|Study: Combining various MRI techniques might help improve breast cancer detection|
|Researchers at Johns Hopkins (Baltimore, Md) say that combining various types of MRI techniques can more accurately sort cancers from benign masses in breast tissues than any single imaging technique.
The study found that MRI scanners could be calibrated to take images that highlight a specific type of human tissue. For example, T1-weighted sequences best show fluids, like those found inside cysts. Additionally, 3-D MRI can help define the size and shape of tumors.
In the study, Johns Hopkins researchers combined T1, T2, and 3-D imaging techniques, with and without contrast agents, on 36 subjects. Eighteen subjects already had been diagnosed with benign breast lesions, and 18 with breast cancer. The researchers reviewed the results of the combined images without knowing which images came from which patient. The combined, or multiparametric MRI technique, was able to identify and characterize breast lesion tissue cluster in all 36 patients, revealing which were benign and which were malignant. In addition, the multiparametric technique was even more powerful when used with contrast agents, providing more precise differentiation between the cancerous and noncancerous tissue than the same images without contrast.
Each individual imaging modality has its advantages, said Michael Jacobs, PhD, lead researcher for the study at the Johns Hopkins Department of Radiology. When all these techniques are combined into one data set, you can achieve an approach that shows the characteristics of a lesion not normally available using just one imaging technique.
Jacobs notes that although his study appears to demonstrate the feasibility of using a combined imaging approach to identify breast tumors, larger studies are needed to determine if the approach might be useful for studying the molecular dynamics of breast cancer tumors.
|Palatin files BLA amendment with FDA|
|Mallinckrodt, a business unit of Tyco Healthcare (St Louis), released a statement announcing that its strategic collaboration partner, Palatin Technologies (Cranbury, NJ), has filed a biologic license application with the FDA for LeuTech, a new radiopharmaceutical for imaging infection sites. The submitted amendment, which addresses the additional manufacturing and process validation data requested by the FDA, starts the review process. A complete response and market approval from the FDA is anticipated in the first half of 2004.
In July 2000, the Medical Imaging Drug Advisory Committee (MIDAC) of the FDA unanimously determined that LeuTech is safe and effective for use in the diagnosis of appendicitis in patients with equivocal signs and symptoms. MIDAC also concluded that the data supports the clinical utility of LeuTech in facilitating the management of these patients.
Of the 500,000 patients with suspected appendicitis, about half will have clinical findings that are atypical, explained Dr Frederick Weiland of the Sutter Health Organization (Sacramento, Calif) There are many causes of abdominal pain, and it can be difficult to differentiate appendicitis from other causes. In addition, other noninvasive tests to diagnose appendicitis, such as spiral CT with contrast, are not available everywhere and can be difficult to perform and interpret. If a diagnosis of appendicitis is missed, there can be significant medical consequences, such as perforation and peritonitis. Because of the risk, it is currently acceptable to have a 10% to 20% negative laparotomy rate in which a normal appendix is removed.
LeuTech (Technetium Tc-99m Anti-CD15 Antibody) is a radiolabeled monoclonal antibody used for detection of infection of the appendix. The labeled antibody binds to white blood cells that collect at the site of an infection, and a picture is taken of the site using a gamma camera in the nuclear medicine department. The combination of using the antibody with the gamma camera allows the physician to quickly locate the site of infection. Using LeuTech, 90% of appendicitis cases can be confirmed within 1 hour of injection, thus providing rapid diagnosis without the time delays and risks associated with current white blood cell labeling procedures.
According to Palatin, clinical evidence shows that the potential for LeuTech extends well beyond equivocal appendicitis. Additional phase-two studies with LeuTech currently are being conducted for the imaging and detection of other infections, such as osteomyelitis, fever of unknown origin, postsurgical abscess, and inflammatory bowel disease.
