Diagnostic Imaging Scan - March 25, 2008 - (Page 2) will cost about €250 million ($393 million), is scheduled to begin operating in 2012. Its three treatment rooms, with an annual capacity of 3000 patients, will be complemented by a department for conventional radiation therapy, scheduled to open in 2011. Corporate moves on opposite sides of the U.S. are changing and expanding the reach of Radnet. The company, known as a long-time provider of imaging services, is extending its clinical reach in Southern California to offer comprehensive breast disease management. Combining recently acquired breast oncology and surgery businesses, Radnet’s new BreastLink division will specialize in the diagnosis and treatment of all forms of breast disease. Services will include imaging, interventions, genetic counseling, medical oncology, and surgery. Meanwhile, the company has acquired one of the largest and most established outpatient imaging practices in Delaware. This chain of practices, acquired from Papastavros’ Associates Medical Imaging, offers MRI and functional MRI, CT, PET, nuclear medicine, mammography, bone densitometry, fluoroscopy, ultrasound, and x-ray. Previously cleared by the FDA for accelerated therapy of early-stage breast cancer, Xoft’s Axxent Electronic Brachytherapy System can now be marketed to treat other cancers or conditions addressed by radiation therapy, thanks to an FDA extension of indications. The technology platform delivers localized isotope-free radiation treatment in minimally shielded clinical settings. When used against early-stage breast cancer, it reduces the time needed for externally applied therapy from seven weeks to five days. Despite an improved top line, losses mounted for Neoprobe last year. The company lost $5.1 million in 2007 compared with a net loss of $4.7 million the year earlier, although total revenues of $7.1 million were 18% higher than in 2006. In 4Q 07, Neoprobe reported a net loss of $1.9 million compared with a net loss of $1.3 million in the yearearlier period. Fourth quarter Inconsistencies haunt cardiac SPECT Quantitative measures differ among top software packages Significant differences can be found in the quantitative measures delivered by software commonly used to interpret cardiac SPECT scans, according to the findings of collaborative study among major medical centers. Most interpreters of cardiac SPECT use any of three software packages provided by vendors of gamma cameras and PACS— Quantitative Gated SPECT algorithm from Cedars-Sinai Medical Center, Emory Cardiac Tool Box from Emory University Hospital, and 4D-MSPECT from the University of Michigan Medical Center. The packages are all licensed from academic institutions. A collaborative study among the University of Oregon and Sacred Heart Medical Center in Eugene, as well as Cedars-Sinai Medical Center in Los Angeles, documented a lack of consistency among these three packages, leading the investigators to suggest that the same software be used to compare and analyze SPECT data acquired on individual patients at different times and in different laboratories. Although the research documented inconsistencies among these major software packages, there is relatively little danger of misdiagnosis due specifically to these shortcomings. Several sources of data factor into a diagnosis, including physical assessment of the patient during stress testing, such as the appearance of pain or blood pressure abnormalities; ECG recordings; and, in the case of SPECT, a visual analysis of the images. “Inconsistencies due to the software could lead to a misdiagnosis, but that would occur probably in a limited fraction of patients,” said Dr. Mathews Fish, medical director of nuclear cardiology at the Oregon Heart and Vascular Institute at Sacred Heart. Fish applauds the presentation of images by these packages, noting that at least 75% of the decision making based on SPECT is related to visual impression. Important management and treatment decisions, however, are based on quantitative analyses provided by the software, particularly when characterizing the degree of abnormality, Fish said. “One program might indicate a mild abnormality, and another might say it is more than that,” he said. Concerns about possible misdiagnosis are mitigated by using a single type of software. Familiarity with the quantitation in the context of other diagnostic data and use of the software on patients from one scan to the next make patient assessments easier and more accurate. All three types of software are widely available, Fish said. Vendors often have multiple licensing agreements for the different software packages, allowing an institution to choose whichever one it wants. Sometimes, several are made available to a customer, ensuring that a patient’s images analyzed with one package can be analyzed later with the same software. Also, certain software packages tend to dominate depending on the area of the country. Providers in the western U.S., for example, gravitate toward the algorithm developed by Cedars-Sinai. Future developments may also improve the underlying quantitation. As part of research sponsored by the National Institutes of Health, Fish and colleagues are developing an automated high-performance system for analyzing the data from cardiac SPECT exams. Their efforts have focused on different approaches for quantifying the data. “The goal is to make (the analysis) more objective, more quantitative, and more accurate,” he said. “We’re looking at a whole variety of things, so we might combine them so as to make a better determination of what is normal and what is abnormal.” This is going to take awhile, however. The research team is in the first year of a fiveyear grant. GE poises to reenter C-arm market pending FDA decision Diligence and compliance mark regulatory odyssey For more than a year, the x-ray surgical products arm of GE Healthcare lay dormant, the C-arm assembly lines quiet, their 135 workers transferred to other jobs pending the resolution of deficiencies found by FDA inspectors in GE’s current Good Manufacturing Practices (cGMP). Late last year, however, signs of life returned to the floor of this Salt Lake City plant. Production workers returned and x-ray C-arms began rolling again, not to the loading dock but into storage. The FDA had agreed to let the company start low-level production—at GE’s own risk. Copyright © 1991-2008 CMP Healthcare Media Group LLC March 25, 2008
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