Baylor Adds Naviscan PEM Technology to Women's Imaging Center

SAN DIEGO, Dec. 22 /PRNewswire/ -- 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 utilize PEM (Positron Emission Mammography) to complement their existing anatomical tools by providing a critical three-dimensional metabolic perspective of breast cancer. The metabolic view allows physicians to make the optimal cancer care decisions by providing an unprecedented 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 a leader in breast imaging services in the Dallas area for more than 20 years, performing more than 50,000 breast imaging procedures annually. The Women's Imaging Center, which is fully accredited in mammography, stereotactic breast biopsy, breast ultrasound and ultrasound-guided breast biopsy, now adds PEM to its imaging services.

source: Naviscan

How Do You Improve Mammogram Accuracy? Add Noise

Members of a Syracuse University research team have shown that an obscure phenomenon called stochastic resonance (SR) can improve the clarity of signals in systems such as radar, sonar and even radiography, used in medical clinics to detect signs of breast cancer. It does this by adding carefully selected noise to the system.

The result has been a distinct improvement in the system's ability to correctly identify precancerous lesions, plus a 36 percent reduction in false positives. The inventors have developed a novel method of calculating precisely the correct type and level of noise to add to existing noise in radiography or a similar system.

source: Medical News Today

Elevated-Risk Women Refuse MRI Breast Cancer Screening

ScienceDaily (Dec. 22, 2009) — In a new study published in the January issue of Radiology, 42 percent of women eligible for breast cancer screening with MRI declined to undergo the procedure.

"Given that MRI is promoted as a very sensitive test to identify early breast cancer, we were surprised that barely half of women at increased risk for breast cancer would undergo MRI even when offered at no cost," said Wendie A. Berg, M.D., Ph.D., breast imaging specialist at American Radiology Services, Johns Hopkins -- Green Spring Station in Lutherville, Md. "This suggests the need for alternative methods, such as ultrasound, to help screen women at increased risk for breast cancer."

Some groups of women who are at high risk for breast cancer need to begin screening at a younger age, because they often develop cancer earlier than women at average risk. However, women below age 50 are more likely to have dense breast tissue, which can limit the effectiveness of mammography as a screening tool.

source: Science Daiy release

Dilon Diagnostics Gamma-Guided Localization System Cleared by FDA

GammaLoc(R) Helps Locate Breast Lesions Quickly and Accurately for Biopsy

NEWPORT NEWS, Va., Dec. 21 /PRNewswire/ -- Dilon Diagnostics announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its lesion-localization system for molecular imaging biopsy guidance.

GammaLoc(®), pronounced "gamma-loke", is a complementary technology to Dilon's cornerstone product, the Dilon 6800(®) Gamma Camera. The GammaLoc(®) (GL) system will help doctors accurately locate breast lesions and enable gamma-guided biopsies, particularly useful for patients that have findings on the Dilon system that are not revealed with other imaging modalities.

The GammaLoc(® )system utilizes a CorreLocator(TM) paddle and a StereoView(TM) imaging collimator system - a technique similar to that used in stereotactic X-ray localization, and the GammaLoc(®) software calculates the specific location of the suspect lesion. The compact design allows for breast biopsies with optimal patient comfort; and the entire system is small and portable, allowing physicians to perform molecular imaging guided biopsy procedures anywhere on site.

"Thanks to the superior performance of the Dilon 6800 camera combined with this new biopsy-guidance capability, physicians will find it easier to locate suspicious lesions seen with molecular breast imaging, greatly facilitating and expediting the biopsy process," said Robert Moussa, President and CEO of Dilon Diagnostics. "This recent innovation helps physicians improve patient management and confidently deliver faster, more accurate results to their anxious patients."

source: PR Newswire

Mammography Use and False Positives Among Women Younger Than 40 Years Old Differ Between Minority Populations

HOUSTON - Breast cancer screening guidelines generally recommend mammography begin at age 40. However, based on prior national research, an estimated 34 percent of non-Hispanic black women, 30 percent of non-Hispanic white women and 22 percent of Hispanic women aged 30 to 39 have reported having a mammogram.

"Our goals are to better understand who these women are that are getting mammograms at such a young age and their outcomes," said Julie M. Kapp, Ph.D., M.P.H., assistant professor at the University of Missouri-Columbia and lead author of the study, who presented the data at the American Association for Cancer Research Frontiers in Cancer Prevention Research Conference, Dec. 6-9 in Houston.

Through the NCI Breast Cancer Surveillance Consortium, the researchers examined the first mammograms of women aged 18 to 39 with no prior history of breast cancer. The sample included 99,615 mammograms.

Even though the risk of developing breast cancer before age 40 is lower than 1 percent, research showed that the majority of first mammograms in this study were for screening purposes, rather than evaluation of a breast problem. Screening mammograms ranged from 69 percent among black women to 81 percent among Asian women.

source: AACR

New FDA Approved Breast Cancer Screening Tool

SCOTTSDALE, Ariz., Dec. 6 /PRNewswire/ -- The FDA has approved new technology that now allows radiologists to detect breast cancer sooner and faster. The SonoCine Automated Whole-breast Ultrasound Method and is being offered by only one facility in Arizona - Arizona Breastnet, in Scottsdale. This unique technology is designed specifically as a breast cancer screening tool to enhance yearly mammography screening. Until now, ultrasound has only been used for diagnostic purposes - not for screening for breast cancer.

A new study, published in European Radiology, found that adding the SonoCine automated whole-breast ultrasound exam to the annual mammogram doubled the number of cancers found in a group representing approximately 40% of all women seeking annual mammograms. This contrasts with previous studies which have examined the use of additional tests only on women with significantly elevated risks of developing breast cancer.

Local radiologist, Belinda Barclay-White, MD, is the first physician to offer this technology in Arizona, and has already experienced its powerful capabilities.

According to Dr. Barclay-White, "87% of all breast cancers are found in women who have none of the traditional risk factors, such as family history. There have been many studies done on women with the BRAC1 and BRAC2 breast cancer gene and other risk factors, but not much is being done for relatively normal women for whom the mammogram does not always provide a complete picture."

source: PR Newswire

Philips Introduces Multi-modality Breast Workspace to Complement Comprehensive Portfolio of Diagnostic Imaging Solutions for Breast Care

Chicago, USA – At this year’s annual meeting of the Radiological Society of North America (RSNA), Royal Philips Electronics (NYSE: PHG, AEX: PHI) will introduce the Integral Breast Workspace, a set of solutions that provides radiologists the ability to review multi-modality breast images at one workspot to help drive quality and efficiency. Showcasing its commitment to breast care, Philips will also highlight new capabilities for its portfolio of diagnostic imaging systems in Mammography, Ultrasound and MRI.

Globally, breast cancer is the leading cause of cancer death among women. New guidelines suggest a multi-modality approach to screening, diagnosis and management. With an increasing number of patients and the need to review data from multiple modalities, radiologists are challenged with keeping up with the volume of studies that must be interpreted and reported on multiple workstations. Philips Integral Breast Workspace addresses this need for integrated image and information management.

"Think of all the duplicate work we currently do with all the separate systems," said Gillian Newstead, M.D., director of Clinical Breast Imaging at the University of Chicago. "Integration will save us a lot of time. And, at the same time it connects to better care for the patients by more accurately relating findings from the different modalities."

source: Philips Healthcare

Elastography Reduces Unnecessary Breast Biopsies

Elastography is an effective, convenient technique that, when added to breast ultrasound, helps distinguish cancerous breast lesions from benign results, according to an ongoing study presented at the annual meeting of the Radiological Society of North America (RSNA).

When mammography yields suspicious findings, physicians often use ultrasound to obtain additional information. However, ultrasound has the potential to result in more biopsies because of its relatively low specificity, or inability to accurately distinguish cancerous lesions from benign ones. Approximately 80 percent of breast lesions biopsied turn out to be benign, according to the American Cancer Society.

source: Medical News Today

Short-Term Follow-Up: A Reasonable Alternative to Immediate Biopsy of Palpable Breast Lesions With Benign Imaging Features

Short-term follow-up is a reasonable alternative to invasive biopsy of palpable (capable of being touched or felt) breast lesions with benign imaging features, particularly in younger women with probable fibroadenoma (non-cancerous tumors that often occur in women during their reproductive years), according to a study published in the December issue of the American Journal of Roentgenology.

The study, performed at the University of Virginia in Charlottesville, Va., consisted of a group of 320 women with 375 palpable masses with benign features for which short-term follow-up was recommended. “We found that only one case of cancer was diagnosed for which short-term follow-up had been recommended,” said Jennifer A. Harvey, M.D., lead author of the study.

“Our study of palpable breast lesions with benign features showed an acceptably low prevalence of breast cancer - so low that short-term follow-up is a reasonable alternative to biopsy,” said Harvey.

“Application of the results of our study may reduce the number of biopsies that result in benign findings. There is also significant cost savings associated with using short-term follow-up rather than immediate biopsy,” she said.

source: American Roentgen Ray Society

Esteemed Endorsements Recognize Promising Future Of Breast-Specific Gamma Imaging (BSGI)

Breast-Specific Gamma Imaging/Molecular Breast Imaging (BSGI/MBI) has been recognized and endorsed by two highly esteemed organizations for the fight against breast cancer: The Society of Breast Imaging (SBI) and the American College of Surgeons. Both societies published articles supporting the further application of this breakthrough imaging technology for the early detection of breast cancer.

"These endorsements reinforce what I have found to be true in my own center: BSGI performs better than MRI in many patient cases," Christine B. Teal, M.D., F.A.C.S. Director, Breast Care Center, The George Washington University Medical Faculty Associates. "BSGI is more sensitive and specific, and it costs less than MRI. We are a big supporter of BSGI in our breast center and use it routinely for the surgical planning for newly diagnosed breast cancer patients, as well as for screening of high risk patients."


source: Medical News Today

AMICAS PACS For Mammography at RSNA 2009

BOSTON, Nov. 12 /PRNewswire-FirstCall/ -- AMICAS, Inc. (NASDAQ: AMCS), a leader in image and information management solutions, today announced that it will showcase the intrinsic mammography capabilities of AMICAS PACS™ at the 2009 Radiological Society of North America (RSNA) annual meeting from November 29 to December 4 in Chicago, IL. AMICAS will be in the North Hall in booth #7124.