Mallinckrodt and Palatin entered into an agreement in 1999 for Mallinckrodt to exclusively market and distribute LeuTech throughout the world, except in Europe. Upon FDA clearance, Mallinckrodt will begin marketing and distribution of LeuTech through its St Louis distribution center and network of US radiopharmacies.
|AHRQ awards millions in challenge grants to help hospitals improve safety|
|The Agency for Healthcare Research and Quality (AHRQ of Rockville, Md) awarded almost $4 million to fund 13 projects designed to improve patient safety in hospitals. Six of the grants will asses patient safety risks and devise ways to prevent them; the remaining seven will implement safe practices that show evidence of eliminating or reducing known hazards to patient.
These grants not only will help hospitals put proven remedies in place to reduce errors, but also will provide a wealth of information on where risks still occur and what can be done to eliminate them, said Tommy Thompson, health and human services secretary for AHRQ. Efforts like these will help hospitals, and other parts of the healthcare system, make meaningful progress to improve the quality of care for patients.
The 13 grants build on the AHRQs 3-year, $165-million investment in patient safety research. We see these challenge grants as an exciting opportunity to provide hospitals with the resources to identify and confront the causes of medical errors, said AHRQ Director Carolyn Clancy, MD. The findings of this research will help us reach our ultimate goal of ensuring that Americans receive high-quality, safe healthcare.
|Highest attendance in 35 years at Medica 2003|
|MEDICA 2003, the 35th World Forum for Medicine, closed to record results: 134,700 visitors (compared with 132,500 at MEDICA 2002) and 3,906 exhibitors (compared with 3,648 exhibitors last year) from 65 countries. Held November 1923, MEDICA 2003 showcased the spectrum of inpatient and outpatient care in 1.2 million square feet of exhibition space at the fairgrounds in D?sseldorf, Germany.
According to the host organization, Messe D?sseldorf, every third visitor came from outside of Germany, and 62% of the exhibitions were from countries other than Germany (a 3% increase compared to MEDICA 2002). With 322 companies, the United States was, again, the leading foreign exhibitor nation, followed by Italy, Great Britain, France, and China.
The MEDICA Congress and the 26th German Hospital Conference supported the exhibits at MEDICA. In seminar and symposia sessions, the MEDICA Congress dealt with such issues as new trends in cardiology, molecular oncology, and minimally invasive surgery techniques.
|ATCT now accepting applications for membership|
|The Academy of Transcatheter Cardiovascular Therapeutics (ATCT) is now accepting applications for membership from qualified interventional cardiologists, radiologists, and other specialists in vascular medicine. The goal of ATCT, a global organization with international representation, is to promote research and education in vascular intervention. Benefits of membership include downloadable slide sets, clinical investigator sponsorship, participation in an e-PCI registry, career achievement recognition, proficiency evaluation for interventional procedures (in collaboration with the Society of Cardiovascular Angiography and Interventions), and discounts to TCT and other meetings.
The ATCT welcomes participation from professionals and would like to be notified about possible membership benefit ideas. For more information, a membership application, and a downloadable brochure, visit www.tctmd.com.
|Study: PET technique offers greater comfort to cancer patients|
|German researchers conducted a study to determine if dynamic PET provides useful data when taken over a shorter period than the traditional 1-hour scan. The study revealed the shorter scan can provide an accurate diagnosis, not only decreasing false positive results and predicting patient response to chemotherapy, but also providing for a more comfortable diagnostic experience.
The results of the German study revealed that a 10-minute dynamic scan taken immediately after tracer injection, coupled with a static scan 5660 minutes after injection, provided statistically accurate information about F-FDG influx, VB, k1, and SUV. A comprehensive analysis of 151 data sets from patients with a variety of cancers allowed researchers to make this conclusion.
According to the researchers, Our goal was to delineate a procedure that provides more information than a static scan while also employing a wise use of resources. Less time spent in the PET scanner is more comfortable for patients, and from the perspective of the nuclear medicine practitioner, this procedure could also save both time and money.
The research document, Shortened PET Data Acquisition Protocol for the Quantification of 18F-FDG Kinetics, was written by Ludwig G. Strauss, MD, Antonia Dimitrakopoulou-Strauss, MD, and Uwe Haberkorn, MDall from the Medical PET Group, Biological Imaging, Clinical Cooperation Unit Nuclear Medicine, German Cancer Research Center in Heidelberg, Germany.
|MaxxVision and NHD announce distribution and services agreement|
|Two imaging companies recently announced a business contract: MaxxVision (Gainsville, Fla) and National Healthcare Distribution (NHD of Beachwood, Ohio). Under the terms of the agreement, NHD will distribute iView, a digital imaging system, to the US mammography market.
