September 5, 2020
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first_img News | Interventional Radiology | July 31, 2019 International Multidisciplinary Group Publishes Recommendations for Personalized HCC Treatment With Y90 TheraSphere New consensus recommendations for personalized treatment for hepatocellular carcinoma (HCC) with BTG’s TheraSphere have… read more News | Radiopharmaceuticals and Tracers | August 02, 2019 ASRT Supports Radiopharmaceutical Reimbursement Bill The American Society of Radiologic Technologists (ASRT) announced its support for House Resolution (HR) 3772, a measure… read more Related Content Feature | August 27, 2012 Manhattan Isotope Starts Formal Process to Produce Sr-82 Technology | Information Technology | June 20, 2019 DOSIsoft Receives FDA 510(k) Clearance for Planet Onco Dose Software DOSIsoft announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market Planet… read more News | Radiopharmaceuticals and Tracers | July 26, 2019 NorthStar Medical Radioisotopes Awarded $30 Million by U.S. Department of Energy NorthStar Medical Radioisotopes LLC has been awarded $15 million in a cooperative agreement with the U.S. Department of… read more News | Computed Tomography (CT) | June 17, 2019 International Working Group Releases New Multiple Myeloma Imaging Guidelines An International Myeloma Working Group (IMWG) has developed the first set of new recommendations in 10 years for… read more Figure 1. A high-fidelity 3-D tractography of the left ventricle heart muscle fibers of a mouse from Amsterdam Ph.D. researcher Gustav Strijkers. News | Radiopharmaceuticals and Tracers | July 01, 2019 Bracco Imaging Acquires Blue Earth Diagnostics Bracco Imaging S.p.A. has signed a definitive agreement to acquire Blue Earth Diagnostics, a molecular imaging company… read more News | PET-CT | August 15, 2019 United Imaging Announces First U.S. Clinical Installation of uExplorer Total-body PET/CT United Imaging announced that its uExplorer total-body positron emission tomography/computed tomography (PET/CT) system… read more August 27, 2012 — Positron Corp., a molecular imaging healthcare company, announced the submission of a drug master file (DMF) with the U.S. Food and Drug Administration (FDA) for the production of active pharmaceutical ingredient (API)-grade strontium-82 (Sr-82) through its wholly owned subsidiary, Manhattan Isotope Technology LLC (MIT). This will offer a second source for the nuclear myocardial perfusion cardiac imaging agent.A DMF is a document submitted to the FDA that contains complete information on an API or finished drug dosage form. The DMF contains factual and complete information on a drug product’s chemistry, manufacturer, stability, purity, impurity profile, packaging and the cGMP status of any human drug product. The main objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product.Manhattan Isotope’s DMF submission initiates the protocol, procedures and compliance required to produce Sr-82 for radiopharmaceutical applications, specifically for commercial use in Sr-82/Rubidium (Rb)-82 generators. Sr-82/Rb-82 generator manufacturers may now qualify MIT as a supply source and vendor for API grade Sr-82. Manhattan Isotope’s DMF positions the company as the only commercial entity in the United States in the Sr-82 processing and production arena. Currently, the U.S. Department of Energy (DOE) is the only domestic supplier for many of the more than 300 different isotopes, which are critical in medical, commercial, research and national security applications. Recent shortages have emphasized the importance of managing the demand for critical isotopes.“Our submission of the DMF is a very significant milestone, as it signifies Positron’s evolution towards a vertically integrated nuclear medicine healthcare company,” said Jason Kitten, president of MIT. “Positron, through MIT, is the first private entity to demonstrate the expertise and ability to enter the market as a processor and supplier of API-grade strontium-82. Proficiencies in this segment are key to our end-to-end solution strategy. Positron’s ability to supply strontium and support production needs will not only stabilize the source supply of strontium-82, but will also lend growth to and strengthen the cardiac positron emission tomography (PET) market as a whole.”For more information: www.positron.com FacebookTwitterLinkedInPrint分享 News | Magnetic Resonance Imaging (MRI) | June 07, 2019 Amsterdam University Medical Center Wins MR Solutions’ Image of the Year Award The Amsterdam University Medical Center has won MR Solutions’ Image of the Year 2019 award for the best molecular… read more News | Radiopharmaceuticals and Tracers | July 16, 2019 NorthStar Medical Radioisotopes Completes Construction on Beloit, Wis. Molybdenum-99 Processing Facility NorthStar Medical Radioisotopes LLC  announced completion of construction on its 20,000-square-foot molybdenum-99 (Mo-… read more News | PET-CT | June 19, 2019 United Imaging Announces First U.S. Clinical Install of uMI 550 Digital PET/CT United Imaging announced the first U.S. clinical installation of the uMI 550 Digital positron emission tomography/… read more X-ray images such as the one on the left fail to indicate many cases of advanced bone destruction caused by multiple myeloma, says the author of new guidelines on imaging for patients with myeloma and related disorders. Image courtesy of Roswell Park Comprehensive Cancer Center.last_img

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