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Bracco Diagnostics
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July 31, 2012 — Bracco Diagnostics Inc., the U.S.-based company of the Bracco Group, announced that the U.S. Food and Drug Administration (FDA) has approved the use of MultiHance (gadobenate dimeglumine) injection, 529 mg/mL, in magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
Two next-generation automated contrast injector systems were recently introduced in the United States.
Medical devices employed for injecting radio-opaque contrast media into the body to enhance the visibility of tissues for a medical imaging procedure are known as contrast injectors. Over the years, with ever-increasing technological sophistication, these contrast injectors have evolved from manual injectors having manifolds with stop-cocks to automated versions, providing added accuracy and advantages. These automated versions are known as autoinjectors. Autoinjectors are capable of controlling the amount of contrast media injected, utilization rate, and are also able to increase dosage to keep pace with fast medical imaging scanners as well as alert the physician of potential hazards, such as air embolisms or extravasations.
March 12, 2012 — A new study shows that the use of gadobenate dimeglumine, the highest relaxivity gadolinium-based contrast agent (GBCA) available for central nervous system (CNS) magnetic resonance imaging (MRI), over a high concentration MRI contrast agent may improve clinicians’ ability to visualize lesions of the brain.
January 13, 2012 – The U.S. Food and Drug Administration (FDA) is updating healthcare professionals and the public about preliminary findings from ongoing investigations following the voluntary recall of CardioGen-82 last July by the manufacturer, Bracco Diagnostics. CardioGen-82 consists of a generator that is used at clinical sites to produce rubidium (Rb)-82 chloride injection. A CardioGen-82 positron emission tomography (PET) scan is one of a variety of nuclear medicine scans that use radioactive drugs to evaluate myocardial perfusion.
January 6, 2012 – Bracco Diagnostics said it plans to close out the recall process for its CardioGen-82 cardiac perfusion radiotracer with a list of actions to bring the product back to market.
January 6, 2012 - Bracco Imaging SpA has acquired Swiss Medical Care (SMC), a Swiss company headquartered in Lausanne and engaged in research, production and marketing of automated systems for the administration of contrast agents for diagnostic imaging.
December 13, 2011 – During RSNA 2011, Bracco explained it is working with the U.S. Food and Drug Administration (FDA) to re-introduce CardioGen-82 (Rubidium Rb 82 Generator) since its recall this past summer.
The U.S. Food and Drug Administration (FDA) is alerting healthcare professionals to stop using CardioGen-82 for cardiac positron emission tomography (PET) scans. The manufacturer, Bracco Diagnostics Inc., has decided to voluntarily recall CardioGen-82 this week after two patients set off radiation detectors at a U.S. border crossings due to strontium contamination.
Despite its first commercial appearance in the late 1970s, positron emission tomograpnhy (PET) did not begin gaining widespread acceptance as a viable clinical technology until the mid-1990s. This was after it gained approval for reimbursement and radiopharmaceuticals for PET became more widely available.