12.20.2010

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

12.18.2010

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

12.13.2010

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

12.04.2010

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

11.29.2010

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

11.26.2010

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

11.19.2010

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

11.17.2010

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

11.05.2010

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

10.15.2010

Study Determines Breast-Specific Gamma Imaging Is More Effective Than Ultrasound in Patients With Complex Breast Tissue

WASHINGTON, Oct. 6 /PRNewswire/ -- Results of a study on Breast-Specific Gamma Imaging (BSGI) presented at the annual breast meeting of the American Society of Clinical Oncology in Washington, D.C., showed that BSGI was nearly twice as effective in finding cancers and more than three times as likely to lead to the correct diagnosis when compared to ultrasound.

Breast-specific gamma imaging (BSGI) is a molecular breast imaging technique being used more frequently as a diagnostic tool in breast centers across the nation. BSGI complements the anatomical imaging of mammography and is performed using an injection of the radiopharmaceutical Sestamibi, an imaging agent that when paired with breast-optimized gamma cameras helps determine the function of breast tissue.

A dedicated breast surgeon in Philadelphia, Dr. Ann Rosenberg, was the lead author on the retrospective, multicenter study. Rosenberg and her group compared the results of BSGI and ultrasound in patients who had dense breast tissue and a remaining diagnostic concern after mammography. The study was performed using a Dilon 6800 Gamma Camera with the standard recommend dose of approximately 20 millicuries of Sestamibi. The results show that BSGI was nearly twice as effective in finding cancers and more than three times as likely to lead to the correct diagnosis when compared to ultrasound.

source: PR newswire

8.30.2010

Preliminary Research Results Suggest Up To 70% Reduction In Dose For Positron Emission Mammography Imaging

In a recent study presented at the American Association of Physicists in Medicine (AAPM) 52nd Annual Meeting, researchers at the University of Washington showed that 18FDG dose for Positron Emission Mammography (PEM) may be reduced by as much as 70% without altering image quality.

PEM scanners are high-resolution breast PET systems that show the location as well as the metabolic phase of a lesion. The metabolic view assists physicians to make the optimal cancer care decision by providing an unprecedented ability to distinguish between benign and malignant lesions, what researchers term "specificity." PEM is different than x-ray mammography in that it is currently not used as a screening modality, rather is deployed to confirm extent of disease in a patient already diagnosed with a primary breast cancer.

"We have several tools to help us make better patient care choices. Mammography is our primary screening tool. PEM is used in women with known breast cancer in order to plan treatment," said Wendie Berg, MD, Breast Imaging Radiologist, Lutherville, MD. "Radiation for treatment of breast cancer uses doses which are roughly 5000 times higher than a diagnostic PEM study. Minimizing radiation dose is still important for any patient, and we can likely cut the dose of PEM in half, but the benefit to proper treatment exceeds the still low risk from the radiation dose of PEM."

Naviscan

8.05.2010

Hologic Completes Acquisition of Sentinelle Medical

BEDFORD, Mass., Aug 05, 2010 /PRNewswire via COMTEX/ -- Hologic, Inc. (Hologic or the Company) /quotes/comstock/15*!holx/quotes/nls/holx (HOLX 15.90, -0.16, -0.10%) , a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today the completion of its acquisition of Sentinelle Medical Inc. (Sentinelle Medical), a leading provider of Magnetic Resonance Imaging (MRI) breast coils, tables and visualization software.

"We are extremely pleased we have finalized the acquisition of Sentinelle Medical," said Rob Cascella, President and Chief Executive Officer. "We believe MRI will be an important standard of care for breast screening of women indicated as having a high risk of developing the disease. Adding Sentinelle Medical's products to Hologic's best-in-class portfolio of product offerings in the areas of breast cancer detection and intervention will enhance our Company's presence as a leader in women's healthcare."

Sentinelle Medical, a privately-held medical imaging company headquartered in Toronto, Canada, is dedicated to developing advanced breast imaging technologies using high-field strength MRI that will help in the earlier detection and better treatment of breast cancer.

source: MarketWatch

7.07.2010

Hologic to Acquire Sentinelle Medical

BEDFORD, Mass., July 6 /PRNewswire-FirstCall/ -- Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced today that it has entered into a definitive agreement to acquire Sentinelle Medical Inc. (Sentinelle Medical), a leading provider of Magnetic Resonance Imaging (MRI) breast coils, tables and visualization software.