AMICAS PACS Version 6.0 delivers intrinsic mammography workflow and visualization tools, which helps drive a solid return on investment and increased productivity for radiologists. With intrinsic mammography and high-end tools for reading all radiology studies, AMICAS PACS provides for all of a radiologist's needs in a single, Web-based workstation.

"When AMICAS was developing its intrinsic mammography capabilities, they reached out to me - and other radiologists - to ensure that their radiology PACS fits into the real world of mammography," said Randy Hicks MD, radiologist and owner of Regional Medical Imaging of Flint, MI. "AMICAS actively solicits feedback from practicing radiologists, and I have found that this collaborative process delivers a superior PACS solution for my practice."

source: AMICAS

USPSTF Mammography Recommendations Will Result In Countless Unnecessary Breast Cancer Deaths Each Year

If cost-cutting U.S. Preventive Services Task Force (USPSTF) mammography recommendations are adopted as policy, two decades of decline in breast cancer mortality could be reversed and countless American women may die needlessly from breast cancer each year. The recommendations - created by a federal government-funded committee with no medical imaging representation - would advise against regular mammography screening for women 40-49 years of age, provide mammograms only every other year for women between 50 and 74, and stop all breast cancer screening in women over 74.

"These unfounded USPSTF recommendations ignore the valid scientific data and place a great many women at risk of dying unnecessarily from a disease that we have made significant headway against over the past 20 years. Mammography is not a perfect test, but it has unquestionably been shown to save lives - including in women aged 40-49. These new recommendations seem to reflect a conscious decision to ration care. If Medicare and private insurers adopt these incredibly flawed USPSTF recommendations as a rationale for refusing women coverage of these life-saving exams, it could have deadly effects for American women," said Carol H. Lee, M.D., chair of the American College of Radiology Breast Imaging Commission.

Since the onset of regular mammography screening in 1990, the mortality rate from breast cancer, which had been unchanged for the preceding 50 years, has decreased by 30 percent. Ignoring direct scientific evidence from large clinical trials, the USPSTF based their recommendations to reduce breast cancer screening on conflicting computer models and the unsupported and discredited idea that the parameters of mammography screening change abruptly at age 50. In truth, there are no data to support this premise.

source: American College of Radiology

Karmanos Cancer Institute Launches Company and Innovative Breast Imaging Tool

DETROIT, Nov. 16 /PRNewswire-USNewswire/ -- After more than 10 years of research and development, the Barbara Ann Karmanos Cancer Institute announced its launch of a new company to build and market a breast cancer screening device invented at Karmanos. The innovative technology developed as C.U.R.E. (Computerized Ultrasound Risk Evaluation), now referred to as SoftVue, will be marketed under the new spin-off company called Delphinus Medical Technologies, LLC. The company has already secured sale commitments for the SoftVue system from several health institutions nationally and internationally.

More than 300 women were involved in the initial clinical studies, which confirmed that SoftVue accurately and safely identifies breast cancer. SoftVue uses multi-parametric ultrasound and sophisticated computer algorithms rather than X-rays. The SoftVue exam takes about one minute, does not involve radiation or compression as the current mammography, and is a fraction of the cost of MRI (magnetic resonance imaging). It's believed that it will help reduce the number of false positives that can occur with mammography and thereby reduce unnecessary biopsies.

source: PR Newswire

Less is more in new breast-cancer screening recommendations

The long-standing recommendation that women age 40 and older at average risk of breast cancer get annual mammograms and the notion that women benefit from doing breast self-examination at home is being turned on its head. In a nod to the risks of false positives and unnecessary procedures that mammograms can generate, especially in younger women, the U.S. Preventive Services Task Force issued new guidelines this week saying women in their 40s who have average risk generally don’t need regular screening and that women 50 to 74 should cut back and get mammograms no more than once every two years. The group calls for a more individualized approach in deciding whether regular mammograms are warranted in cases that don’t involve a family history of the disease or genetic biomarkers that raise a woman’s risk for it.

The U.S. Preventive Services Task Force is an independent, nongovernmental body. Its new recommendations are at odds with those of other high-profile groups such as the American Cancer Society, which stands by its guidance that women in their 40s receive regular mammograms, and could affect the way private insurers and Medicare cover such screenings.

source: MarketWatch

AMICAS PACS For Mammography at RSNA 2009

BOSTON, Nov. 12 /PRNewswire-FirstCall/ -- AMICAS, Inc. (NASDAQ: AMCS), a leader in image and information management solutions, today announced that it will showcase the intrinsic mammography capabilities of AMICAS PACS™ at the 2009 Radiological Society of North America (RSNA) annual meeting from November 29 to December 4 in Chicago, IL. AMICAS will be in the North Hall in booth #7124.

AMICAS PACS Version 6.0 delivers intrinsic mammography workflow and visualization tools, which helps drive a solid return on investment and increased productivity for radiologists. With intrinsic mammography and high-end tools for reading all radiology studies, AMICAS PACS provides for all of a radiologist's needs in a single, Web-based workstation.

"When AMICAS was developing its intrinsic mammography capabilities, they reached out to me - and other radiologists - to ensure that their radiology PACS fits into the real world of mammography," said Randy Hicks MD, radiologist and owner of Regional Medical Imaging of Flint, MI. "AMICAS actively solicits feedback from practicing radiologists, and I have found that this collaborative process delivers a superior PACS solution for my practice."

"My practice is an ACR-certified Breast Imaging Center of Excellence, so it is important to me to be able to perform all of my reads - including digital mammography, breast MRI, breast ultrasound, BSGI, and all of my multi-modality breast biopsy images - on a single PACS workstation," said Dr. Hicks. "AMICAS has delivered a solution that improves my productivity and allows me to avoid expensive standalone workstations."

source: AMICAS

Study Finds Higher Risk Of Cancer Recurrence In Women With Dense Breasts

A new study finds that women treated for breast cancer are at higher risk of cancer recurrence if they have dense breasts. Published in the December 15, 2009 issue of Cancer, a peer-reviewed journal of the American Cancer Society, the study's results indicate that breast cancer patients with dense breasts may benefit from additional therapies following surgery, such as radiation.

Previous studies indicate that women with dense breast tissue are at increased risk of breast cancer. Researchers have suspected that high breast density may also increase the risk of cancer recurrence after lumpectomy, but this theory has not been thoroughly studied.

source: Medical News Today

High-Resolution Breast PET Improves Breast Cancer Detection

An NIH-sponsored, multi-year study of hundreds of women diagnosed with breast cancer found that Positron Emission Mammography (PEM) scanners significantly outperform MRI when differentiating between benign and cancerous lesions. The prospective study also found that the combination of PEM and breast MRI dramatically increases a physician's ability to detect potentially cancerous lesions over MRI alone, presenting a powerful combination for improving care. The findings released today mean that women and their physicians now have a better tool to help cure cancer.

PEM scanners are high-resolution breast PET systems 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. Other imaging systems, such as mammography and ultrasound, only show the location, not the metabolic phase. PEM scanners, which are about the size of an ultrasound system, are made in San Diego by Naviscan, Inc. and have been commercially available since 2007.

The NIH study examined 388 women with newly-diagnosed breast cancers, and unlike previous studies on primary lesions, focused on additional or secondary tumors. Understanding the presence of additional tumors is critical to understanding if a lumpectomy or mastectomy is the right surgery. Researchers found that PEM scans accurately distinguished 151 of 189 benign additional lesions, an 80% success rate in what researchers call "specificity." When the same lesions were subject to MRI scans, the specificity dropped to just 66%.

source: NaviScan

New Positron Emission Tomography (PET) Biomarker NVB-64 Visualizes Malignant Breast Tumors

Researchers at Thomas Jefferson University in Philadelphia, PA, supported in part by NuView Life Sciences, have published an article in the Journal of Nuclear Medicine reporting preclinical results of a novel PET biomarker designed to selectively detect malignant breast tumors[1]. "All tumors detected with the new biomarker were malignant and expressed the targeted VPAC1 receptors located on the plasma membrane of the tumor cells." These results have led to initiation of clinical trials, supported by NuView, at Jefferson using this agent in patients with known and suspected breast cancer.

To date, the unsettling report that a patient has a "suspicious mass" on an annual mammogram has automatically dictated a costly and invasive needle biopsy. Soon there may be a choice of care in selecting a diagnostic procedure to determine the benign or malignant nature of the mass. Rather than a protracted waiting period to locate a clinician, find time to schedule a biopsy, endure a painful procedure and wait additional days for lab results to be reported; novel procedures such as a NVB64-PET scan may eventually be available to discriminate between malignant and benign lesions.

source: Medical News Today

Breast-Specific Gamma Imaging Proves Cost-Effective For Pre-Surgical Planning Of Patients With Known Cancer Diagnosis

Breast-Specific Gamma Imaging (BSGI), a molecular breast imaging technique with comparable sensitivity to breast magnetic resonance imaging (MRI) for detecting breast carcinoma when used in pre-surgical planning for patients with known cancer diagnoses and is substantially less expensive than MRI, according to findings presented at the American Society of Clinical Oncology Breast Cancer Symposium in San Francisco, California.

"BSGI proved to be a cost-effective breast diagnostic imaging modality, able to detect mammographically occult breast cancers and provide comparable sensitivity to MRI at a higher patient compliance rate and lower cost," said Dr. Margaret Bertrand, Director of Breast Imaging at Solis Bertrand Breast Center in Greensboro, N.C.

source: Dilon Technologies

Diffuse Optical Tomography For Breast Cancer Screening Fine-Tuned By Researchers

Clemson University researchers in collaboration with researchers at the University of Bremen, Germany, are working to make the physical pain and discomfort of mammograms a thing of the past, while allowing for diagnostic imaging eventually to be done in a home setting.

