3D mammography (breast tomosynthesis) and the Hologic Selenia Dimensions 3D breast tomosynthesis option. Selenia Dimensions, the newest imaging platform in the world's most popular digital mammography line, directly addresses the primary limitations of 2D mammography – the superimposition of normal breast tissue.

Selenia Dimensions systems are installed in more than a dozen countries and cleared for sale in 40 countries. Selenia Dimensions delivers the exceptional 2D images the industry has come to expect from Hologic and, for the first time ever, gives radiologists the option of offering their patients a conventional 2D digital mammogram and a 3D tomosynthesis exam – all under one compression, in just seconds.

source: Hologic

Siemens to Give Away a MAMMOMAT Inspiration in “Who Inspires You?” Video Contest

Malvern, Pa., Jan. 6, 2011– In celebration of the launch of the MAMMOMAT® Inspiration, Siemens new full-field digital mammography system, the company announces the “Who Inspires You?” contest. The winning hospital or imaging center will receive a brand new MAMMOMAT Inspiration and five runners-up will receive a $10,000 voucher toward the purchase of a new Inspiration.

“Siemens conducted customer workshops around the world, in which they gave us their vision for a new mammography system. We listened to them and the MAMMOMAT Inspiration is a direct result of that customer feedback. They inspired us…now we want to know who inspires them. That is what this contest is about,” explained Gerhard Schmiedel, vice president, X-ray Products, Siemens Healthcare.

By going to www.whoinspiresyoucontest.com, healthcare facilities can submit brief videos nominating up to three clinical staff members that regularly inspire colleagues and/or patients in the battle against breast cancer. Candidates can include breast surgeons, oncologists, radiology technologists, radiologists, breast care patient coordinators, OB-GYNs or any other healthcare professional who goes above and beyond his or her responsibilities to provide exceptional patient care in the area of breast cancer.

source: Siemens Medical

Preoperative Breast MRI Suggests High Cancer Yield and Positive Predictive Value in Newly Diagnosed Patients, Study Finds

The use of preoperative Breast MRI detects otherwise occult cancer with a relatively high degree of accuracy when applied to a diverse population of patients newly diagnosed with breast cancer, according to a study in the January issue of the American Journal of Roentgenology.

The study was performed at the University of Washington and Seattle Cancer Care Alliance in Seattle, WA. The review initiated with 592 patients who were recently diagnosed with breast cancer and underwent staging with preoperative breast MRI. The analysis set was comprised of 570 patients, whose biopsy rates, positive predictive values (PPVs) of biopsy, and overall cancer yields were calculated and compared using the chi-square test across patient age, breast density, index tumor type, receptor status and lymph node status.

“Our data add to the growing body of literature that documents breast MRI's ability to detect otherwise occult additional disease in patients who have been newly diagnosed with breast cancer,” said Robert Gutierrez, MD, lead author of the study.

“We found that use of preoperative breast MRI in newly diagnosed cancer patients resulted in an added cancer yield of 12%.This is much higher than the added cancer yield of .08 to 6.7% seen with high risk screening breast MRI, a more widely accepted indication for breast MRI,” said Gutierrez.


source: ARRS

Carestream Health Announces FDA Approval Of Advanced Software, Screens For Its CR Mammography System

ROCHESTER, N.Y., Dec. 9 — Carestream Health announced the U.S. Food and Drug Administration (FDA) has approved a Premarket Approval (PMA) supplement for enhanced screens and image processing software for its CR mammography system.

Carestream Health’s EHR-M3 screens are its third generation of screens designed specifically for mammography. The system has higher DQE (detective quantum efficiency) with the new screens, which were designed to enhance the quality of the acquired images. The latest approval also covers the application of Carestream Health’s advanced image processing algorithm that was designed to enhance the overall displayed quality of mammography images.

These features were released in other markets around the world earlier this year, and the latest approvals allow these advanced features to be immediately implemented in clinics, breast imaging centers and hospitals in the United States.

source: Carestream Health

Advances in Breast Imaging Improve Patient Care, Aid in Earlier Cancer Detection

OREM, UT, December 16, 2010 /24-7PressRelease/ -- The new KLAS "Breast Imaging 2010: A More Complete Picture" report takes an all-inclusive look at breast imaging technologies from a patient perspective, beginning with digital mammography and moving through CAD, MIS and ending with a discussion of newer breast-specific imaging technologies. Providers were noticeably energized about breast-specific imaging units such as the Dilon 6800 Gamma Camera and U-Systems somo-v INSIGHT whole breast ultrasound. However, because reimbursements vary, ROI occasionally takes a hit.