The purchase price for the transaction will be $85 million, plus a two-year contingent earn out. The earn out will be payable in cash installments equal to a multiple of the incremental revenue growth in Sentinelle Medical's business in the two years following the closing. This transaction is expected to close during the third calendar quarter and is subject to customary closing conditions, including, among others, Sentinelle Medical stockholder approval and Canadian judicial approval.

Sentinelle Medical, a privately-held medical imaging company headquartered in Toronto, Canada, is dedicated to developing advanced breast imaging technologies using high-field strength MRI that will help in the earlier detection and better treatment of breast cancer.

"The agreement to acquire Sentinelle Medical is a further example of our strategy to maintain a leadership position in women's healthcare," said Rob Cascella, President and Chief Executive Officer. "Magnetic Resonance (MR) is rapidly becoming a standard of care for breast cancer screening of women indicated as having a high risk of developing the disease. This acquisition should further strengthen our comprehensive portfolio of product offerings in the areas of breast cancer detection and intervention."

source: PR Newswire

6.17.2010

TechniScan announces adding another center to worldwide clinical trials for new breast imaging system

SALT LAKE CITY (June 16, 2010) – TechniScan, (OTC BB: TSNI) a medical device company engaged in the development and commercialization of an automated 3D breast ultrasound imaging system, today announced that it has launched a clinical study in Rochester, Minn., its third new clinical site to commence in the last five months.

TechniScan’s Warm Bath Ultrasound (WBU) system is designed to capture three-dimensional images of the breast as a woman lies prone on a table and state-of-the-art ultrasound technology is used in a warm water tank to image the breast anatomy. Its revolutionary new method of imaging produces information and whole breast images that are not available with traditional reflection ultrasound or whole breast ultrasound systems presently on the market.

To date, TechniScan has scanned over 800 women in clinical studies in Salt Lake City and Ogden, Utah as well as Orange and San Diego, California. These past clinical studies focused on key factors like image quality, repeatability, and establishing protocols for testing baseline values for positive and negative predictive capabilities of the system.

source: Techniscan

6.07.2010

GE Healthcare Collaborates on Investigational Molecular Breast Imaging System for Early Breast Cancer Detection

GE Healthcare, a unit of General Electric Company (NYSE: GE), announced its collaboration in two clinical trials with the Tel Aviv Sourasky Medical Center in Tel Aviv, Israel and Hamilton Health Sciences Hospital in Ontario, Canada on the use of a novel technology that may assist in assessment and early detection of breast cancer in women who are at high risk for the disease.

GE Healthcare’s investigational Molecular Breast Imaging (MBI) system is a gamma camera dedicated for breast imaging based on accumulation of a radioactive tracer in hypermetabolic cancer cells. The innovation of the MBI technology is the use of imaging detectors, Cadmium Zinc Telluride (CZT), to replace the standard NaI detectors routinely used for gamma cameras, in a dedicated breast device. Extensive early clinical work done in the Mayo Clinic in the U.S. shows encouraging results with the use of MBI technology.

In these two prospective studies, the diagnostic accuracy of MBI will be determined in patients at high risk for breast cancer, including patients with dense breast tissue in whom conventional modalities used for breast, X-ray mammography and ultrasonography, are suboptimal.

“Breast cancer is a foremost health problem for women worldwide and it is growing in numbers,” said Nathan Hermony, GE Healthcare Nuclear Medicine global manager. “Early detection is critical for improving breast cancer survival rates. This technology is intended to improve early detection in women who are at high risk for developing breast cancer, or in women with dense breasts who are less likely to benefit from conventional mammography.”

source: Newswire Today

6.01.2010

GE Healthcare Unveils Innovative Technology in Breast Cancer Imaging; Can Reduce Time from Detection to Diagnosis

PARIS, Jun 01, 2010 (BUSINESS WIRE) -- GE Healthcare /quotes/comstock/13*!ge/quotes/nls/ge (GE 16.32, -0.03, -0.18%) , a pioneer in digital mammography, today announced the introduction of an innovative technology to aid in breast cancer diagnosis. GE Healthcare's new SenoBright(1) Contrast Enhanced Spectral Mammography (CESM) technology reduces ambiguity in mammography results, enabling physicians to detect and diagnose cancer with more confidence - even in the densest part of the breast tissue more rapidly and accurately.