The group is fine-tuning Diffuse Optical Tomography (DOT) to create high-resolution images from a scattering of infrared and visible light for the early detection of breast cancer. While the method is less expensive, safer and more comfortable than X-rays used in mammograms, the problem has been generating a strong enough resolution to detect smaller breast cancers.

source: Medical News Today

Studies Advance Early Detection, Evaluation and Treatment of Breast Cancer

SAN FRANCISCO – New studies on the early detection, evaluation and treatment of breast cancer were released today in advance of the 2009 Breast Cancer Symposium. The symposium is being held October 8-10, 2009, at the San Francisco Marriott.

Four major studies were highlighted today in a presscast (press briefing via live webcast):

* Majority of breast cancer deaths occur among women who don’t receive regular mammography: A large, retrospective study shows that nearly three-quarters of breast cancer deaths occur among the minority of women who do not undergo regular screening mammograms.
* Women under age 44 with DCIS have a higher risk of recurrence: A study reports that women with ductal carcinoma in situ (a pre-invasive form of breast cancer) age 44 and younger have almost double the risk of recurrence following breast conservation surgery and radiation therapy than women age 45 to 50, suggesting that more aggressive treatment should be studied in this population.
* Adding low-cost ultrasound prior to surgery can reduce need for second breast cancer surgery: An analysis demonstrates that the addition of axillary ultrasound prior to initial breast-conserving surgery spared nearly one-third of women with early-stage breast cancer who had underarm (axillary) lymph node metastases from a second breast cancer surgery to remove additional axillary nodes.
* New technique identifies breast cancer subtypes and predicts response to adjuvant paclitaxel (Taxol) chemotherapy: A study validates a novel method of tissue analysis, called tissue microarrays, for determining the “intrinsic subtype” of a breast tumor, and accurately uses breast cancer sub-typing to predict response to a specific anticancer drug. These findings will improve physicians’ ability to personalize treatment to maximize benefits and spare patients from unnecessary side effects.

source: American Society of Clinical Oncology

Digital mammography: A decade battling breast cancer

In addition to being Breast Cancer Awareness Month, this October is the tenth anniversary of digital mammography, a technology introduced by GE Healthcare in 1999. Similar to digital photography, digital mammography replaces the film used in traditional mammography with digital files viewed and stored on computers. To commemorate the anniversary and its long-standing commitment to fighting breast cancer, GE Healthcare created a digital wall of personal stories from those whose lives have been touched by breast cancer, as well as doctors, scientists and fundraisers who are fighting the disease.

Among those on the digital wall are Sylvia Soo and her personal story battling breast cancer at a young age. A flyover of Asia will take site visitors to Andra Pradesh in India, where Dr. Raghu Ram, after a successful career in the UK, returned with the mission to improve the delivery of breast cancer at home. Back in Europe, a tour of Belgium reveals a “Mammobiel” that is providing breast scans in rural areas.

GE pioneered the development of advanced breast-imaging technologies, making mammography devices since the 1960s. In 1999, GE Healthcare was the first company to introduce full-field digital mammography, having spent 13 years and more than $100 million developing the technology.

source: GE Medical

Canadian Breast Imaging System Ushers in New Era of Breast Cancer Management

CALGARY, Sept. 8 /CNW/ - Ontario biomedical engineer Cameron Piron is to receive a $25,000 prize from the Ernest C. Manning Awards Foundation for his development of a dedicated system for breast magnetic resonance imaging (MRI) and intervention.

MRI is a safe and sensitive imaging tool, but it can be challenging to obtain high quality images of breast tissue. Piron's system
incorporates several innovations that make breast MRI and biopsy highly sensitive, patient-friendly, efficient and cost effective. The Sentinelle Vanguard(R) Breast MRI Table with Variable Coil Geometry(TM) combines ingenuity in computing, engineering and medicine to allow radiologists to detect breast cancer even in its early stages.

Breast cancer affects more women worldwide than any other cancer; in Canada, an estimated 5400 women will die from it this year. With early detection, survival rates can improve from 21 to 96 percent. The Sentinelle Vanguard table allows the patient to be more comfortable while giving the radiologist easier access to the breast tissue in order to obtain MRI guided needle biopsies. The specially designed radiofrequency coils are adjustable to accommodate different body types and can be positioned close to the tissue to improve image resolution.

source: CNW Group

Swift And Accurate Breast Biopsies Via Full-Field Digital Mammography

Patients of the Mammography Department at NHS Fife's Queen Margaret Hospital are now benefitting from faster treatment due to the installation of a Full-Field Direct Digital Mammography system from Siemens Healthcare. The MAMMOMAT Inspiration™ includes a stereotactic biopsy attachment and syngo® MammoReport workstation.

The stereotactic biopsy attachment provides the clinician with valuable guidance through the biopsy procedure enabling vertical and lateral access to breast lesions, of particular use when trying to access technically challenging areas in the breast. The attachment has an easy to use set up and is lightweight, weighing less than 5kg. It also allows clinicians to control the tube angle directly from the workstation, eliminating the need to walk between the system and station.

The stereotactic biopsy attachment provides the clinician with valuable guidance through the biopsy procedure enabling vertical and lateral access to breast lesions, of particular use when trying to access technically challenging areas in the breast.

source: Medical News Today

Digital Mammography Plus Digital Breast Tomosynthesis May Decrease Patient Recall Rates

Nationally, about ten percent of women in the US are recalled for a second mammogram after an abnormality is detected on the first one—for most women this can be very stressful. However the use of digital breast tomosynthesis and full-field digital mammography combined may be associated with a substantial decrease in recall rate, according to a study performed at UPMC in Pittsburgh, PA. Some researchers believe that digital breast tomosynthesis depicts the breast tissue in a way which may allow radiologists to identify some tumors which could be missed with standard two-dimensional mammography.

The study included 125 patients that were evaluated using a combined method of digital breast tomosynthesis and standard digital mammography. “The use of digital breast tomosynthesis and full-field digital mammography (FFDM) was associated with a 30% reduction in recall rate for cancer-free examinations that would have led to recall if FFDM had been used alone,” said Jules H. Sumkin, MD, one of the authors of the study.

“Patient recalls are problematic at multiple levels. Patients pay an emotional price and it is a sheer inconvenience having to go back for a second appointment. It is also problematic for imaging facilities because they are faced with the high cost of resources required for the recalls,” he said.

“We are confident that recall rates could be decreased by adding breast tomosynthesis to FFDM,” said Dr. Sumkin. Digital breast tomosynthesis is not yet FDA approved.

source: ARRS

Enhanced Digital Breast Imaging From US Navy-Funded Technology

A breakthrough technology adapted for breast cancer detection based in part on research originally sponsored by the Office of Naval Research (ONR) is set to air July 23 during a CNN International news segment on Vital Signs, a program hosted by Dr. Sanjay Gupta.

The technology, referred to by the U.S. Navy as enhanced digital imaging, developed out of the Navy's need to improve capabilities to detect, localize and classify underwater mines. It later served as the point of departure for research conducted by the Naval Undersea Warfare Center, Division Newport (NUWC), part of the Naval Sea Systems Command (NAVSEA), designed to enhance the discrimination of data in complex underwater environments. Researchers at NUWC later patented the enhanced digital imaging process.

source: Medical News Today

Study Challenges Routine Use Of MRI Scans To Evaluate Breast Cancer

Reviewing the records of 577 breast cancer patients, Fox Chase Cancer Center researchers found that women with newly diagnosed breast cancer who receive a breast MRI are more likely to receive a mastectomy after their diagnosis and may face delays in starting treatment. The study demonstrates that, despite the lack of evidence of their benefit, routine use of MRI scans in women newly diagnosed with breast cancer increased significantly between 2004 and 2005, and again in 2006.

The study is online now and will be appearing in the August edition of the Journal of the American College of Surgeons.

source: Medical News Today

SOMO·INSIGHT Clinical Study Detects First Cancer in Mammographically Negative Breast Screening Patient at OSF Saint Francis Medical Center

SAN JOSE, Calif. & PEORIA, Ill.--(BUSINESS WIRE)--U-Systems, the leader in dedicated breast ultrasound systems, together with Medical Director Jessica A. Guingrich, MD of OSF Saint Francis Medical Center, Susan G. Komen Breast Center and Centers for Breast Health announced that they have initiated the SOMO·INSIGHT Clinical Study. The first participants have been enrolled and the first pathologically confirmed cancer has been detected in a mammographically-negative screening patient. The clinical study is examining whether Digital Mammography along with the somo•v™ Automated Breast Ultrasound (ABUS) is more sensitive to detecting breast lesions when compared to Mammography alone in women with dense breasts.

The initiation of this nationwide study, which intends to recruit over 20,000 women, is an important milestone for U-Systems in evaluating new approaches to improved cancer detection. Screening mammography can be limited in women with dense breasts and these women have a higher risk of breast cancer. ABUS uses ultrasound (sound waves) at a safe frequency to create images of the internal breast tissue, unlike mammography, which uses radiation. Ultrasound has been shown to find cancer not visible with mammography in women who have dense breasts. A new approach to improving breast cancer detection is critical for women with dense breasts who undergo mammography. It is for this reason that U-Systems developed the somo•v and is sponsoring the SOMO·INSIGHT clinical study.

source: Business Wire

FDA Clears Hologic R2™ DIGITALNOW™ HD Software Application

Software processes digitized prior film mammograms to produce DICOM images that more closely resemble digital mammograms

BEDFORD, Mass. (June 12, 2009) - 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, today announced that it has received Food and Drug Administration (FDA) clearance for its R2™ DigitalNow™ HD software application.

The R2 DigitalNow HD software is the only FDA-cleared application intended to process digitized screen-film mammograms for comparison purposes. The product is now available worldwide.