"Providers are looking for more patient-friendly imaging options and the U-Systems ultrasound fits the bill because it's a non-invasive, no-dose exam. Some physicians we spoke with mention that whole breast ultrasound would be a great screening tool, but currently most providers cannot get reimbursed for screening with the ultrasound," said Emily Crane, co-author of the report. "Digital mammography is still more cost effective for providers--and currently the only approved screening tool."

The wider adoption of CAD and MIS systems has also helped to increase ROI for digital mammography. Providers report that both systems increase the efficiency and workflow for breast imaging.

source: 24-7 Press release

Novel Imaging Technique May Reduce Lymphedema in Breast Cancer Patients

SAN ANTONIO — With guidance from a specialized scan, radiation oncologists at Mayo Clinic were able to reduce by 55 percent the number of lymph nodes critical for removing fluid from the arm that received damaging radiation doses.

The researchers report that integrating single photon emission computed tomography(SPECT) with the computerized tomography(CT) scans utilized for breast cancer radiotherapy planning may offer patients substantial protection against lymphedema, an incurable, chronic swelling of tissue that results from damage to lymph nodes sustained during breast cancer radiation. The SPECT-CT scan pinpoints the precise locations of the lymph nodes that are critical for removing fluid from the arm, allowing physicians to block them, as much as possible, from X-ray beams delivered to the chest.

These findings were presented at the 33rd Annual CTRC-AACR San Antonio Breast Cancer Symposium.

source: Mayo Clinic

Toshiba Enhances Aplio XG with Women’s Imaging Configuration Designed to Improve Breast and High-Risk OB/GYN Imaging

CHICAGO, Dec. 1, 2010 – Many healthcare providers use ultrasound as a first-line diagnostic tool in detecting and monitoring women’s health conditions. To help meet the needs of healthcare providers administering women’s imaging, Toshiba has introduced a women’s imaging configuration for the AplioTM XG at this year’s Radiological Society of North America (RSNA) annual meeting in Chicago, Nov. 28 – Dec. 3, 2010 (Booth #3435, South Hall). Aplio XG’s women’s imaging configuration is designed to support a range of women’s imaging needs, from everyday breast imaging to high-risk OB/GYN/perinatology, ultrasound-guided biopsies and fetal exams.

“Toshiba developed the Aplio XG women’s imaging configuration to make exams faster, safer and more accurate,” said Tomohiro Hasegawa, director, Ultrasound Business Unit, Toshiba. “This dedicated women’s imaging system can address a range of clinical conditions, making it a multi-functional tool for today’s demanding ultrasound environment.”

The Aplio XG women’s imaging configuration includes Elastography, MicroPureTM, Dynamic Micro Slice matrix transducer and 4D improvements.

source: Toshiba Medical

U-Systems Introduces Significant Upgrades to 3D Automated Breast Ultrasound Workstation at RSNA

CHICAGO, Nov 29, 2010 (BUSINESS WIRE) -- U-Systems, Inc., the leader in automated breast ultrasound, announced significant upgrades for its somo*v(R) Automated Breast Ultrasound System (ABUS) at the 96th Annual Meeting of the Radiology Society of North America, November 28 -- December 3. Featuring software improvements and hardware-accelerated programming, Release One*5 and SomoSTORAGE(TM) Departmental Storage Solution upgrades are designed to enable faster access to patient images and help radiologists simplify reading protocols for higher productivity.

Release One*5 is the latest update to U-Systems somo*VIEWer(TM) Advanced ABUS Workstation. It supports import/export of all DICOM images and Compare View allows side-by-side comparison of same-patient serial exams. Active-Motion Transition maintains view acuity during layout transitions for reduced read times. Release One*5 also establishes a bi-directional e-link to Hologic SecurView(TM) diagnostic workstations, allowing corresponding mammography and ABUS cases to be opened simultaneously.