Working like the multiple-flash, red-eye reduction function in a digital camera, SenoBright uses X-rays at multiple energies to create two separate exposures. These resulting images specifically illuminate and highlight areas where there is angiogenesis, growth of small blood vessels potentially related to the presence of cancer.

"A CESM exam takes from 5 to 10 minutes," said Dr. Clarisse Dromain, Gustave Roussy Cancer Institute, France. "During my investigation of the use of CESM with my own examinations of patients, I have been able to better define the spread of a cancer compared to standard mammography and ultrasound, and follow-up exams with an MRI (Magnetic Resonance Imaging) validated exactly the same results. Moreover, in the majority of cases the confidence in the diagnosis is high enough that the patient can be told the results that same day," she added.

source: MarketWatch

5.23.2010

Patent Awarded to the Design of TechniScan's Unique 3-D Breast Imaging System

SALT LAKE CITY, May 13 /PRNewswire-FirstCall/ -- A newly awarded U.S. Patent will protect TechniScan, Inc's., (OTC Bulletin Board: TSNI) novel way to image, biopsy and treat breast cancer.

U.S. Patent 7,699,783 B2 titled "Method for Imaging and Treating a Breast" covers the company's design of a 3-D, Warm Bath Ultrasound™ system that images while a woman lies prone on a table with her breast comfortably immersed in a warm water, state-of-the art scanning system.

Since she is lying on a table with her breast through an opening, the breast is in a pendant, uncompressed position that allows for a true three-dimensional image to be constructed.

"Imaging of the non-compressed pendant breast, similar to positioning for breast MRI, provides reproducible, 3-D anatomically accurate detail," said Yuri Parisky, M.D., medical imaging director at Mammoth Hospital in Calif. "It is the ideal position to image the breast."

A vital element of the new patent is the table design of the Warm Bath Ultrasound™ (WBU™) system, which rises above the water bath tank after the scan. This functionality has three key benefits: The woman remains on the same table for diagnostics and treatment, it maintains the known position of the tumor or lesion and allows the three-dimensional image to be utilized to guide treatment instruments.

source: PR Newswire

5.17.2010

New Concerns About Radiation And Breast Cancer

It is well established that exposure to ionizing radiation can result in mutations or other genetic damage that cause cells to turn cancerous. Now a new study led by researchers with the U.S. Department of Energy's Lawrence Berkeley National Laboratory (Berkeley Lab) has revealed another way in which radiation can promote cancer development. Working with cultures of human breast cells, the researchers discovered that radiation exposure can alter the environment surrounding the cells so that future cells are more likely to become cancerous.

"Our work shows that radiation can change the microenvironment of breast cells, and this in turn can allow the growth of abnormal cells with a long-lived phenotype that has a much greater potential to be cancerous," says Paul Yaswen, a cell biologist and breast cancer research specialist with Berkeley Lab's Life Sciences Division.

source: Medical News Today

5.03.2010

Breast MRI Could Reduce Local Breast Cancer Recurrence Rates, Study Suggests

The use of preoperative breast magnetic resonance imaging (MRI) prior to surgical intervention (for the treatment of breast cancer) can reduce the number of local (confined to the breast) cancer recurrences at follow-up, according to a study to be presented at the ARRS 2010 Annual Meeting in San Diego, CA. MRI of the breast is a noninvasive medical test that helps physicians diagnose and treat breast cancer.

“Local and regional recurrences after breast-conserving surgery are rare events,” said Valeria Dominelli, MD, lead author of the study. “However young age and breast density put patients at a greater risk,” said Dominelli.

The study, performed at the University of Rome “La Sapienza” in Rome, Italy, included 49 patients with a local recurrence that was detected after surgical treatment of the primary carcinoma. Ten patients had a contrast-enhanced MRI prior to surgery while the remaining 39 patients did not. Contralateral carcinoma (cancer in the opposite breast) and local recurrence were seen significantly more in patients who did not receive an MRI examination prior to surgery.

“Our study suggests that preoperative breast MRI staging allows for a significant reduction in the number of local cancer recurrences at follow-up,” said Dominelli.

source: ARRS

5.02.2010

BSGI Offers Clear View of Breast Tumor Response to Neoadjuvant Chemotherapy

NEWPORT NEWS, Va., April 30 /PRNewswire/ -- A new study, presented at the American Society of Breast Surgeons Annual Meeting in Las Vegas, found that Breast-Specific Gamma Imaging (BSGI) is highly accurate in monitoring the response of breast cancers to neoadjuvant chemotherapy.

