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Result: Searchterm 'Food and Drug Administration' found in 73 news
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FDA Approves First Macrocyclic and Ionic Gadolinium-Contrast Agent for MRI
'''''Guerbet announced that the U.S. Food and Drug Administration (FDA) has approved Dotarem (gadoterate meglumine), a gadolinium-based contrast agent (GBCA) indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine ...'
Friday, 22 March 2013   by www.itnonline.com
Resonance Health receives FDA marketing authorization for FerriScan R2-MRI device
'''''The U.S. Food and Drug Administration recently announced the authorization of FerriScan® R2-MRI to be marketed as an imaging companion diagnostic device for the safe and effective use of Exjade in patients with non-transfusion-dependent thalassemia. ...'
Thursday, 31 January 2013   by www.news-medical.net
BIOTRONIK Announces Initiation of ProMRI® Clinical Trial
'''''BIOTRONIK, a leading manufacturer of high-quality implantable cardiac devices and a pioneer of wireless remote monitoring technologies, announced today that the U.S. Food and Drug Administration (FDA) has approved, with conditions, the ProMRI® clinical ...'
Wednesday, 16 January 2013   by www.biospace.com
Siemens Healthcare (SI) MAGNETOM Spectra 3T MRI System Receives FDA Clearance
'''''Siemens Healthcare (NYSE: SI) has announced that the MAGNETOM Spectra 3 Tesla MRI system has received clearance from the U.S. Food and Drug Administration (FDA). The latest addition to Siemens' internationally renowned portfolio of MRI solutions, the ...'
Tuesday, 24 July 2012   by www.biospace.com
MRI coil optimized for imaging of infants gets FDA clearance
'''''A magnetic resonance imaging coil specialized for imaging of the infant brain, spine, heart and torso has received 510(k) clearance from the U.S. Food and Drug Administration. Cleveland-based Sree Medical Systems' obtained 510(k) clearance of its ...'
Tuesday, 17 April 2012   by www.medcitynews.com
AMAG Pharmaceuticals Announces Update to Feraheme(R) Label
'''''AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced that the company has updated the product label for Feraheme(R) (ferumoxytol) Injection for Intravenous (IV) use. This update is based on the U.S. Food and Drug Administration's approval of the ...'
Tuesday, 21 June 2011   by ir.amagpharma.com
FDA Clears New System to Perform Simultaneous PET, MRI Scans
'''''The U.S. Food and Drug Administration today cleared the Siemens Biograph mMR system, the first device to simultaneously perform a positron emission tomography scan, commonly known as PET scan, and a magnetic resonance imaging (MRI) scan. PET scans ...'
Friday, 10 June 2011   by www.prnewswire.com
Repligen Concludes Pre-NDA Meeting with FDA for RG1068
'''''Repligen Corporation (NASDAQ: RGEN) today announced that the Company has concluded a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) related to its lead product candidate, RG1068 for improvement of magnetic ...'
Wednesday, 1 June 2011   by www.businesswire.com
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 Gadavist™ (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
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