U-Systems also announced the introduction of SomoSTORAGE(TM) Departmental Storage Solution, designed to store multimodality breast images, including large-volume 3D ultrasound data files. SomoSTORAGE delivers a new way to view data storage directories, transforming ordinary, text-based file names into graphic-based image galleries for rapid visualization of the file content. This offers additional value for quick consolidation of teaching cases and training databases.

source: Business Wire

Hologic Receives FDA Approvable Letter For Selenia Dimensions (3-D) Digital Mammography Tomosynthesis System

BEDFORD, Mass., (November 23, 2010) - 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 Hologic has received an approvable letter from the U.S. Food and Drug Administration (FDA) for the Selenia Dimensions three-dimensional (3-D) digital mammography tomosynthesis system. Final approval of the Company's pre-market approval application for the system remains subject to satisfactory review and inspection of our manufacturing facility, methods and controls. The Company plans to work closely with the FDA to complete this final inspection.

"We are extremely pleased to have received the FDA's approvable letter, which represents an important step forward in the commercialization of our Selenia Dimensions tomosynthesis system," said Rob Cascella, President and Chief Executive Officer. "The Selenia Dimensions technology is designed to provide radiologists with enhanced screening and diagnostic capabilities through the incorporation of fast, high-quality 3-D imaging in combination with 2-D imaging. We believe this new technology will address many of the limitations present in stand-alone 2-D imaging and improve upon both sensitivity and specificity. We look forward to working with the FDA to complete the remaining steps in the approval process."

source: Hologic

Siemens MAMMOMAT Inspiration Digital Mammography Commercially Available in U.S.

Malvern, Pa., November 17, 2010 – Siemens announces that the MAMMOMAT® Inspiration Full-Field Digital Mammography System is now commercially available in the United States. The MAMMOMAT Inspiration offers digital screening and diagnostic mammography, stereotactic biopsy, and upgrade capability to future technologies all in one system.

Siemens conducted customer workshops around the world, in which radiologists, radiology technologists and physicists contributed details and suggestions on their vision for a next generation digital mammography system.

“The MAMMOMAT Inspiration is a direct result of that customer feedback so it was truly inspired by them,” said Gerhard Schmiedel, vice president, X-ray Products, Siemens Healthcare. “The system was designed to help provide a more pleasant examination environment for patients, more efficient workflow for technologists, and excellent image quality for physicians.”

source: Siemens Medical

Radiology Journal Publishes Data That PEM Scanners May Reduce Unnecessary Breast Biopsies And Offer An Alternative For Women Who Cannot Tolerate MRI

The Radiology journal released new data from an NIH-sponsored, multi-site study of hundreds of women with newly diagnosed breast cancer that shows Positron Emission Mammography (PEM) may reduce unnecessary breast biopsies. The study found that PEM was significantly more precise at identifying benign and cancerous lesions, in what scientists call "Positive Predictive Value" or "PPV," therefore reducing the number of unnecessary biopsies. A common physician complaint regarding the use of Breast MRI is its tendency to identify suspicious lesions, requiring biopsies, which ultimately are found to be benign.

This finding is a welcomed outcome for women and physicians looking for ways to reduce the patient trauma associated with biopsies and for payors looking to reduce the costs associated with unnecessary procedures. The 388 woman study showed that PEM not only demonstrated a six percent improvement in specificity at comparably high sensitivity, but that PEM also had 31 fewer unnecessary biopsies and 26% higher PPV than Breast MR.

source: Naviscan

FDA Reclassifies Certain Digital Mammography Devices

The U.S. Food and Drug Administration announced that it is easing the pathway to market for mammography systems that produce computerized X-ray images of the entire breast.

These systems, known as Full Field Digital Mammography Systems, are an alternative to mammography systems that produce X-ray film.

When first approved by FDA in 2000, digital mammography systems were categorized as a high risk or Class III device, because they were then considered novel systems for screening and diagnosing breast cancer.

Since then, digital mammography has been well-validated in scientific studies involving tens of thousands of patients. The benefits and risks of digital versus film mammography have also been well -described to physicians. As a result, the FDA has decided to reclassify digital mammography from Class III devices to Class II or medium risk devices.

source: Medical News Today