BSGI, a molecular breast imaging technique (MBI), has been proven in several other studies to improve breast cancer detection and aid in the management of patients with difficult to diagnose breast tissue.

The study, conducted by Dr. Christine Teal, Chief of Breast Surgery at The George Washington University Hospital in Washington, D.C., and her team of researchers, found that BSGI accurately monitors tumor response to neoadjuvant chemotherapy.

According to Dr. Teal, "BSGI provides excellent specificity and sensitivity in determining initial tumor size as well as accurately reflects response to neoadjuvant chemotherapy. This allows for more precise surgical planning prior to definitive surgical procedure in this population of women."

source: PR Newswire

4.23.2010

Manhattan Scientifics' Technology Able to Detect Breast Cancer Three Years Earlier Than Mammogram

ALBUQUERQUE, N.M.--(BUSINESS WIRE)--Manhattan Scientifics, Inc. (OTCBB: MHTX) announced today that its "early cancer detection" technology, developed by Edward R. Flynn, Ph.D. is expected to identify breast cancer three years earlier than the current gold standard mammogram test. Dr. Flynn is a pioneer in the emerging field of nano medicine.

When fully developed and commercialized, Dr. Flynn's biomagnetic-based system will be 100% radiation free, unlike current radiation-based mammogram tests. Manhattan Scientifics is currently seeking a partner to commercialize the technology.

To reduce harm from over-treatment and radiation, new medical guidelines recently issued by the U.S. Preventive Services Task Force recommended that women begin regular breast cancer screening at age 50, rather than age 40. "Annual mammograms for most women in their 40's have more drawbacks than benefits...." according to an article published by Bloomberg News, November 17, 2009.

CEO Manny Tsoupanarias said, "We believe early detection of cancer can be critical to effective treatment. Current mammography cannot detect a breast cancer tumor until it has grown to over ten million cells. Dr. Flynn's technology has proven the ability to detect breast cancer tumors only 1% that large, resulting in a hundred-fold increase in sensitivity and early detection.

"The new technology has demonstrated similar early detection performance for ovarian cancer, a cancer that currently has no effective screening techniques. Our technology also demonstrated effectiveness in monitoring chemotherapy for leukemia, allowing more effective treatment with fewer side effects. Dr. Flynn's work has been supported for eight years by nine grants from the National Institutes of Health and a grant from the U.S. Department of Defense. The technology is protected by issued and pending patents," Tsoupanarias said

source: Manhattan Scientifics Inc.

4.21.2010

Montgomery Breast Center First To Install Breast Cancer Lesion-Localization System

The Montgomery Breast Center of Montgomery, Ala., is the first center in the country to install and use the GammaLoc® lesion-localization system. This system is the only FDA-cleared device that enables gamma-guided, minimally invasive needle biopsy of suspicious lesions identified with Breast-Specific Gamma Imaging (BSGI). BSGI is performed by the Dilon 6800®, a gamma camera that is optimized to reveal lesions independent of tissue density and discover early stage cancers that are oftentimes not identified with other imaging methods, such as mammography, ultrasound and magnetic resonance imaging (MRI).

GammaLoc® helps the physician calculate the specific depth and location of the suspect lesion. A computer user interface with detailed step-by-step instructions guides the physician through the biopsy procedure. The GammaLoc® system utilizes a CorreLocator™ paddle and a StereoView™ imaging collimator system a technique similar to that used in stereotactic X-ray localization.

source: Medical News Today

4.19.2010

Innovation in Mathematics Leads to Revolutionary Breast Imaging System

TechniScan's scientific breakthrough in Inverse Scattering presented to doctors and scientists at AIUM conference

SALT LAKE CITY, April 7 /PRNewswire-FirstCall/ -- The groundbreaking algorithms developed at TechniScan, Inc. (OTC Bulletin Board: TSNI) have led to a new arena of whole breast ultrasound technology, as presented at a national medical ultrasound conference in San Diego in March.

TechniScan cofounder and scientist-mathematician, James Wiskin, Ph.D. spoke at the American Institute of Ultrasound Medicine (AIUM) conference held at the San Diego Marriott Hotel and Marina about the unique methods in which the company's 3-dimensional whole breast ultrasound captures anatomical images of the breast.