By collaborating with radiologists to understand the demands of reading digital mammograms, Hologic created the R2 DigitalNow HD software, which adapts each digitized film image to a selected contrast and tissue intensity that models a digital mammography system. It also embeds a series of look-up tables in the image that allow Integrated Healthcare Enterprise (IHE) mammography conformant workstations to draw out less evident regions of density within digitized films1 .

source: Hologic

Prototype Breast Cancer Imaging System May Improve Patient Care

ScienceDaily (June 15, 2009) — A prototype breast imaging system combining positron emission tomography (PET) and magnetic resonance imaging (MRI) technologies could greatly improve breast cancer imaging capabilities, according to researchers at SNM's 56th Annual Meeting. Although the system has not yet been tested on humans, initial results from the prototype indicate the system produces a fusion of detailed PET and MRI images that should allow a more accurate classification of lesions in the breast.

"PET and MRI systems are both powerful, noninvasive tools for detecting breast cancer and evaluating treatment, but each of them also has weaknesses," said Bosky Ravindranath, research assistant working with Dr. David Schlyer at Brookhaven National Laboratory, Upton, N.Y., and lead author of a study on preliminary testing of the prototype. "We believe that combining PET and MRI in a single system will eventually yield highly sensitive and specific breast cancer examinations while at the same time compensating for the shortcomings that exist when using only PET or only MRI."

source: Science Daily (press release)

Breast MRI shows it’s not the size of the lymph node that signals spread of cancer

Physicians treating breast cancer first look to lymph nodes in a patient’s armpit to see whether cancer is spreading elsewhere in the body — but they may not be evaluating the nodes in the most effective way.

Initial research suggested that enlargement and abnormalities of axillary sentinel lymph nodes – located in the armpit area near the breast – were predictive of cancer. But a University of Florida Shands Cancer Center researcher says it’s not the size of the node or enhancement, but the loss of a key part of a normal node’s structure called the fatty hilum that more accurately signals the spread of disease. The findings are available online in the Journal of Magnetic Resonance Imaging.

In addition to changing ideas about what doctors should look for while evaluating lymph nodes, the finding reinforces the value of using MRI to determine the extent of breast cancer prior to surgery.

source: University of Florida College of Medicine

Siemens Mammomat Inspiration Wins Design Awards

Mammomat Inspiration, the digital mammography platform designed by Siemens and designaffairs, has received the iF Product Design Award 2009 and the red dot award: product design 2009. The device for the early detection of breast cancer shows that ease of use, high functionality, and unique design come together beautifully in a single medical engineering product.

Siemens Healthcare and designaffairs jointly designed the Mammomat Inspiration, the first mammography system to incorporate the MoodLight function. MoodLight is an LED glass panel that can be illuminated with freely selectable colors, producing a comfortable, relaxing effect on the patient.

Since 1953, the iF Industrie Forum Design e.V. has presented the internationally recognized iF awards annually. The awards celebrate products that excel with a unique combination of functionality, user friendliness, and esthetics, and meet all the criteria of an innovation. Mammomat Inspiration from Siemens won one of the iF Design prizes in the Medicine / Health+Care category. A total of 802 awards were presented among the 2,808 applicants from 39 countries.

source: Siemens Healthcare

External Beam Partial Breast Irradiation Most Cost-effective Treatment

External beam partial breast irradiation (EB-PBI) is the most cost-effective method for treating postmenopausal women with early-stage breast cancer based on utilities, recurrence risks and costs when compared to whole breast radiotherapy (WBRT) and brachytherapy partial breast irradiation (brachy-PBI), according to a study in the June 1 issue of the International Journal of Radiation Oncology*Biology*Physics, the official journal of the American Society for Radiation Oncology (ASTRO).

PBI is a newer form of radiation therapy for breast cancer where only part of the breast is treated twice a day for four to five days. Radiation oncologists have been studying different methods to deliver the radiation to the tumor. EB-PBI uses high-energy external X-rays to deliver radiation to the breast after a lumpectomy and brachy-PBI delivers radiation through either implanted needles or a small sphere placed into the post-lumpectomy cavity in the breast.

source= ASTRO

Breast MRI Detects Additional "Unsuspected" Cancers Not Seen On Mammography Or Ultrasound

Nearly 20% of patients with recently diagnosed breast cancer had additional malignant tumors found only by MRI, according to a study performed at Dartmouth Hitchcock Medical Center.

A total of 199 patients with newly diagnosed breast cancer underwent breast MRI. "We found additional, unsuspected cancers in the ipsilateral breast (the one that had already been diagnosed with cancer) in 16% of patients; we found cancers in the contralateral breast (the one that had not been diagnosed with cancer) in 4% of patients," said Petra J. Lewis, MD, lead author of the study. "These patients had already had bilateral mammography and these tumors had not been apparent on mammography," said Dr. Lewis.

source: Medical News Today

Germany's Göttingen University Buys ART SoftScan Optical Breast Imaging System

Montreal, Canada, May 12, 2009 - ART Advanced Research Technologies Inc. ("ART") (TSX: ARA), a Canadian medical device company and a leader in optical molecular imaging products for the healthcare and pharmaceutical industries, announced today that it has received a purchase order for one of its SoftScan® breast imaging systems from the Department of Radiology of the University Medical Center Göttingen, in Germany.

"We are very proud to see that the interdisciplinary molecular imaging group of the University of Göttingen, in cooperation with the Max-Planck-Institute of Experimental Medicine, has chosen our SoftScan breast imaging system to conduct world-class research in the field of translational oncology and radiology and to have them among our growing base of clients," said Sébastien Gignac, Chairman & CEO of ART. "The fact that the Interdisciplinary Imaging Group Göttingen, in which radiologists, oncologists, physicists, molecular biologists, imaging scientists and chemists work in close collaboration, has ordered a SoftScan system is testimony to the power of our technology to address the needs of leading researchers in the field of oncology," added Mr. Gignac.

source: ART

ARRS 2009: Diffusion-Weighted Imaging May Improve Accuracy of Breast MRI

May 4, 2009 (Boston, Massachusetts) — Diffusion-weighted imaging (DWI) used to distinguish malignant vs benign breast lesions during magnetic resonance imaging (MRI) is helpful and may reduce the number of unnecessary breast biopsies, according to new research.

DWI is a technique involving the exchange of water molecules (diffusion) between breast tissue compartments. Diffusion rates vary between normal and pathologic tissue. With DWI MRI, the MRI machine is set to detect small restrictions in the free movement of water within the breast. Restricted diffusion areas show as hot spots on the MRI.

"The main aim of our work is to help save women from unnecessary breast biopsies," said lead investigator R. El-Khouli, MD, who lead the study when she was at Johns Hopkins University School of Medicine in Baltimore, Maryland, but is now with the National Institutes of Health in Bethesda, Maryland. She presented study results here last week at the American Roentgen Ray Society (ARRS) 2009 Annual Meeting.

source: Medscape

3T MRI Detects “Early” Breast Cancer Not Seen on Mammography and Sonography

3T MRI, a powerful tool for evaluating patients with a high risk of having breast cancer, can detect a significant number of lesions not found on mammography and sonography, according to a study performed at the University of Toledo Medical Center, Toledo, OH.

The study included 434 women who underwent mammography, sonography and 3T MRI for the detection of malignant breast lesions—all women were at high risk. Results showed that 3T MRI detected 66/66 malignant lesions; mammography detected 54/66 malignant lesions; and sonography detected 57/66 malignant lesions. “3T MRI depicted a significantly higher number of malignant tumors of the breast than mammography and sonography,” said Haitham Elsamaloty, MD, lead author of the study.

“Our study detected ‘early’ breast cancer (lesions as small as 4 mm) in size and also identified malignant lesions that were only detected by MRI and confirmed by MRI guided biopsy. These crucial findings led to a significant change in patient management in 18.2% of the cases in our study.

“Our study suggests an important role for 3T MRI in such high risk groups for an early diagnosis of breast cancer and better accuracy in evaluating the extent of disease—a crucial factor in appropriate therapy planning,” said Dr. Elsamaloty.

source: ARRS

Integrating PACS with Digital Mammography was Focus of Presentation at NCBC Meeting

LAS VEGAS--(BUSINESS WIRE)--Integrating digital mammography with PACS proved far better than reading mammograms on mammo-only specialty workstations. That was the conclusion reported by a Pennsylvania hospital, in a poster presentation at the recent National Consortium of Breast Centers’ (NCBC) conference.

The presentation was by Peggy Wright, Supervisor of Women’s Imaging at Butler Health System, in Butler, Penn. She reported on using Butler’s Unity™ RIS/PACS from DR Systems to integrate digital mammography and PACS.

Butler concluded that integrating digital mammography with a mammography-oriented PACS helped the hospital avoid a costly space remodel. It also made reading, results reporting, and billing more efficient and provided better service to referring physicians.

“Not having to spend the capital for a space remodel was a key for us,” said Wright. “Even so, the advantages of integrating our digital mammography equipment with our PACS would probably have led us to that solution even without the space issue. Integrating digital mammography with the DR Systems PACS made it possible for us to reap the clinical and capacity-enhancing advantages of digital mammography, without a loss of efficiency and productivity.”

An imaging facility has two options for implementing full-field digital mammography (FFDM). It can integrate FFDM with its PACS so that all digital imaging modalities are read on the facility’s existing PACS workstation. Or it can have digital mammograms read on special mammography reading stations and mini-PACS acquired from an FFDM vendor.

source: Business Wire

Carestream Health’s Multi-Modality Breast Imaging Workstation Streamlines Digital Workflow, Improves Radiologist Productivity

ROCHESTER, N.Y., April 23 — Healthcare facilities nationwide are turning to vendor-neutral, multi-modality breast imaging workstations to streamline reading of digital breast exams.

“Productivity at many U.S. facilities is hampered by the need to read full-field digital mammography (FFDM) exams on each vendor’s proprietary workstation, and then switch to additional workstations to review other types of breast exams. The need for an efficient workflow is driving strong sales for our flexible multi-modality workstation,” said Stephen W. Archer, Director of Worldwide Marketing, Mammography Solutions, Carestream Health, Inc.

