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Result: Searchterm 'Food and Drug Administration' found in 73 news
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FDA Dials in on MRI Safety of Passive Implantable Medical Devices
'''''For the second time in a year, the US Food and Drug Administration (FDA) has released new guidance intended to ensure the safety of implanted medical devices from magnetic resonance imaging (MRI) devices.BackgroundIn medicine, the context of a product's ...'
Monday, 29 June 2015   by raps.org
FDA Dials in on MRI Safety of Passive Implantable Medical Devices
'''''For the second time in a year, the US Food and Drug Administration (FDA) has released new guidance intended to ensure the safety of implanted medical devices from magnetic resonance imaging (MRI) devices.BackgroundIn medicine, the context of a product's ...'
Wednesday, 24 June 2015   by www.raps.org
FDA Approves MED-EL's SYNCHRONY Cochlear Implant
'''''MED-EL USA announced today that the U.S. Food and Drug Administration has approved the new SYNCHRONY cochlear implant. For the first time, a cochlear implant has been approved for use with 3.0 Tesla (T) MRI without the surgical removal of the internal ...'
Friday, 23 January 2015   by www.businesswire.com
FDA grants PMA-Supplement approval for Flowonix Medical's Prometra II system
'''''The US Food and Drug Administration (FDA) has granted PMA-Supplement approval for Flowonix Medical's intrathecal infusion device, the Prometra II system. Flowonix Medical intends to introduce the drug infusion device in the next few months. The ...'
Tuesday, 20 January 2015   by www.medicaldevice-network.com
FDA approves Bayer's Gadavist® (gadobutrol) injection as the first magnetic resonance contrast agent for pediatric patients less than 2 years of age
'''''Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than 2 years of age, including term neonates, to ...'
Monday, 5 January 2015   by www.prnewswire.com
Will an MRI Damage my Implant? New FDA Policy Aims to Improve Safety
'''''Can a medical device be used safely around magnetic resonance imaging equipment? It's not always easy for healthcare providers or patients to know. Now a new final guidance document issued by the US Food and Drug Administration (FDA) recommends that ...'
Friday, 12 December 2014   by www.raps.org
FDA approves Bayer's Gadavist (gadobutrol) Injection as the first magnetic resonance contrast agent for evaluation of breast cancer in the United States
'''''Bayer HealthCare announced today that the U.S. Food and Drug Administration (FDA) has approved a new indication for Gadavist® (gadobutrol) injection for intravenous use with MRI of the breast to assess the presence and extent of malignant breast ...'
Thursday, 12 June 2014   by www.prnewswire.com
FDA Clears Camino Flex Ventricular Catheter For Use With MRI Scans
'''''Integra LifeSciences Holdings Corp. (IART: Quote) said Friday that the Camino Flex Ventricular Catheter has received clearance from the United States Food and Drug Administration for use with magnetic resonance imaging. The Camino Flex Ventricular ...'
Friday, 4 April 2014   by www.rttnews.com
Medtronic obtains FDA clearance for full-body MRI with SureScan pacing systems
'''''US-based Medtronic has obtained expanded approval from the US Food and Drug Administration (FDA) for its SureScan pacing systems, which have been branded safe for magnetic resonance imaging (MRI) scans positioned on any region of the body. These are ...'
Friday, 24 January 2014   by www.medicaldevice-network.com
Rhythmlink First to Receive FDA Clearance for Disposable MR Conditional Cup Electrodes
'''''The U.S. Food and Drug Administration has cleared for marketing Rhythmlink's Disposable MR Conditional Cup Electrodes. The first of its kind to be formally authorized for use, Rhythmlink's Disposable MR Conditional Cup Electrodes have been in development ...'
Tuesday, 25 June 2013   by eon.businesswire.com
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