The breakthrough in imaging is a result of Wiskin's and colleagues David Borup, Ph.D., and Steven Johnson's, Ph.D. work in the mathematics of inverse scattering. TechniScan's Warm Bath Ultrasound™ (WBU) system uses a unique combination of traditional B-mode (reflective) ultrasound and two types of transmission ultrasound – speed of sound and attenuation of sound, to produce three unique sets of images.

"This revolutionary new method of imaging produces information not available with traditional reflection ultrasound or whole breast ultrasound as it is presently being developed. Uniquely, we can also capture 360 degree compounded coronal images," said Wiskin.

source: PR Newswire

4.02.2010

Pioneering Breast Scanner Holds Great Promise for Accurately Detecting and Diagnosing Breast Cancer at Its Earliest Stages

CHARLOTTESVILLE, Va., April 1, 2010 - Perhaps no one can appreciate the importance of early cancer detection as much as Izora Armstrong. That's because UVA Cancer Center researchers, using a first-of-its-kind hybrid breast imaging device, found what mammography, ultrasound, MRI and even a needle biopsy couldn't.

"I feel truly blessed that I came to UVA, that they gave me the chance to be a part of this study," says Armstrong, 53, a school bus driver in southern Fauquier County. "I went through all the regular tests and did what women are supposed to do and I still wouldn't have known I had breast cancer if it wasn't for UVA."

The unique device, the dual modality tomographic (DMT) breast scanner, developed by UVA researchers, has shown in its pilot study the ability to pinpoint to a much finer degree the exact location of breast masses - and, even more important, to more accurately distinguish between cancerous and harmless lesions.

The pilot clinical study, led by Mark B. Williams, PhD, associate professor of radiology, biomedical engineering and physics at the University of Virginia, appears in the April 2010 issue of Radiology.

The DMT breast scanner works by marrying two cutting-edge imaging methods, one that obtains 3-D anatomical (structural) imaging and another that obtains 3-D biological (functional) imaging, into one integrated device. The machine runs the scans sequentially, obtaining both types of images with the breast in the same, immobilized position.

source: University of Virginia Health System

3.27.2010

Study questions whether screening really cuts breast cancer deaths

A study from Denmark published on bmj.com today finds no effect of the Danish screening programme on breast cancer deaths.

Similar results have been seen in other countries, including the UK, leading the authors to question whether screening has delivered the promised effect on breast cancer mortality.

A 2005 study suggested that screening had reduced breast cancer deaths by 25% in Copenhagen. But Karsten Jørgensen and Peter Gøtzsche from the Nordic Cochrane Centre in Copenhagen, together with Per-Henrik Zahl from Folkehelseinstituttet in Oslo, identified important problems in this study and decided to undertake a more comprehensive analysis of the data.

They compared annual changes in breast cancer deaths in two Danish regions offering publicly organised screening programmes (Copenhagen and Funen county) with non-screened regions across the rest of Denmark.

Their analysis covered 10 years after screening could have had an effect on breast cancer mortality. For comparison, they also looked at the 10-year period before screening was introduced.

Data for each area were divided into three age bands. Women aged 55-74 years, who could benefit from screening, and women aged 35-55 years and 75-84 years, who were largely unaffected by screening.

They found that in women who could benefit from screening (55-74 years) breast cancer mortality declined by 1% per year in the screened areas and by 2% per year in the non-screened areas. In women too young to benefit from screening (35-54 years), breast cancer mortality declined by 5% per year in the screened areas and by 6% per year in the non-screened areas during the same period.

source: EurekAlert

3.20.2010

Intelerad to Showcase IntelePACS Breast Imaging at the 20th Annual National Interdisciplinary Breast Center Conference

Intelerad Medical Systems will be demonstrating the new IntelePACS® Breast Imaging fully-integrated, multi-modality mammography solution at the 20th Annual National Interdisciplinary Breast Center Conference.

IntelePACS Breast Imaging provides radiologists with instant access to a universal multi-modality worklist that drives the workflow and viewing process, answering the specific needs of high-volume mammography imaging departments and businesses. Radiologists can report studies securely over wide area networks, working collaboratively by accessing images and reports from any location. Robustness in image storage and delivery, including the use of compression to optimize transmission over any network are just some of the strengths of IntelePACS.