The KODAK CARESTREAM Mammography Workstation enables diagnostic review of all breast imaging exams (FFDM, ultrasound, MR, CR and others) as well as all general radiology exams.

source: Carestream

Further Testing With Breast-Specific Gamma Imaging (BSGI) Uncovers Additional Cancer in Breast Cancer Patients, Changes Surgical Management

NEWPORT NEWS, Va., April 27 /PRNewswire/ -- A study from Beth Israel Medical Center, New York, revealed today that additional breast cancer was found in 9 percent of patients when Breast-Specific Gamma Imaging (BSGI) was used to complement mammography, substantially impacting surgical treatment. A total of 82 patients underwent BSGI for newly diagnosed breast cancer; of these, 18 had an additional abnormality, and 17 were biopsied. The findings were presented at the American Society of Breast Surgeons 2009 Annual Meeting in San Diego.

BSGI, a molecular breast imaging technique, is an adjunct to mammography that can see lesions independent of tissue density and discover early stage cancers. With BSGI, the patient receives a pharmaceutical tracing agent that is absorbed by all the cells in the body. Due to their increased rate of metabolic activity, cancerous cells in the breast absorb a greater amount of the tracing agent than normal, healthy cells and generally appear as "dark spots" on the BSGI image. The Dilon 6800 Gamma Camera is a high-resolution, compact gamma camera, optimized to perform BSGI.

source: PR Newswire

3T MRI Detects “Early” Breast Cancer Not Seen on Mammography and Sonography

3T MRI, a powerful tool for evaluating patients with a high risk of having breast cancer, can detect a significant number of lesions not found on mammography and sonography, according to a study performed at the University of Toledo Medical Center, Toledo, OH.

The study included 434 women who underwent mammography, sonography and 3T MRI for the detection of malignant breast lesions—all women were at high risk. Results showed that 3T MRI detected 66/66 malignant lesions; mammography detected 54/66 malignant lesions; and sonography detected 57/66 malignant lesions. “3T MRI depicted a significantly higher number of malignant tumors of the breast than mammography and sonography,” said Haitham Elsamaloty, MD, lead author of the study.

“Our study detected ‘early’ breast cancer (lesions as small as 4 mm) in size and also identified malignant lesions that were only detected by MRI and confirmed by MRI guided biopsy. These crucial findings led to a significant change in patient management in 18.2% of the cases in our study.

“Our study suggests an important role for 3T MRI in such high risk groups for an early diagnosis of breast cancer and better accuracy in evaluating the extent of disease—a crucial factor in appropriate therapy planning,” said Dr. Elsamaloty.

“High field strength (3T) MRI systems are becoming increasingly available in the clinical setting and more of them are being used for the evaluation of breast malignancy. 3T MRI is an important addition to mammography and sonography,” he said.

This study appears in the April issue of the American Journal of Roentgenology. For a copy of the full study, please contact Heather Curry via email at hcurry@arrs.org.

source: ARRS

New Guidelines on Use of Breast MRI

New guidelines for the use of magnetic resonance imaging (MRI) for diagnosing breast cancer and making treatment decisions have been published in the Journal of the National Comprehensive Cancer Network (2009;7:193-201).

The key recommendations state that MRI should not be used as a substitute for screening or diagnostic mammography or diagnostic breast ultrasound, but rather as a supplement to those imaging techniques; that surgical decisions should not be based solely on MRI findings, and that suspicious lesions should be biopsied before a surgery plan is devised; that MRI can find the location of cancer in the breast in the rare cases that cancer is found in the lymph nodes but not in the breast; and that MRI provides enhanced detection in both breasts in women with diagnosed breast cancer.

source: Oncology Nursing News

Surgical Gel Used To Stop Bleeding Could Confuse Mammograms

MAYWOOD, Ill. -- Dr. Kathleen Ward noticed something odd when she examined the mammogram of a patient who had recently undergone breast cancer surgery.

The Loyola University Health System radiologist saw a suspicious pattern of white specks, much like grains of salt. The specks were calcium deposits similar to microcalcifications that sometimes are a sign of early breast cancer. But it was too early for the patient's breast cancer to have returned because it had been only a month since her lumpectomy.

It turns out the microcalcifications were not from cancer. Rather, they were due to a gel that is sometimes used during surgery to stop bleeding. In a recent article in the American Journal of Roentgenology, Ward and colleagues reported seven cases in which the sealant mimicked malignant microcalcifications in mammograms.

The sealant, FloSeal, "is not recommended for use on breast tissue," Ward and colleagues wrote. Ward is Medical Director of Women's Health Imaging and an assistant professor in the Department of Radiology at Loyola University Chicago Stritch School of Medicine.

source: Loyola Medicine

SenoRx Announces Launch of a New SenoSonix(tm) Model With a Portable Hand-Carry Laptop Ultrasound Component

IRVINE, Calif., Apr 9, 2009 (GlobeNewswire via COMTEX News Network) -- SenoRx, Inc. (Nasdaq:SENO) today announced the launch of an additional model of its SenoSonix(tm) System. Like the original SenoSonix, the new model is an integration of SenoRx's EnCor(r) breast biopsy system with ultrasound imaging. This new version of the device incorporates a microminiaturization ultrasound technology that combines personal computing power and flexibility. The new ultrasound component is designed, developed and manufactured by Terason, a division of Teratech Corporation, based in Burlington, Massachusetts. This versatile and unique ultrasound technology coupled with SenoRx's proprietary EnCor vacuum-assisted biopsy technology results in an attractive alternative model of the SenoSonix System for our customers. The modular design and sophisticated imaging architecture are now available in a reduced footprint with increased portability. The SenoSonix System received 510(k) clearance in October 2007 and CE Mark approval in April 2008.

"Our new SenoSonix model is designed to meet the needs of breast surgeons performing breast biopsy procedures utilizing ultrasound in both their offices and in the hospital surgery suite who wish to have the flexibility of moving the ultrasound component between the two locations," said Lloyd Malchow, SenoRx President and Chief Executive Officer. "The new system may be particularly well suited for markets in Europe and Asia where a significant percentage of biopsy procedures are performed utilizing ultrasound. We are pleased to be working with Terason on this compact portable solution. We will begin introducing this product in the U.S. and in select countries in which we have launched the EnCor breast biopsy system."

source:SeoRx

Computer Based Model Helps Radiologists Diagnose Breast Cancer

Radiologists have developed a computer based model that aids them in discriminating between benign and malignant breast lesions, according to a study performed at the University Of Wisconsin School of Medicine, Madison, WI. The model was developed by a multidisciplinary group, including radiologists and industrial engineers, led by Elizabeth S. Burnside, MD, Oguzhan Alagoz, PhD, and Jagpreet Chhatwal, PhD.

“The computer based model was designed to help the radiologist calculate breast cancer risk based on abnormality descriptors like mass shape; mass margins; mass density; mass size; calcification shape and distribution,” said Elizabeth S. Burnside, MD, and Jagpreet Chhatwal, MD, lead authors to the study. “When the radiologist combined his/her assessment with the computer model the radiologist was able to detect 41 more cancers than when they didn’t use the model. The model was created based upon findings of 48,744 mammograms in a breast imaging reporting database and found that the use of hormones and a family history of breast cancer did not contribute significant predictive ability in this context,” they said.

“One of the important roles of a radiologist is to interpret observations made on mammograms and predict the likelihood of breast cancer. However, assessing the influence of each observation in the context of an increasing number of complex risk factors is difficult for the human brain. In this study, we developed a computer model that is designed to aid a radiologist in breast cancer risk prediction to improve accuracy and reduce variability,” said Drs. Burnside and Chhatwal.

source: ARRS

New Computer Imaging System for Breast Augmentation in New Jersey

A new computer imaging system for breast augmentation is helping New Jersey patients plan better procedures. Dr. Evan Sorokin, a breast enlargement surgeon in New Jersey, says that the new Portrait 3D imaging system helps allow for more accurate results and greater peace of mind during recovery.

Marlton, N.J. (PRWEB) April 2, 2009 -- A local breast augmentation plastic surgeon is the first to offer patients in the greater Philadelphia and Southern New Jersey areas an opportunity to plan procedures more accurately using a technologically advanced computer imaging system. Dr. Evan Sorokin (http://www.delawarevalleybreasts.com), a board-certified plastic surgeon performing cosmetic and reconstructive procedures such as breast enlargement in New Jersey says that his patients are already benefiting from his practice's newly acquired digital imaging system, which offers the next generation of imaging technology and allows women to preview and compare possible surgical outcomes before surgery.

"I'm very excited to see how this system is already helping my patients clarify their goals," Dr. Sorokin says. "Today, since breast augmentation patients in New Jersey have so many options to choose from, I am always looking for new ways to simplify the decision-making process. My patients definitely appreciate being able to compare their options visually, and the system factors in each patient's skin and tissue type to more accurately reflect cosmetic surgery results."

source: eMediaWire

Merge Healthcare Enhances Mammography Review Solution

Milwaukee, WI, March 6, 2009 – Merge Healthcare (NASDAQ: MRGE), a leading medical imaging solutions provider, today announced the latest update to its Cedara I-ReadMammo vendor solution for digital breast imaging review. Version 6.5 is built on over 10 years of continuous development, making it one of the longest running, non-proprietary mammography review software in the industry. Since mammography is a high volume area of radiology subject to its own set of regulations, the software for reviewing these images must be highly specialized. Experience in meeting these regulations, while also allowing for efficient review, is critical.

Merge Healthcare’s Cedara I-ReadMammo 6.5 supports 10 bit medical monitors, which display up to 1,024 simultaneous levels of gray versus the 256 offered by 8-bit monitors. Merge partnered with Barco, a global display and visualization company, for quality control in the development. “I’m very pleased to see the full support for 10-bit precision image display added in version 6.5 of Cedara I-ReadMammo,” said Albert Xthona, Product Manager for Digital Mammography at Barco. “This image enhancement contributes to better mammography workflow, because the actual image interpretation goes faster.”

source= Merge Healthcare

Imaging Diagnostic Systems Achieves Technical Breakthrough with New Reconstruction Algorithm

FORT LAUDERDALE, Fla.--(BUSINESS WIRE)--Imaging Diagnostic Systems, Inc., (OTCBB:IMDS) a pioneer in laser optical breast cancer imaging systems, announced today that it has enhanced its CT Laser Mammography (CTLM®) system with a reconstruction algorithm that improves visualization of angiogenesis (cancer) in its images.