MaxxVisions iView is a lightweight, portable, hand-held imaging device for use in film mammography that harnesses the power of digital enhancement and enables the human eye to perceive small, subtle features on film images that might be missed.
iView is one of the most exciting, helpful, and affordable mammography products Ive seen, said Randy Robinson, president of Radiology Imaging Solutions Inc (Grand Rapids, Mich). Because of its price, [the iView] is targeted at the lower-volume channel with which NHD has long-established relationships.
|OSI Systems to acquire Spacelabs Medical|
|OSI Systems Inc (Hawthorne, Calif) has signed an agreement to purchase Spacelabs Medical (Issaquah, Wash) for approximately $57 million in cash.
Spacelabs is a unit of Instrumentarium Corp, which GE Medical Systems (GEMS of Waukesha, Wis) acquired in October 2003. To complete the acquisition of Instrumentarium, GEMS agreed with required regulatory agencies to divest Spacelabs business worldwide. In addition, GEMS committed to provide the acquirer of Spacelabs with the rights to distribute and market certain GEMS products and accessories.
Spacelabs 2003 unaudited revenues are estimated to be approximately $150 million; its unaudited tangible net assets have a book value in excess of $70 million. Spacelabs will operate as a wholly owned subsidiary of OSI Systems and maintain its own presence, similar to other existing OSI subsidiaries, such as Dolphin Medical Inc and Osteometer MediTech Inc. Spacelabs will continue to be managed by Richard Atkin, who will serve as the president of the new subsidiary. Key individuals in the Spacelabs management team are being retained by OSI Systems as part of the transaction.
Diversification and vertical integration have always formed the cornerstone of our business philosophy, said Deepak Chopra, chairman and CEO of OSI Systems. Spacelabs represents an attractive opportunity for us to build a larger presence in our identified target end-product market of medical monitoring systems. By adding a successful and innovative company like Spacelabs to our organization, we are able to significantly strengthen our presence in medical monitoring.
|Barco and Toyo to develop co-ownership of new company|
|Barco (Kortrijk, Belgium) and Toyo (Tokyo) announced the setup of a joint venture company in Japan. Barco and Toyo will each own 50% of the shares of the newly formed company, which will be called Barco-Toyo Medical Systems Japan Co Ltd.
The cooperation between the two companies is due to Toyos thorough knowledge of the needs and demands of the Japanese medical modality OEM market and Barcos experience in providing display technology for medical modality applications.
Barco and Toyo plan to combine their expertise in order to provide customized
solutions for the growing Japanese medical-imaging market. The new company will be based at the Toyo headquarters in Tokyo.
|HR Simon first in X-ray chemical industry to be ISO 9001:2000 certified|
|HR Simon & Co Inc (Baltimore) became the only independent X-ray chemical manufacturer to achieve the 9001:2000 certification by NSF-ISR and independent ANSI-RAB accredited registrar. The company received the certification for its quality management system.
According to Jason Simon, VP and general manager of HR Simon, This ISO 9001 certification attests to our commitment to quality design and manufacture of formulas for X-ray developer, fixer, related solutions, and automatic mixing solutions.
|Study: Can CT scans predict coronary risk?|
|Going to the mall to have your coronary arteries scanned for calcium doesnt seem logical, but an increasing number of Americans are having the procedure performed in such places as church basements, mobile tractor-trailer units, and, yes, shopping malls.
The recent controversy surrounding the test is not because of its communal locations. Instead, the medical community is divided over the recent claim that CT scans for calcium deposits can play a significant role in predicting cardiac deaths and making treatment decisions for those who are in the middle-range of coronary risk. Individuals in the middle range have a known risk of heart attack or cardiac death, which, using a standard risk-assessment method, is calculated at 10% to 19% over 10 years.
