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The Agency Has Given De Novo Approval to The Deka Arm System
May 13, 2014An FDA news release has announced that the agency has given de novo approval to the Deka Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram ...
Tags: Bionic Arm, medical device
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FDA Approved Its Single- and Dual-Chamber Entovis Pacemakers for Use in MRI Environments
May 9, 2014FDA has approved its single- and dual-chamber Entovis pacemakers for use in MRI environments, according to Biotronik Inc. The Lake Oswego, OR–based US subsidiary of Biotronik SE & Co. KG (Berlin) said in a press release that its ...
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FDA Approval Has Been Obtained by Biotronik for Phase B of Promri Clinical Trial
Nov 25, 2013Biotronik, a manufacturer of cardiovascular medical devices, has obtained the US Food and Drug Administration (FDA) approval for Phase B of the company’s ongoing ProMRI clinical trial. Biotronik has recently completed Phase A of the ...
Tags: Promri Clinical Trial, Biotronik
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Medtronic Has Obtained FDA Approval for Its Lia Software for Use with Non-Medtronic
Nov 12, 2013Medtronic has obtained the US Food and Drug Administration (FDA) approval for its Lead Integrity Alert (LIA) software for use with non-Medtronic leads to detect defibrillator lead issues. LIA software has been approved by the FDA to ...
Tags: Medtronic, PDA, LIA, non-medtronic
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Biomedical Obtained CE Mark Approval for Its Pk Papyrus Covered Coronary Stent System
Nov 7, 2013Germany-based biomedical technology company Biotronik has obtained CE Mark approval for its PK Papyrus covered coronary stent system for use in the treatment of acute coronary artery perforation. According to Biotronik, the company's PK ...
Tags: Coronary Stent System, Medicine
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Bioabsorbable Magnesium Scaffold Is Implanted by Biotronik in First Patient in Germany
Oct 16, 2013Biotronik, a manufacturer of cardio and endovascular medical devices, has announced that its DREAMS scaffold (DRug Eluting Absorbable Metal Scaffold) has been successfully implanted in the first coronary artery disease patient in Germany as ...
Tags: Biotronik, medical devices
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New Ilesto DX System Is Introduced by Biotronik
Oct 8, 2013Biotronik, a manufacturer of cardiovascular medical technology, has introduced its Ilesto DX system, which offers the established benefits of the DX System in a thinner and smaller device. This launch follows the approval from the US Food ...
Tags: Biotronik, Ilesto DX System
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Passeo-35 Balloon Line Extension Is Launched by Biotronik
Oct 8, 2013German medical device company Biotronik has launched its Passeo-35 0.035” OTW PTA balloon line extension and the Passeo-35 HP 0.035” high pressure PTA (percutaneous transluminal angioplasty) balloon. Available in lengths of up ...
Tags: Biotronik, Balloon Line Extension
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Positive Results From in-Time Study Is Unveiled by Biotronik
Sep 3, 2013Biotronik has unveiled the results from the IN-TIME study, a first randomized, controlled trial designed to assess the influence of Biotronik Home Monitoring on all-cause mortality in heart failure patients at the ESC (European Society of ...
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CE Mark Is Granted by EU to Biotronik Ilesto 7 CD/CRT-D Series
Feb 19, 2013Germany-based Biotronik has obtained CE mark approval for its Ilesto 7 implantable cardioverter-defibrillator/cardiac resynchronization therapy defibrillator (ICD/CRT-D) series. The Ilesto 7 series, which the company claims to include the ...
Tags: ProMRI technology, DF4 connector, MR scans
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Biotronik Is Set to Showcase Its MRI Approved Implantable Heart Failure Devices
Dec 18, 2012Biotronik is set to showcase its magnetic resonance imaging (MRI) approved implantable heart failure devices at the European Society of Cardiology congress, being held between 25-29 August 2012. The MRI-approved devices include Lumax 740 ...
Tags: Biotronik, MRI, heart failure devices, MRI-approved devices, CRT-D, CRT-P
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Biotronik Has Launched a Subcutaneous Implantable Leadless Cardiac Monitoring System
Dec 18, 2012Biotronik has launched a subcutaneous implantable leadless cardiac monitoring system for European patients with atrial fibrillation (AF) or unexplained syncope, bradycardia, sudden rate drop, asystole and tachycardia. By using the ...
Tags: Biotronik, launch, cardiac monitoring system, AF, ClearSense technology
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Endosense Has Obtained CE Mark Approval for Its Tacticath Quartz
Dec 17, 2012Endosense has obtained CE mark approval for its TactiCath Quartz force-sensing ablation catheter for the treatment of atrial fibrillation and supraventricular tachycardia. The TactiCath Quartz includes a new force sensor that provides ...
Tags: Endosense, TactiCath Quartz
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Biotronik Reports Efficacy Results From GOLDEN TIME Study of AlCath Gold Ablation Catheter
Dec 17, 2012Biotronik has reported efficacy results from GOLDEN TIME study of its AlCath Gold ablation catheter. The study, conducted at the Budapest University of Technology and Economics in partnership with Erasmus Medical Center, was designed to ...
Tags: Biotronik, gold-tip catheter, AlCath Gold ablation catheter
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Biotronik Reports First US Patient Has Been Implanted with Its Lumax 740 Dual-Chamber ICD
Dec 17, 2012Biotronik has reported that the first US patient has been implanted with its Lumax 740 dual-chamber implantable cardioverter defibrillator (ICD). Lumax 740 dual-chamber ICD features SMART detection, which discriminate between atrial and ...
Tags: Lumax 740 dual-chamber implantable cardioverter defibrillator