During a CTLM examination the breast is illuminated by a laser and the transmitted light is collected by a series of photo detectors and transformed into digital data. The reconstruction algorithm uses this data to create the various images of the breasts. The improved algorithm enhances the images by reducing the number of artifacts occasionally produced during an examination thereby making diagnosis easier.

“Our first-generation reconstruction algorithms were developed and evaluated using data acquired during our initial clinical trials. Since those trails, we have deployed over 26 systems worldwide, providing us with CTLM data from thousands of patients. IDSI’s Research & Development team used this data to optimize the reconstruction algorithms in order to provide better clarity and reduced artifact in CTLM images. We also incorporated streamlined numerical methods into the software so that the new algorithm does not require additional computing resources, allowing us to provide the improved functionality to existing customers as a software upgrade,” stated Steven Ponder, Ph.D., Director of Advanced Development/Imaging Diagnostic Systems.

source: Business Wire

Siemens Celebrates 1,000th Installation of Its All-in-One Digital Mammography Solution

Malvern, Pa., March 10, 2009 – Siemens Healthcare (www.siemens.com/healthcare) celebrates a milestone with the 1,000th installation of its MAMMOMAT® NovationDR, a full-field digital mammography system for screening, diagnostics, and biopsy applications. Susan B Allen Memorial Hospital, an 80-bed community hospital in El Dorado, Kansas, recently received the MAMMOMAT NovationDR, the first system to merge Siemens’ long-standing networking expertise with all the advantages of full-field digital mammography to optimize clinical workflow.

The MAMMOMAT NovationDR is designed to handle the mammography workup from patient registration and image acquisition to post-processing and reading. The system features Siemens’ exclusive dual anode technology. This tube offers three anode/filter combinations that match breast density and thickness – Mo/Mo, Mo/Rh, and W/Rh. With Tungsten technology and high mA output, even dense breasts are examined with shorter exposure times. Dose can be reduced by up to 50 percent, while maintaining image quality.

source: Siemens

Breast-Specific Gamma Imaging (BSGI) Can Reduce the Number of Unnecessary Breast Biopsies When Compared to MRI

Pivotal Study Presented at Interdisciplinary Breast Center Conference

NEWPORT NEWS, Va., March 18 /PRNewswire/ -- Women that require additional diagnostic imaging after a questionable mammogram may be at risk for unnecessary biopsies when only magnetic resonance imaging (MRI) is offered, according to a new study presented at the 19th Annual National Interdisciplinary Breast Center Conference in Las Vegas.

"Our goal was to see if BSGI could be used to improve upon the specificity of MRI, and also reduce the number of biopsies. The study is important because with the addition of BSGI, we could eliminate the need for 50 percent of biopsies or possibly change a patient's decision to have more radical surgery," said Dr. Leora Lanzkowsky, Director of Women's Imaging, CHW - Nevada Imaging Centers in Las Vegas.

BSGI has comparable sensitivity but superior specificity when compared to MRI. Sensitivity refers to the ability of an imaging technique to detect the presence of disease. Specificity refers to the technique's ability to detect that disease is actually not present.

source: PR Newswire

Siemens Celebrates 1,000th Installation of Its All-in-One Digital Mammography Solution

Malvern, Pa., March 10, 2009 – Siemens Healthcare (www.siemens.com/healthcare) celebrates a milestone with the 1,000th installation of its MAMMOMAT® NovationDR, a full-field digital mammography system for screening, diagnostics, and biopsy applications. Susan B Allen Memorial Hospital, an 80-bed community hospital in El Dorado, Kansas, recently received the MAMMOMAT NovationDR, the first system to merge Siemens’ long-standing networking expertise with all the advantages of full-field digital mammography to optimize clinical workflow.

The MAMMOMAT NovationDR is designed to handle the mammography workup from patient registration and image acquisition to post-processing and reading. The system features Siemens’ exclusive dual anode technology. This tube offers three anode/filter combinations that match breast density and thickness – Mo/Mo, Mo/Rh, and W/Rh. With Tungsten technology and high mA output, even dense breasts are examined with shorter exposure times. Dose can be reduced by up to 50 percent, while maintaining image quality.

source: Siemens Medical

MR Applications - Innovations For Women's Health With The Magnetom Espree - Pink, The New Dedicated MR Breast Scanner

Siemens Healthcare exhibits its latest solutions in the field of Magnetic Resonance (MR) for Oncology at the European Radiology Congress ECR 2009 in Vienna. The syngo TimCT Oncology application enables not only comprehensive patient examinations within an extreme short examination time, it can also eliminate the need for multiple examinations with other modalities. The syngo Tissue 4D software supports tissue differentiation of prostate cancer. In addition, Siemens presents innovative technologies in the area of Women's Health: dedicated breast coils for 1.5 Tesla (T) and 3 Tesla systems as well as the new breast scanner Magnetom Espree - Pink. The 1.5T system combines a 70cm Open-Bore design with a dedicated breast care solution. Specifically designed for obese and claustrophobic patients, the large bore makes examinations more comfortable than with previous systems, or, in some cases, it makes them possible for the first time ever. Supplementary software packages such as syngo Grace allow for the biochemical detection of lesions that go beyond imaging.

source: Medical News Today

Research and Markets: Alarming Rise in Obesity-related Cancer Cases Spurs Growth in the North American Breast Imaging Markets

(live-PR.com) - DUBLIN, Ireland (Research and Markets) - Research and Markets (www.researchandmarkets.com/research/e3c1d7/north ..) has announced the addition of Frost & Sullivan's new report "North American Breast Imaging Markets" to their offering.

This study identifies technology trends, forecasts future changes in market measurements, and discusses specific challenges facing industry participants and strategic recommendations targeted to overcome these challenges for the North American Breast Imaging Market. The major geographic division covered is North America (including the United States and Canada).

Market Overview
The total North American breast imaging equipment market has seen considerable growth since 2006. One of the contributing factors is the alarming rise in the obese patient population. As studies have confirmed the connection between obesity and cancer, obese postmenopausal women have an augmented risk for breast cancer, and mammography procedural volumes in North America are set to escalate. Considering the age-associated characteristic of malignancy, screening of elderly women is imperative for early diagnosis and evaluation. Imaging and diagnostic procedures are steadily gaining importance as early detection dramatically improves survival rates.

source Live PR

Siemens Sets A New Standard For Breast Ultrasound

New automated breast ultrasound system automatically acquires volumes and offers intelligent clinical applications. Siemens Healthcare recently introduced the Acuson S2000 Automated Breast Volume Scanner (ABVS), the first multi-use ultrasound breast system that automatically acquires volume images of the breast. Thanks to the user-independent, standardized image acquisition, the system is ideally suited for early detection and diagnosis of breast cancer with ultrasound - especially for women with dense breast tissue.

According to the New England Journal of Medicine1, dense breast tissue increases the risk of breast cancer for a woman up to five-fold. While mammography remains the method of choice in breast cancer screening, a study published by the RSNA (Radiological Society of North America) in 20022 showed that the detection rate for non-palpable, invasive breast cancer increased by 42 percent when mammography was followed by an ultrasound examination.

source: Medical News Today

Breast-Specific Gamma Imaging (BSGI) Uncovers Additional Breast Cancer in Newly Diagnosed Breast Cancer Patients

NEWPORT NEWS, Va., Feb. 27 /PRNewswire/ -- Women facing a recent breast cancer diagnosis may find additional cancer in the same or opposite breast with further testing using Breast-Specific Gamma Imaging (BSGI) according to a study published in the February 2009 "American Journal of Surgery." BSGI detected additional or more extensive breast cancer in the same or opposite breast in 10.9 percent of newly diagnosed patients according to the study.

BSGI, a molecular breast imaging technique, is a follow-up to mammography that can see lesions independent of tissue density and discover early stage cancers. With BSGI, the patient receives a pharmaceutical tracing agent that is absorbed by all the cells in the body. Due to their increased rate of metabolic activity, cancerous cells in the breast absorb a greater amount of the tracing agent than normal, healthy cells and generally appear as "hot spots" on the BSGI image. The Dilon 6800 Gamma Camera is a high-resolution, compact field-of-view gamma camera, optimized to perform BSGI.

source: PR Newswire

Innovation For Women's Health - The New MRI Breast Scanner From Siemens

Siemens Healthcare recently presented its first MRI breast scanner, Magnetom Espree-Pink. This 1.5-Tesla system is the latest innovation in magnetic resonance imaging (MRI) from Siemens, featuring a dedicated solution for breast examinations. Particularly for obese and claustrophobic patients, the large, 70-centimeter magnet bore makes examinations more comfortable than with previous systems, or, in some cases, it makes them possible for the first time ever. The flexible design of the "Sentinelle Vanguard for Siemens" breast coil also optimizes the clinical workflow. Comprehensive applications, such as syngo Grace or syngo Views, additionally set a new standard in Women's Health.

source: Medical News Today

CAD With Full-Field Digital Mammography Shows High Sensitivity In Assisting Radiologists To Detect Early-Stage Breast Cancers

iCAD, Inc. (Nasdaq: ICAD), an industry leading provider of advanced image analysis and workflow solutions for the early identification of cancer, today announced publication of peer-reviewed data on its SecondLook Computer-Aided Detection (CAD) technology in the February issue of the American Journal of Roentgenology (Volume 192, Issue 2). The study, by Juliette The, MD and Kathy Schilling, MD included 123 cancers detected with full-field digital mammography (FFDM).