Research shows that the scans are not a predictor of high-risk patientsthose with high cholesterol, diabetes, or who smoke heavilynor is the test useful for people whose risk is minimal. But, for those individuals in the middle-range (about 40% of adults), the CT imaging tests are being considered a significant avenue for early detection of congested arteries. These findings were conducted at Northwestern Universitys Feinberg School of Medicine in Chicago, the University of California at Los Angeles, and the University of Southern California.
The research involving CT scans for calcium is an attempt to enable doctors to make faster and more aggressive diagnosis and treatment for those of middle risk. If a large amount of coronary calcium is found earlier, doctors have more time to prescribe drugs or advise the patient on lifestyle changes.
Statistics show that 35% of heart attacks occur in those with cholesterol measures that are below the accepted standard of 200. When performing the study, researchers focused on whether the imaging test could help improve the risk factor for those in the middle range. The study found that the results of the CT scans do alter the risk factor and can lead to earlier and more intensive treatment.
Although the results of the CT cholesterol scan are positive, only a specific amount of Americans at risk can benefit from the test. Researchers found that tests given to those over the age of 45 provided the best results simply because the lower the patients age, the lower his risk. Also, the scan will not influence those who are considered to be high risk or for those with diabetes.
Amid the debate of its actual relevance, the new research, if accepted by the medical community, could prove to be a blessing to manufactures of cholesterol-lowering statin drugs, such as Lipitor and Zocor. But it is the misunderstanding on the part of the patient and the possibility of overtreatment by some doctors that has sparked the debate over the CT scanning procedure. Many cardiologists believe that a healthy amount of calcium is needed to protect heart arteries. Based on this belief, many have questioned whether a high calcium score is a just classification of a high-risk patient. The question intensifies when considering middle-range patients.
|Premier awards CR contract to Fujifilm Medical|
|Premier Purchasing Partners (Oak Brook, Ill) has renewed its 3-year purchasing contract with Fujifilm Medical Systems USA (FMSU of Stamford, Conn). FMSU will continue to provide its line of cassette-based CR products to Premiers nearly 1,500 member hospitals. Agreed-upon products include CR readers, imaging plates, cassettes, and accessories. The contract between the two companies is effective through December 2006, and valued at approximately $85 million.
Led by the companys new XG5000, all of FMSUs cassette-based readers are named in the contract. The XG5000 can read and erase a storage-phosphor IP more efficiently than any other available CR reader. All of FMSUs CR readers, including the newly released ClearView-CS, are included in the contract as well.
Fuji is proud to offer the only complete line of technology-consistent solutions for digital X-ray, said Phil Buffington, executive director of national accounts at FMSU.
This contract is in addition to the medical film and imager contract that Premier awarded to FMSU last August.
|Siemens installs 10,000th ultrasound system worldwide|
|Siemens Medical Solutions (Malvern, Pa) has installed its 10,000th ACUSON Sequoia system at the University of California at San Francisco, bringing the medical centers total number of Sequoia systems to 13.
[We] purchased our first Sequoia system close to 8 years ago. We felt it was the platform against which many advancements in sonography would be made, said Roy Filly, MD, chief of the section of diagnostic ultrasound, professor of radiology, surgery, and obstetrics, gynecology and reproductive sciences, UCSF Medical Center.
The Sequoia platform, which was showcased at RSNA 2003, includes expansion of Siemens TEQ ultrasound technology. In addition to fully optimizing an image in 2-D, TEQ offers instant, one-button optimization for spectral Doppler imaging, and reduces the time spent optimizing image parameters during exams by up to 95%.
TEQ ultrasound technology for 2-D imaging and Spectral Doppler utilizes patient-specific information to compensate for patient-to-patient variables. Addition-ally, the Sequoia matches response technology measures and adapts, in real-time, to a patients individual acoustic properties for heightened clinical specificity.
According to Bill Carrano, VP of worldwide marketing for Siemens, the introduction of the ACUSON Sequoia platform has been recognized as the leading diagnostic ultrasound system with dramatic clinical advancements.
