Nordion to manufacture NAV5001 agent for clinical trials | FDA clears upgrade for PET systems | Docs see care quality but not cost benefits to HIT, survey shows
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May 17, 2013
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Top Story
PET/CT bests biopsy in diagnosing lymphoma bone marrow involvement
A study published in The Journal of Nuclear Medicine said 18F-FDG-PET/CT is better than the standard bone marrow biopsy in detecting bone marrow involvement in diffuse large B-cell lymphoma. PET/CT identified bone marrow involvement in 32 patients, while biopsy detected bone malignancy in eight patients. PET/CT also showed better performance in terms of sensitivity, predictive value and negative predictive value. MolecularImaging.net (5/15)
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Clinical News & Research
Nordion to manufacture NAV5001 agent for clinical trials
Nordion has inked a deal with Navidea Biopharmaceuticals, agreeing to manufacture the imaging agent NAV5001 for Navidea's Phase IIb and Phase III trials expected to start this year. The agent is used in diagnosing Parkinsonian syndromes and dementia with Lewy bodies. The deal is initially effective for three years. Pharmaceutical Business Review Online (5/16)
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Industry Report
FDA clears upgrade for PET systems
Medical Imaging Electronics and Nuclear Imaging Services said they have been granted 510(k) clearance by the FDA for their ECAT Scintron upgrade, which enhances Siemens Healthcare's ECAT 47, ECAT HR+ and ECAT Accel legacy PET systems. The company said the upgrades will make new acquisition protocols available to users and allow them to process images faster, among other advantages. AuntMinnie.com (free registration) (5/16)
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News from the Field
Docs see care quality but not cost benefits to HIT, survey shows
Data from a Deloitte poll showed 73% of responding physicians believe health IT will offer long-term care quality benefits, while 74% said they strongly agreed that billing accuracy and speed was the most beneficial effect of EHR use. However, 71% of respondents said they think increased health IT adoption will fail to deliver on predictions of lower costs. BeckersOrthopedicAndSpine.com (5/15)
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Health Policy
FDA clarifies existing guidance on medical-device appeals
Draft guidance issued by the FDA aims to explain its existing guidelines for medtech companies seeking to appeal the regulatory actions and decisions of the agency's device center. The proposal is up for comment for 90 days and will be added as an appendix to the FDA's current appeals guidance when finalized. MassDevice.com (Boston) (5/16)
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Drug-tracking measure obtains House panel OK
A House panel approved along party lines a measure that would strengthen the tracking of prescription treatments. The FDA will be required to propose new regulations to protect consumers from counterfeit prescriptions by 2027, but the measure does not require that those rules be put into effect. The Hill/RegWatch blog (5/15)
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Advancing Health Care
Sanofi partners with PatientsLikeMe for clinical trial recruitment
Drugmaker Sanofi and the nonprofit Center for Information and Study on Clinical Research Participation will use PatientsLikeMe's clinical trial awareness tool to recruit participants in trials for asthma, cardiovascular disease, diabetes and oncology drugs. Educational materials from the CISCRP will help potential participants understand the clinical research process. MedCityNews.com (5/14)
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From SNMMI
Did you know?
SNMMI's Annual Meeting — June 8-12 — has categorical seminars to enhance your learning experience, including "Neurodegenerative Imaging," "Hybrid Imaging in Pediatric Nuclear Medicine," "Emerging Technology: Discover the Future," "Challenges of Regulatory & Reimbursement Approval for Molecular Imaging Agents" and more! Search the educational and scientific program to find sessions of interest to you. Then, make your plans to join 4,000 of your colleagues in Vancouver, British Columbia!
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Diagnostic CT and PET/CT cases available
Meet PET/CT and Diagnostic CT training and credentialing recommendations. These cases have been designed so nuclear medicine physicians with no recent CT training can supervise and interpret CT images in conjunction with PET or SPECT. They also allow radiologists with no recent PET training to supervise and interpret PET images in conjunction with CT. Get started today.
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SmartQuote
Divide each difficulty into as many parts as is feasible and necessary to resolve it."
-- René Descartes,
French mathematician and philosopher
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The news summaries appearing in SNMMI SmartBrief are based on original information from multiple internet sources and are produced by SmartBrief, Inc., an independent e-mail newsletter publisher. The items above are not selected or reviewed by SNMMI prior to publication. Questions and comments may be directed to SmartBrief at snmmi@smartbrief.com.
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