The article, titled “Detection of Breast Cancer with Full-Field Digital Mammography and Computer-Aided Detection,” found the following:

· CAD with FFDM showed a high sensitivity in identifying cancers

· The SecondLook CAD correctly marked 94% of biopsy-proven cancers

· The sensitivity of iCAD’s SecondLook CAD was not dependent on the size of the tumor; it was equally accurate with small and large lesions

“Our experience with the SecondLook CAD has been quite positive,” said Dr. Juliette The, Radiologist at Boca RatonCommunityHospital in Boca Raton, FL. “I am pleased with its ease-of-use and ability to help radiologists find more cancers, at an earlier stage. Coupled with full-field digital mammography, which has been shown to be more accurate in certain populations of women, we feel that CAD is an important tool that highlights the areas of a mammogram warranting closer inspection.”

source: iCAD Press Release

Frost & Sullivan Names Naviscan a Leader in the Future of Molecular Breast Imaging

MOUNTAIN VIEW, Calif., Feb. 19 /PRNewswire/ -- Based on its recent analysis of the medical imaging market, Frost & Sullivan presents Naviscan, Inc. with the 2009 North American Frost & Sullivan Award for Emerging Technology of the Year. The Award recognizes the company's impressive progress in developing to market a next-generation, breast-specific PET scanner and adjunct biopsy guidance system that is set to redefine the standard of care for breast cancer patients.

Naviscan distinguished itself in 2008 as the only company to commercially offer a Positron Emission Mammography (PEM) imaging scanner as well as an adjunct PEM-guided biopsy accessory. As the market and technology leader in molecular breast imaging (MBI), the company's promising technology continues to garner the attention of some of the nation's leading women's imaging facilities, including Manhattan Diagnostic Radiology, a practice that was recently recognized as a Breast Imaging Center of Excellence by the American College of Radiology.

"MBI has rapidly created a sizeable niche market for itself as a proven adjunct technology to traditional, full-field digital mammography (FFDM)," says Frost & Sullivan Industry Analyst Travis Chong. "To capitalize on the upward trend of an aging female population with dense breast tissue and other high-risk factors, a growing number of women's imaging centers are turning to MBI, in particular PEM, in recognition of the modality's added clinical value and favorable Medicare/Medicaid and private payor reimbursement."

source; PR Newswire

Sentinelle Medical Enters OEM Distribution Agreement with Siemens AG

TORONTO, Feb. 17 /PRNewswire/ - Sentinelle Medical Inc., a leading manufacturer of breast MRI coils and software and Siemens Healthcare today announced an OEM Distribution Agreement for Sentinelle's Vanguard(R) coils. Under this agreement, Siemens will sell the "Sentinelle Vanguard for Siemens" coil for the MRI family members MAGNETOM(R) Espree, MAGNETOM(R) Avanto and MAGNETOM(R) Symphony, A Tim(TM) System. The Sentinelle Vanguard for Siemens is also integrated into the new MAGNETOM Espree - Pink, a dedicated system devoted to excellence in MR Breast Care. The Agreement also anticipates future development collaborations.

Breast cancer is the most frequently diagnosed cancer in women. In 2008, 182,460 new cases were diagnosed and 40,480 women died of breast cancer in the US(1). The National Cancer Institute estimates that a woman has a 1-in-8 chance of developing breast cancer during her lifetime. The American Cancer Society's new screening guidelines will impact up to one million high-risk women by recommending they receive additional annual MRI screenings. A high percentage of these women will benefit from breast MRI.

The Sentinelle Vanguard for Siemens enables excellent quality MR images of the breast and provides complete and open access for intervention with an award winning design that optimizes patient comfort and workflow.

source: PR Newswire

New guidelines emphasize use of breast MRI to supplement standard imaging

SEATTLE – Updated guidelines for physicians that represent best practices for using magnetic resonance imaging (MRI) to newly diagnose breast cancer and to make treatment decisions for breast cancer were published today in the Journal of the National Comprehensive Cancer Network. Breast radiologists and surgeons at the Seattle Cancer Care Alliance (SCCA) and the Roswell Park Cancer Institute in Buffalo, N.Y. authored the paper upon which the guidelines are based.

The SCCA breast imaging program led by Connie Lehman, M.D., has established itself as a national leader in breast MRI based on pioneering research it has published in the past few years. Lehman is corresponding author of today's journal paper, "Indications for Breast MRI in the Patient with Newly Diagnosed Breast Cancer." The study summarizes an extensive review of published, peer-reviewed studies.

Among the key recommendations:

* MRI is not a substitute for screening or diagnostic mammography and, when indicated, diagnostic breast ultrasound. MRI supplements the use of these standard imaging tools in appropriately selected clinical situations.
* For women with diagnosed breast cancer, MRI provides enhanced detection in both the breast known to have cancer and the opposite, or "contralateral," breast.
* Surgical decisions should not be based solely on MRI findings because not all suspicious lesions on MRI are cancer. Suspicious lesions should be biopsied before a surgery plan is devised in order to avoid surgical overtreatment.
* In the rare instances where cancer is found in the lymph nodes but not the breast, an MRI can find the location of cancer in the breast in nearly 60 percent of women.

source: EurekAlert

Medipattern(R) Launches New B-CAD-For-Life(TM)

The Medipattern Corporation (TSX VENTURE:MKI - News), a pioneer in the development of medical software solutions that help improve imaging workflow and productivity, announces its new sales model for accessing the benefits of B-CAD. The new model offers all of the separate components that are required to install, train, use and maintain B-CAD as one package under one monthly service fee. Medipattern is effectively managing the service of providing computer aided detection (CAD) for breast ultrasound imaging for its customers with the B-CAD-FOR-LIFE(TM) plan.

"We first spotted B-CAD for the benefits that it could offer our practice early last year, but we are a small business on a tight budget," stated Olga Tsireshkin, MD founder of XXI Century Radiology and Imaging, P. C. located in Brooklyn, New York. "With B-CAD-FOR-LIFE, Medipattern still owns its asset, B-CAD; installs it, trains our staff in how to use it and maintains it for a monthly fee. This can give XXI Century immediate access to all of the benefits of B-CAD: saving time in documenting each case, improving communication of detailed information, that CAD second opinion, and reimbursement for the procedure in an affordable package.

source: YahooFinance (press release)

Dilon Technologies Leads Molecular Breast Imaging Expansion

NEWPORT NEWS, Va., Feb. 10 /PRNewswire/ -- Dilon Technologies, Inc., a leader in molecular breast imaging, today announced record sales for 2008 highlighted by the strongest fourth quarter in the company's history. The company achieved a 35 percent increase in sales from 2007 to 2008 as molecular breast imaging gains nationwide exposure and acceptance.

Breast-Specific Gamma Imaging (BSGI) - a molecular imaging procedure, along with breast MRI, are expected to increase at a compound growth rate of 28 percent over the next five years, according to the Millennium Research Group's U.S. Markets for Women's Health Imaging Systems report. It also states that Dilon Technologies is leading the way to global availability of molecular breast imaging. Dilon's cornerstone product, the Dilon 6800 Gamma Camera is a high-resolution, compact gamma camera optimized to perform BSGI.

"We had a particularly strong finish to the year, breaking through a monthly sales record in December," said Bob Moussa, President and CEO of Dilon Technologies. "Breast imaging centers across the country and around the world are using BSGI to pave the way to effective diagnosis of breast cancer."

source: PR Newswire

Radiologists Overestimate Their Overall Risk of Malpractice Lawsuits in Breast Imaging

Radiologists who work in breast imaging tend to overestimate their actual risk of medical malpractice lawsuits, according to a study performed at the University of Washington School of Public Health and Community Medicine in Seattle, WA.

The study included two separate surveys, one in 2002 and one in 2006 that asked radiologists in diverse regions of the US two questions: Have you ever had a previous malpractice claim related to mammography? And what do you think is your future probability of being sued in the next five years? Results showed that “the radiologist’s median estimate for the likelihood of being sued was four times higher than their actual risk,” said Joann G. Elmore, MD, lead author of the study. In 2002, a radiologist’s perceived risk of being sued in the next five years was 41% and in 2006 was 35%. The actual percentage of radiologists who reported malpractice claims five years prior to 2002 was 8% and the actual percentage of radiologists who reported malpractice claims five years prior to the 2006 survey was 10%. “Their perception of risk is much higher than the reported reality,” she said.

source: ARRS

Mammography missed high proportion of breast cancer in Mexican-American women

Data from the ongoing multicenter Ella Binational Breast Cancer Study suggest that despite a high rate of mammography screening reported by Mexican-American women a high percentage of breast cancer is not being detected using this method.

The data were presented yesterday at a press conference at the AACR 2009 Science of Cancer Health Disparities meeting.

Researchers from the University of Arizona Cancer Center in Tucson and The University of Texas M.D. Anderson Cancer Center in Houston used data from the U.S. population of the study to assess the relationship between education level, acculturation and breast cancer screening behaviors. The study included 230 women of Mexican descent with breast cancer. Study participants were aged 40 years or older and resided in Texas (n=138) or Arizona (n=92).

Data indicated self-detection was the most common method of breast cancer detection (67%), followed by mammography (23%), clinical examination (6%) or other methods (3%).

source: HemOnc today

Mammography Utilization in the United States Decreases: A State-Level Look

Nearly two thirds of the states in the US saw a small decrease in mammography utilization between the years 2000 and 2006, according to a study performed at the Centers for Disease Control and Prevention (CDC) in Atlanta, GA.

Data showed that although mammography use in 17 states including Minnesota, Tennessee, Georgia and Alabama had increased slightly between 2002 and 2006, mammography use in 34 states and the District of Columbia including Utah, South Carolina, New Mexico and Delaware had a slight decrease. The decrease in utilization ranged from -0.3% to -5.3%. The CDC also reviewed incidence rates and found that between 2000 and 2004 all but one state (Tennessee) had a decrease in breast cancer incidence rates. There was no clear pattern among the states though in regards to region, average age, average income or population density.

