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Pacemakers
St Jude Medical launches wireless MRI-conditional pacemaker in Japan
Pacemakers : 01 July, 2013
St Jude Medical receives regulatory approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) and launch of the Accent MRI Pacemaker and the Tendril MRI lead.
 
First implant of Boston Scientific Vitalio pacemaker is performed in Europe
Pacemakers : 28 June, 2013
The first patient implant of the Boston Scientific VITALIO pacemaker is performed at ZGT Hengelo in Hengelo, the Netherlands.
 
Boston Scientific pacemaker family adjusts pacing to respiration
Pacemakers : 27 June, 2013
Boston Scientific is launching a new family of pacemakers in Europe which monitor respiration, adjust pacing accordingly, and support insight into the patient's overall heart failure status.
 
Clinical study validates pacemakers for sleep apnea monitoring against polysomnography
Pacemakers : 25 June, 2013
Sorin Group reveals the results of the DREAM clinical trial.
 
Sorin Group launches family of pacemakers with sleep apnea monitoring
Pacemakers : 20 June, 2013
Sorin Group receives CE mark approval and the European commercial launch of the REPLY 200 family of pacemakers featuring Sleep Apnea Monitoring (SAM).
 
Medtronic launches Japan's first MR-conditional pacemaker system
Pacemakers : 22 October, 2012
Medtronic receives Japanese regulatory approval and plans to launch the Advisa DR MRI SureScan pacing system which is the first and only MR-Conditional pacemaker available to patients in Japan, the world's second largest market for medical devices.
 
World's smallest pacemakers feature algorithms to improve patient safety
Pacemakers : 14 September, 2012
Sorin Group receives marketing approval from China's State Food and Drug Administration (SFDA) and full commercial launch in China of the REPLY and ESPRIT families of pacemakers.
 
Family of pacemakers receives CE Mark approval for use in MRI scans
Pacemakers : 30 July, 2012
Boston Scientific receives CE Mark approval for use of its INGENIO and ADVANTIO pacemakers in patients in need of a magnetic resonance imaging (MRI) scan.
 
Biotronik launches new external pacemaker in the USA
Pacemakers : 15 May, 2012
Biotronik is launching in the USA the company's new Reocor external pacemaker.
 
Boston Scientific reports first US implant of devices to treat bradycardia
Pacemakers : 09 May, 2012
Boston Scientific receives US Food and Drug Administration (FDA) approval and is launching the company's INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).
 
Accent MRI pacemaker and Tendril MRI lead achieve first implant
Pacemakers : 20 April, 2012
St Jude Medical achieves the first implant of the company's Accent MRI Pacemaker and Tendril MRI Lead IDE Study (MRI Study).
 
Boston Scientific launches new family of pacemakers in Europe
Pacemakers : 12 April, 2012
Boston Scientific receives CE Mark approval and European market launch of its INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).
 
Biotronik opens new Asia Pacific HQ in Singapore
Pacemakers : 16 January, 2012
Biotronik, a manufacturer of high quality products for vascular intervention, implantable cardiac pacemakers and defibrillators, and the pioneer of wireless remote monitoring technology, is opening of a new regional headquarters location based in Singapore.
 
Biotronik receives FDA approval for new pacemakers
Pacemakers : 03 May, 2011
Biotronik receives FDA approval of the new Estella and Effecta pacemakers, as well as advanced new features and technologies for the Evia pacemaker family.
 
US FDA approves pacing system designed for use in an MRI environment
Pacemakers : 10 February, 2011
The US Food and Drug Administration (FDA) approves Medtronic’s Revo MRI SureScan pacing system, the first and only pacemaker in the US specifically designed for use in an Magnetic Resonance Imaging (MRI) environment and approved as MR-Conditional.
 
Biotronik expands portfolio of pacing therapies for advanced patient management.
Pacemakers : 03 December, 2010
Biotronik SE is expanding the company’s comprehensive portfolio of pacing therapies with more solutions that serve a broad range of therapy needs for advanced patient management.
 
Biotronik’s Evia pacemaker is fitted to first US patient
Pacemakers : 24 May, 2010
Biotronik reports that 14-year-old Maria Stebbins of Washington, DC became the first patient in the United States to receive Biotronik’s newly FDA-approved Evia pacemaker.
 
World’s smallest, wireless remote monitoring system gains FDA approval
Pacemakers : 14 May, 2010
The US Food and Drug Administration clears Biotronik’s Evia pacemaker for distribution in the USA, giving physicians and patients access to a Bradycardia system designed and manufactured with Biotronik’s unparalleled legacy of quality.
 
Bradycardia systems are compatible with MRI scanners
Pacemakers : 09 April, 2010
Biotronik receives European approval of its new ProMRI Pacing Systems – Evia pacemaker series and Safio S pacing leads – providing European patients the first portfolio of bradycardia systems that are compatible with Magnetic Resonance Imaging (MRI) scans under specific conditions.
 
Medtronic receives CE Mark for second-generation pacemaker
Pacemakers : 22 June, 2009
Medtronic receives CE Mark for the company’s second-generation pacemaker designed, tested, approved for use as labelled with MRI machines, the Advisa DR MRI SureScan pacing system.
 
Small subset of Medtronic Kappa and Sigma series pacemakers to be recalled
Pacemakers : 12 June, 2009
The US Food and Drug Administration (FDA) has classified Medtronic’s previously announced physician advisory about a small subset of Kappa and Sigma series pacemakers, identified at increased susceptibility for separation of bonded interconnect wires from the electronic circuit, as a Class I recall.
 
Boston’s Altrua family of pacemakers receives US FDA approval
Pacemakers : 08 May, 2008
Boston Scientific has received US FDA approval of the company’s Altrua family of pacemakers.
 
Boston Scientific launches new pacemaker family in Europe
Pacemakers : 07 May, 2008
Boston Scientific has received CE Mark approval and has launched its Altrua family of pacemakers in Europe.
 
 
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