Carrano added, The fact that Dr. Fillys lab was the first to receive the new Sequoia platform in 1996and now, nearly 8 years later, his team is receiving our 10,000th unitspeaks clearly to the importance and longevity of this advanced technology.
|Hologic and Confirma partner to improve mammography|
|Hologic Inc (Bedford, Mass) and Confirma Inc (Kirkland, Wash) have announced plans to partner in order to provide the mammography market with new approaches for reading breast MRI studies. The new agreement gives Hologic nonexclusive distribution rights for CADstream, Confirmas CAD system that automates the processing of data-intensive breast MRI studies and assists radiologists with study interpretation. Also, Confirma is completing the integration of its CADstream-processed breast MRI studies and system to function with Hologics full-field digital LORAD Selenia system, which will provide simultaneous mammography and breast MRI study viewing capability. This ability to view a breast MRI study is a similar position (or plane) as a mammogram, and it should provide more detailed information in one review session.
The agreement with Confirma provides an excellent opportunity for us to make CADstreams technology available to our established market basemammography professionals in womens imaging centers and hospitals throughout the United States, said Jack W. Cumming, Hologics chairman and CEO. We believe radiologists will realize significant clinical and economic benefits using breast MRI with CADstreams automated image processing functions, including image registration.
Confirma launched CADstream, the first CAD application designed exclusively for breast MRI, in January 2003. The systems platform is initially applied to breast MRI, which is being used more widely for determining the extent of breast disease, evaluating surgical margins, and monitoring response to treatment. Breast MRI also is recommended by the American Cancer Society as an adjunct to mammography for patients known to be at risk for breast cancer, a population that could include up to 8.5 million women in the United States.
According to Hologic, as clinical indication and study numbers expand, the amount of data produced per breast MRI exam has increased tremendously, with exams often producing 800 images. Physicians and MRI technologists spend a significant amount of time manually processing and interpreting a breast MRI study. CADstream automates breast MR image
processing functions and corrects for patient movement that could occur during a study acquisition. The result for radiology clinics is standardization in processing and interpretation as well as enhancement of breast MRI study economics and quality control.
Cumming added, Putting better efficiency tools in the hands of healthcare professionals can enhance the interpretation of breast-imaging studies, ultimately resulting in improved patient care.
|Carstens redesigns product catalog|
|Carstens Inc (Chicago), a provider of medical charting systems, has redesigned its January 2004 product catalog with enhanced graphics, layouts, and other features to make locating and ordering specific items more efficient for purchasing department managers, administrators, and other professionals at hospitals and healthcare facilities.
The companys product line features more than 2,000 items. The new catalog contains simplified sections with such product categories as charting, divider sets, identification, chart storage, WALLaroo wall-mounted workstations, and Medix-Vistray systems. Step-by-step instructions help guide purchasers through the order process, from selecting styles, colors, and related options to creating customized products and systems that fit specific charting, storage, and privacy needs.
The new catalog, which hit mailboxes in December 2003, is also available online at www.carstens.com.
|Entela receives A2LA scope expansion|
|The American Association for Laboratory Accreditation (A2LA) accredited Entela Inc (Grand Rapids, Mich) for its ability to demonstrate the appropriate qualifications to produce technically valid test data and results in lighting products testing.
Entela has been accredited by A2LA for chemical and chemical testing (chemicals, metals, nonmetals, environmental testing, failure analysis, furniture testing, vibration/mechanical durability/fatigue, and electrical/electronics testing) for a range of applications and industries, including diagnostic imaging. The scope of accreditation has been expanded to include 10 types of Entelas lighting equipment and applications, such as the companys forward lighting devices, spectrophotometry, and photometry of retroreflective materials.
|Study: PET scans found to be superior to CTs|
|A recent study conducted by re-searchers at the University of Texas, Houstons MD Anderson Cancer Center found that F-FDG PET scans are more effective than CT scans for predicting response to imatinib mesylate, a drug that has recently been found effective in treating gastrointestinal stromal tumors (GISTs).
The results of the research conclude that PET scans allow doctors to determine if their therapy regimen is working very early in the treatment process. This information allows both physicians and patients to decide as soon as possible whether to continue treatment with imatinib mesylate or to try a different therapy.