“The Government Accountability Office reported that there was a 6% decrease in mammography facilities use across the US, but despite their report there is a growing concern that this rate in low resource areas could be higher,” said Jacqueline Miller, MD, lead author of the study.

source: ARRS

New Technique Predicts Breast Cancer Chemtherapy Effectiveness

Atlanta (February 2, 2009) —Chemotherapy is an integral part of modern cancer treatment, but it’s not always effective. Successful chemotherapy depends on the ability of anticancer drugs to escape from the bloodstream through the leaky blood vessels that often surround tumors.

Predicting chemotherapy’s efficacy could save thousands of individuals from unnecessary toxicity and the often difficult side effects of the treatments

In a study published in the February issue of the journal Radiology, researchers describe a technique for determining the “leakiness” of tumor blood vessels using a simple digital mammography unit. The researchers designed nanometer-sized capsules containing a contrast agent that could only leak into tumors with blood vessels that were growing and therefore leaky. The digital mammography-based quantification of “leakiness” is closely correlated to the ability of a clinically approved chemotherapy agent to enter the tumor, allowing the researchers to predict the agent’s therapeutic efficacy.

source: Georgia Institute of Technology (News Release)

At NCBC, DR Systems to Exhibit Market-Leading Integration of PACS with Digital Mammography

DR Systems will exhibit its market-leading integration of PACS and digital mammography, during the upcoming National Consortium of Breast Centers’ (NCBC) 19th annual conference.

DR Systems will be in Booth 53 during the conference, which runs from Mar. 15-18 at Planet Hollywood, in Las Vegas.

The breast imaging, reporting and tracking functions of DR Systems’ Unity™ RIS/PACS are now successfully operating at 30 customer sites. The system is providing a comprehensive solution for full-field digital mammography (FFDM), third-party CAD, breast MRI and ultrasound, and breast reporting with automated regulatory compliance, including MQSA.

Exams from all modalities, including digitized prior film-based mammograms, can be read and compared on the same workstation. The system is designed to support all imaging and information from the Unity System.

This approach avoids many problems encountered by early adopters of FFDM that purchased dedicated standalone workstations. These facilities have discovered their setup has compounded inefficiencies by creating isolated islands of information separate from their PACS infrastructure.

press release: DR Systems

An Individualized Approach to Breast Cancer Treatment

Not all breast cancers are the same, and not all will have fatal consequences. But because clinicians find it difficult to accurately determine which tumors will metastasize, many patients do not receive the therapy fits their disease.

Tel Aviv University has now refined breast cancer identification so that each course of treatment is as individual as the woman being treated.

The new approach -- based on a combination of MRI and ultrasound -- is able to measure the metabolism rates of cancer cells. The approach helps determine at an earlier stage than ever before which cells are metastasizing, and how they should be treated.

The method, expected to start clinical trials in 2010, is currently being researched in Israel hospitals.

source: Tel Aviv University

Cutting-edge cancer technology comes to Ontario

CTV.ca News Staff

A major worldwide healthcare technology developer has chosen to test out some cutting-edge breast cancer detection technology on patients receiving care at an Ontario hospital.

It was announced Friday morning that GE Healthcare will test various molecular breast imaging probe prototypes at Henderson General Hospital in Hamilton, about 70 kilometres outside of Toronto.

The technology the company will be testing seeks to detect small tumours in women's breasts that are not found as easily through conventional mammography. The goal is to locate such tumours in their very earliest stages, so that treatment can be administered to patients as early as possible.

source: CTV.ca

Siemens, U-Systems Announce Licensing Agreement on Automated Breast Ultrasound Workstation

Mountain View, Calif., January 16, 2009 – Siemens Healthcare and U-Systems, Inc., today announced a technology licensing agreement for U-Systems’ somo•VIEWer™* advanced workstation for Automated Breast Ultrasound for use with Siemens’ ACUSON S2000™ Automated Breast Volume Scanner (ABVS), which recently received FDA 510 (k) clearance. This will allow physicians to obtain the comprehensive 3D view of the breast with the intuitive anatomical coronal plane not available with conventional ultrasound systems. The agreement will facilitate the adoption of Automated Breast Volume Ultrasound for women’s healthcare providers.

ABVS can make a significant contribution in diagnostic confidence for women with dense breast tissue and inconclusive mammograms. The coronal view provided by the somo•VIEWer workstation offers a more understandable representation of the global anatomy and architecture of the breast, which will ultimately improve patient care and increase clinical workflow.

source: Siemens Medical

Carestream Health Installs 2000th CR System With Digital Mammography Feature

ROCHESTER, N.Y., Jan. 15 — Carestream Health, Inc., installed its two thousandth high-resolution CR system for mammography at the Rechts der Isar Clinic in Munich, Germany.

CR EliteThe company’s KODAK DIRECTVIEW CR Mammography Feature—which enables mammography images to be captured digitally while utilizing a healthcare provider’s existing mammography x-ray unit and workflow processes—is intended for use in the same clinical and screening applications as traditional screen-film based mammography systems.

The Munich University Rechts der Isar Clinic, with its specialized team of physicians dedicated to mammography, installed a new multi-plate KODAK DIRECTVIEW CR 975 System with Mammography Feature in November. The clinic is part of the Institute for X-ray Diagnosis of the University of Munich, which performs more than 100,000 medical procedures each year and features a fully digital environment.

source: Carestream Health

FDA Scientists Request Investigation Into Agency Approval Of Breast Imaging Device

Scientists at FDA have requested that Congress and President-elect Obama investigate their allegations that an FDA official approved the sale of a breast cancer imaging device over the objections of the front-line scientists after receiving a phone call from a Connecticut congressman, according to the New York Times. The Times reports that the call from the congressman and its "effect on what is supposed to be a science-based approval process" represent "only one of many accusations in a trove of documents" the newspaper received regarding disputes within the FDA Office of Device Evaluation.

According to the Times, the documents show through e-mail correspondence that top agency scientists allege that an agency supervisor inappropriately forced them to modify reviews of the iCAD SecondLook Digital Computer-Aided Detection System for Mammography -- a computer device to assist in the detection of breast tumors -- after former Rep. Christopher Shays (R-Conn.) called an agency supervisor a few years ago to voice concerns about the future of the device. According to the Times, the device is used with screening equipment made by Fujifilm Medical Systems, which is based in Shays' former district. According to the FDA documents, the nine scientists involved with the iCAD decision said that the company "never tested the device by the intended users (i.e. radiologists) under the intended conditions of use. This is the most basic and fundamental requirement of all FDA submissions." The risks of iCAD include missed cancers, "unnecessary biopsy or even surgery (by placing false positive marks) and unnecessary additional radiation," according to an internal review.

source: Medical News Today

iCAD announces availability of its SecondLook Digital with Planmed Nuance Full Field Digital Mammography Systems outside of U.S.

iCAD®, Inc. (Nasdaq: ICAD), an industry-leading provider of Computer-Aided Detection (CAD) solutions, today announced that its SecondLook® Digital CAD technology customized for use with the Planmed Nuance FFDM system is now available outside of the U.S.

"When analyzing iCAD´s SecondLook Digital CAD with Planmed Nuance Full Field Digital Mammography unit using selenium flat panel detector, it was found
that the true positive findings detected at double reading of screening mammograms, were also marked accurately by CAD," said Dr. Martti Pamilo from Terveystalo, the leading private healthcare provider in Finland.

"We are excited to see the results of the iCAD´s SecondLook Digital CAD integration to the Nuance FFDM system," said Vesa Mattila, Vice President of Planmed. "As CAD is becoming widely accepted in Europe, iCAD's technology is an important addition to Planmed's digital mammography systems and solutions."

source: PR-Inside

Interpretation Time for Screening Digital Mammograms: Is it Efficient?

Digital mammograms take longer to interpret than film-screen mammograms, according to a study performed at The University of Texas M.D. Anderson Cancer Center in Houston, Texas.

The study included four radiologists who interpreted 268 digital screening mammograms and 189 film-screening mammograms. “The average interpretation time for all of our readers was 240 seconds (4 minutes) for digital screening mammograms and 127 seconds (2 minutes, 7 seconds) for film-screen screening mammograms,” said Tamara Miner Haygood, MD, lead author of the study. “The digital screening mammograms took nearly twice as long to interpret as the film-screen screening mammograms,” said Dr. Haygood.

The study identified factors that might have contributed to the difference in time. “Those factors were the identity of the interpreting radiologist, whether there were older studies available for comparison, whether the radiologist looked for and hung up additional films, how many images were obtained and whether the study was normal or not. In each of these situations, the digital images took longer to interpret than the film-screen images,” said Dr. Haygood.

source: ARRS

ACS Guidelines for Breast Screening with MRI May Be Excluding Some High-risk Women

The American Cancer Society (ACS) has developed a set of guidelines to recommend which high-risk women need to undergo screening with breast magnetic resonance imaging (MRI); however, these guidelines may unwittingly exclude some women who are at a high risk of carrying the BRCA mutation yet still don’t meet the limitations set by the ACS. The results of this study were published in the journal Cancer.[1]

Breast cancer is the second leading cause of cancer death in women in the United States, with approximately 180,000 cases diagnosed each year. Women with a family history of breast cancer are at an increased lifetime risk of developing the disease, as are women who carry a BRCA mutation. These women are encouraged to undergo more vigilant screening to allow for earlier detection and higher cure rates.

source: cancerconsultants.org

Medicare Rebate for Breast MRI (Australia)

A Medicare rebate for an MRI breast scan will be available to women under 50 at high risk of breast cancer and with no symptoms from 1 February 2009.

Being at high risk of breast cancer can cause significant anxiety. These scans can help reduce unnecessary concern, and help pick up breast cancer early.

The Australian Government is reducing the financial barrier of the cost of a Magnetic Resonance Imaging (MRI) scan to encourage these women in the high risk category to monitor their health.

Women at high risk of breast cancer include, for example, women with three or more close blood relatives diagnosed with breast or ovarian cancer.

Further details about the women eligible for this Medicare rebate will be available from 1 February 2009 on MBSonline at www.health.gov.au

source: Australian Givernment Dept.of Health