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MRI News Service:
'Food and Drug Administration'  p6
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Result: Searchterm 'Food and Drug Administration' found in 75 news
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U.S. FDA Approves Bayer's Gadobutrol Injection for MRI of the Central Nervous System
'''''Bayer HealthCare Pharmaceuticals announced today that the U.S. Food and Drug Administration has approved Bayer's gadobutrol injection Gadavistâ„¢ (gadobutrol), a 1.0 molar macrocyclic gadolinium-based contrast agent (GBCA) for intravenous use in ...'
Tuesday, 15 March 2011   by viva.vita.bayerhealthcare.de
Medtronic, Inc. (MDT) Receives FDA Approval for First and Only Pacemaker System in the U.S. Designed for Use in the MRI Environment
'''''Medtronic, Inc. (NYSE:MDT - News) today announced that the U.S. Food and Drug Administration (FDA) approved its Revo MRI™ SureScan® pacing system, the first and only pacemaker in the U.S. specifically designed for use in an Magnetic Resonance Imaging ...'
Tuesday, 8 February 2011   by www.biospace.com
FDA Advisory Committee Recommends Approval of Bayer Corporation (BAY)'s Gadobutrol Injection for MRI of the Central Nervous System
'''''Bayer HealthCare Pharmaceuticals Inc. announced today that the Peripheral and Central Nervous System Drugs Advisory Committee to the U.S. Food and Drug Administration (FDA) voted unanimously that clinical trial and postmarketing data for gadobutrol ...'
Friday, 21 January 2011   by www.biospace.com
Covidien Supports FDA's Patient Safety Efforts for Gadolinium-Based Contrast Agents
'''''Covidien (NYSE:COV), a leading global provider of healthcare products, today announced it supports the U.S. Food and Drug Administration's (FDA) labeling changes for gadolinium-based contrast agents for patients with acute kidney injury or chronic, ...'
Friday, 10 September 2010   by investor.covidien.com
Lantheus Medical Imaging, Inc. Commends Safety Labeling Changes Announced by U.S. Food and Drug Administration for Gadolinium-Based Contrast Agents
''''' Lantheus Medical Imaging, Inc., a worldwide leader in diagnostic medical imaging, supports the U.S. Food and Drug Administration's (FDA) announcement requiring safety-related label changes for all gadolinium-based contrast agents to highlight the rare ...'
Friday, 10 September 2010   by www.radiopharm.com
FDA: New warnings required on use of gadolinium-based contrast agents
'''''The U.S. Food and Drug Administration is requiring that gadolinium-based contrast agents (GBCAs) carry new warnings on their labels about the risk of a rare and potentially fatal condition known as nephrogenic systemic fibrosis (NSF), if the drug is ...'
Thursday, 9 September 2010   by www.fda.gov
FDA Accepts New Drug Application For Gadovist® 1.0 Injection In Magnetic Resonance Imaging
'''''Bayer Schering Pharma AG, Berlin, Germany, announced today that the Food and Drug Administration (FDA) has accepted for filing a New Drug Application to the U.S. for gadobutrol injection, a gadolinium-based contrast agent for magnetic resonance ...'
Friday, 6 August 2010   by www.medicalnewstoday.com
FDA Accepts New Drug Application for Gadovist® 1.0 Injection in Magnetic Resonance Imaging
'''''Bayer Schering Pharma AG, Berlin, Germany, announced today that the Food and Drug Administration (FDA) has accepted for filing a New Drug Application to the U.S. for gadobutrol injection, a gadolinium-based contrast agent for magnetic resonance ...'
Wednesday, 4 August 2010   by viva.vita.bayerhealthcare.de
Key Alzheimer's Drug Development Stakeholders Join Forces To Establish Clinical Trial Safeguards And Accelerate Discovery
'''''New recommendations to protect participant safety in clinical trials of certain Alzheimer's disease drugs have been accepted by the U.S. Food and Drug Administration (FDA) and are already being incorporated into research studies. These safety ...'
Monday, 12 July 2010   by www.prnewswire.com
Medtronic's Study in Trouble
'''''Medtronic Inc. (MDT - Analyst Report) has received several complaints from the U.S. Food and Drug Administration (FDA) regarding the company's study of a new pacemaker that can be used in a Magnetic Resonance Imaging (MRI) machine. The FDA has raised ...'
Wednesday, 17 March 2010   by www.zacks.com
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