“IntelePACS Breast Imaging with its universal worklist eliminates the need for dedicated workstations, and gives access to multi-modality images regardless of where our radiologists read from. We especially like that the viewing tools are fully customizable offering us a high degree of control for image viewing. Workflow optimization within a single unified PACS environment will quickly ensure productivity gains and faster report turnaround times to patients and a better service to our referring physicians.” Peter Ricci, MD, Radiology Imaging Associates / Invision, Sally Jobe Breast Network.

source: Intelerad

3.15.2010

PEM scanners may reduce unnecessary breast biopsies and offer an alternative for women who cannot tolerate MRI.

SAN DIEGO, CA – March 15, 2010 – New data from an
NIH-sponsored, multi-site study of hundreds of women
with newly diagnosed breast cancer shows that
Positron Emission Mammography (PEM) may reduce
unnecessarybreast 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 on lesions that 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 im provement in
specificity at comparably high sensitivity, but that
PEM also had 31 fewer unnecessary biopsies and 26%
higher PPV than Breast MR. These results are also
particularly significant for those women who cannot
tolerate an MR exam and require an alternate imaging tool.

source: Naviscan

3.09.2010

MRI Finds Tumors In Second Breast Of Women Diagnosed With Cancer In One Breast

Postmenopausal women, including those over 70 years old, who have been newly diagnosed with cancer in one breast have higher cancer detection rates when the other breast is scanned for tumors with MRI, compared to premenopausal women, say researchers at the Mayo Clinic campus in Florida.

They found that 3.8 percent of 425 women had breast cancer in the undiagnosed breast that had not been found with a clinical or mammographic examination; all were postmenopausal. In these women, detecting and treating cancer in both breasts at the same time may save costs, patient stress, and the potential toxicity that may come from having to treat cancer later in the second breast once it is discovered, the researchers say in the March/April issue of The Breast Journal.

source: Medical News Today

2.23.2010

ACR, SBI: Avon Survey Reveals Potentially Deadly Effects of USPSTF Mammography Recommendations

A recent Avon Foundation for Women survey confirms what the American College of Radiology and other experts warned would happen: states are using deeply flawed and widely discredited U.S. Preventative Services Task Force mammography recommendations to deny women coverage for mammograms, and many women are foregoing long proven, life-saving mammography care based on the mistaken USPSTF recommendations.

According to the Avon national survey of cancer health educators and providers, respondents from more than a dozen states reported changes in their states’ breast and cervical cancer early detection programs following the USPSTF recommendations including the elimination of early screening programs for women under age 50. Avon reports that California, New York, Florida, Illinois and Michigan are among those states that have changed their breast cancer screening programs since the USPSTF released its guidelines. Respondents to the Avon survey also reported a decline in the number of women under 50 seeking mammograms and that many women already reluctant to have a mammogram are using the guidelines as their rationale to put off screening.

“Allowing a small number of people with no demonstrated expertise in breast cancer care to make recommendations regarding diagnosis of the nation’s second leading cancer killer makes no scientific sense, and has set a off a chain of political and clinical events that many women may ultimately pay for with their lives,” said James H. Thrall, MD, chair of the American College of Radiology Board of Chancellors. “Lawmakers at all levels need to act now to ensure that these recommendations do no further damage, and that women have full and ready access to mammography.”

source: American College of Radiology

2.22.2010

New Ultrasound Breast Scanner Takes Up Operation In Europe

The first models of the new Siemens ultrasound system Acuson S2000 Automated Breast Volume Scanner (ABVS) have taken up operation in European radiological and gynecological clinics and offices. Patients in Switzerland, France, Portugal, Norway and Germany can now be examined with the new system. Thanks to its more accurate, three-dimensional image acquisition, the technology is particularly suitable for the diagnosis of very dense breast tissue. Dr. Frank Stöblen of the Diavero Diagnostic Center in Essen, Germany, is one of the first physicians to use the new ultrasound technology. "The ABVS system is a fascinating advancement from the previous method of manually guided ultrasound examinations. The automated system provides consistent image quality, regardless of the examiner."