Researchers conducted the retrospective analysis by examining the sensitivity and predictive values of PET and CT scans taken prior to therapy and then again 2 months after imatinib mesylate treatment had begun. Although no significant statistical difference exists between the pretreatment accuracy of the two different types of scans, PET was more effective in early assessment of the patients responses to the drug.
The paper, The Role of 18F-FDG PET in Staging and Early Prediction of Response to Therapy of Recurrent Gastrointestinal Stromal Tumors, was written by a group of MDs from the diagnostic radiology and biostatistics departments at Houstons MD Anderson Cancer Center.
|Electromed and Inphact merge complete|
|Evolved Digital Systems Inc (Laval, Quebec)formerly known as Electromed Inc and Inphact Inchas completed final requirements for the combination of the two companies. The operating name change for both companies became effective December 2003.
The newly formed organization is positioned as a leader of medical imaging information management solutions for both cardiology (Electromeds View products) and radiology (Inphacts RadWeb services). Evolved has a current installed client base of more than 130 locations in North America and Europe.
Evolved provides integrated, turnkey information systems solutions to its customers. The companys outsourced model enables healthcare facilities to focus on their core business: the delivery of quality patient care. By providing integrated imaging, workflow, and business office solutions, Evolved generates efficiencies within the radiology and cardiology departments.
|Carl Zeiss and 3I partner to distribute high-speed imaging system|
|Carl Zeiss MicroImaging (Thornwood, NY) and Intelligent Imaging Innovations (3I of Denver) announce the partnership of the two companies for the marketing and sales of the Stallion, a jointly developed imaging system in the United States and Canada.
View images with greater speed and higher definition with the collaborative technology of Carl Zeiss and Intelligent Imaging.
The new system is designed for high-speed imaging applications, including FRET, 4D, and ion ratio imaging employed in physiology, cell biology, and neuroscience research. The Stallion consists of a Zeiss motorized microscope, such as the Axioplan 2 IE, the Axioskop 2 upright, or the Axiovert 200 inverted. The system also features imaging software and synchronization hardware developed by 3I. The software includes high-sensitivity cameras, Photometrics Coolsnap HQ, piezoelectric focusing collar, rapid wavelength switching xenon light source, antivibration devices, and an optional environment maintenance chamber.
|On the Move|
RK Ltd (Racine, Wis) recently relocated its billing office to 1055 Prairie Dr, Suite D, Racine, WI 53406. The company is a full-service, HIPPA-compliant medical billing company specializing in radiology and pathology medical billing.
Array Corp US (Brentwood, NH) announced George Major as the companys director of support operations. Major joins Array with more than 25 years of experience in radiology sales and technical and product support.
Complementing its branches in Beijing, Shanghai, and Shenh-zen, Richardson Electronics (LaFox, Ill) recently announced the opening of a new branch office in Chengdu, China. The new office will further Richardsons ability to provide engineered solutions to its market segments within China.
Dr Jean-Marie Dupuy accepted a position on the Scientific Advisory Board for Vancouver-based ProtoKinetix Inc (PKRX). Dupuy is currently a consultant to several large pharmaceutical and biotech companies for project development, scientific advice, preclinical and clinical research, clinical trail implementation, and regulatory agency assistance in the United States, Canada, and Europe. He most recently served as medical director of Pasteur Merieux Connaught in France.
Jack Bailey, Marc Smith, PhD, and Gordon Sprenger have been appointed to the Board of Directors of Joint Commission Resources (JCR) (Oakbrook Terrace, Ill). Bailey is VP of B2B operations for Eli Lilly and Co. Smith is the president and CEO of the Missouri Hospital Association. And Sprenger served as the president and CEO of Allina Health System.
The American Society of Radiologic Technologists (ASRT) has selected Charles Barry Burns, MSPH, RT, to serve on the FDAs Radiological Devices Panel. Burns hails from the Department of Allied Health Professions at the University of North Carolina School of Medicine. He was nominated to the panel in June 2003 and will serve a term through January 2007. Burns first meeting is this month.