Siemens Healthcare recently introduced the Acuson S2000 ABVS, the world's first multifunctional ultrasound breast scanner that automatically acquires volume images of the female breast. The user-independent, standardized images raise ultrasound examinations to a completely new level.

source: Medical News Today

2.16.2010

Preoperative MRI Deemed Unnecessary in Women with Early-stage Breast Cancer

Researchers from the UK affiliated with the COMICE randomized trial have reported that preoperative magnetic resonance imaging (MRI) does not affect reoperation rates in women with early-stage breast cancer. The details of this study appeared in the February 13, 2010 issue of the Lancet.[1]

Preoperative MRI is increasingly being used in women with early-stage breast cancer who are undergoing breast-conserving surgery (lumpectomy) in order to detect additional areas of disease that may need to be removed but weren’t detectable with conventional imaging. The use of preoperative MRI is based on the assumption that it improves surgical planning, reduces follow-up surgery, and reduces the risk of local recurrence.

However, researchers from the University of Sydney, Australia, and the University of Michigan Comprehensive Cancer Center have reported that preoperative MRI in early breast cancer leads to more extensive surgery without evidence of improvement in surgical outcomes or long-term prognosis. This conclusion was based on more than 20 studies evaluating the impact of MRI on detection and surgical treatment in women with early-stage breast cancer. These researchers concluded that more research is needed—in the form of randomized, controlled trials—to evaluate preoperative MRI in breast cancer patients. In the meantime they conclude that MRI causes false-positives and unnecessary surgery and does not appear to reduce re-excision rates. They assert that preoperative MRI may actually do more harm than good.

source: CancerConsultants

1.23.2010

Digital Mammography Delivers Significantly Less Radiation than Conventional Mammography

Data from one of the largest mammography trials in history demonstrates that overall the radiation dose associated with digital mammography is significantly lower (averaging 22 percent lower) than that of conventional film mammography and that the reduction could be greater in women with larger and denser breasts, according to a study published in the February issue of the American Journal of Roentgenology.

“The ability to reduce the radiation dose for many women is another step forward for breast cancer screening with mammography — which saves thousands of lives each year,” said R. Edward Hendrick, PhD, lead author of the study.

The American College of Radiology Imaging Network (ACRIN) Digital Mammographic Imaging Screening Trial (DMIST) published in 2005, enrolled 49,528 women and found that digital mammography detected significantly (up to 28 percent) more cancers than film mammography in women younger than 50 years of age, premenopausal and preimenopausal women, and women with dense breasts.

In this latest DMIST study, published in AJR, technical data from 5,102 DMIST participants were evaluated, demonstrating that the dose received by women imaged with digital mammography was significantly lower than that received by the same women imaged with standard film mammography.

“The average breast radiation dose per view was 2.37 mGy for film mammography and 1.86 mGy for digital (22 percent lower for digital than film mammography),” said Hendrick.


source: ARRS

1.05.2010

Breast Cancer Screening Should Begin at Age 40, New Recommendations Suggest

ScienceDaily (Jan. 5, 2010) — The new recommendations from the Society of Breast Imaging (SBI) and the American College of Radiology (ACR) on breast cancer screening, published in the January issue of the Journal of the American College of Radiology (JACR), state that breast cancer screening should begin at age 40 and earlier in high-risk patients. The recommendations also suggest appropriate utilization of medical imaging modalities such as mammography, magnetic resonance imaging (MRI), and ultrasound for breast cancer screening.

"The significant decrease in breast cancer mortality, which amounts to nearly 30 percent since 1990, is a major medical success and is due largely to earlier detection of breast cancer through mammography screening," said Carol H. Lee, MD. "For women with the highest risk of developing breast cancer, screening technologies in addition to mammography have been adopted," said Lee.

source: Science Daily Release

1.04.2010

Baylor Adds Naviscan PEM Technology to Women’s Imaging Center

The Baylor University Medical Center in Dallas has taken delivery of the Naviscan PEM scanner at its Darlene G. Cass Women’s Imaging Center. Baylor will use PEM (positron emission mammography) to complement their existing anatomical tools by providing a three-dimensional metabolic perspective of breast cancer. The metabolic view allows physicians to make cancer care decisions by providing an improved ability to distinguish between benign and malignant lesions in what researchers call “specificity.” A recent multi-center NIH-sponsored study comparing PEM and MRI highlighted that PEM had improved specificity relative to MRI at comparable sensitivity, what researchers use to describe the ability to see lesions.

The Darlene G. Cass Women’s Imaging Center has been providing breast imaging services in the Dallas area for more than 20 years, performing more than 50,000 breast imaging procedures annually. The center also performs mammography, stereotactic breast biopsy, breast ultrasound, and ultrasound-guided breast biopsy.

source: NEMA