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Guidewire
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St. Jude Medical and Volcano Corp. Have Apparently Decided to Stand Down
Aug 14, 2014St. Jude Medical and Volcano Corp. have apparently decided to stand down when it comes to lawsuits related to technologies including tunable lasers used in optical coherence tomography (OCT) imaging systems. The two companies have agreed ...
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FDA Panel Recommends Approval for Bard's Drug-Coated Balloon
Jun 16, 2014FDA's Circulatory System Devices Advisory Panel has submitted a unanimous approval recommendation for C.R. Bard's Lutonix Drug Coated Balloon (DCB) Percutaneous Transluminal Angioplasty (PTA) catheter. If FDA follows the recommendations ...
Tags: Health, Medicine, FDA, Certification
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Benvenue Medical Obtains Approval From FDA for Its Kiva VCF Treatment System
Feb 7, 2014Benvenue Medical, a medical device company, has obtained 510(k) approval from the US Food and Drug Administration (FDA) for its Kiva VCF treatment system for the reduction and treatment of spinal fractures. The FDA marketing clearance is ...
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FDA Approval for Safesept Guidewire Was Obtained by Pressure Products
Jan 26, 2014US-based Pressure Products has obtained the US Food and Drug Administration (FDA) approval for its SafeSept needle free transseptal guidewire for use with any introducer system when crossing the interatrial septum. SafeSept, which assists ...
Tags: FDA, Dr James McCready, Royal Sussex County, SafeSept
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Argon Announced That The Company Has Received Clearance From Food and Drug Administration
Jan 16, 2014Argon Medical Devices, Inc. announced today that the company has received clearance from the US Food and Drug Administration to begin marketing the Option™ELITE retrievable inferior vena cava (IVC) filter with a new over-the-wire ...
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FDA Approval for Prodigy Support Catheter Was Obtained by Radius Medical
Jan 13, 2014Radius Medical has announced the US Food and Drug Administration (FDA) approval and product introduction of its new Prodigy support catheter. The company has designed the Prodigy support catheter for providing back up support to the ...
Tags: Radius Medical, Medicine
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Approvals for Catheter and Supercross FT Microcath Has Been Obtained by Vascular Solutions
Dec 13, 2013Vascular Solutions, a medical device company, has obtained Shonin approvals from the Japanese Ministry of Health, Labour and Welfare (MHLW) for its GuideLiner guide extension catheter and the SuperCross FT microcatheter. Japan Lifeline, ...
Tags: Vascular Solutions, medical device, MHLW, extension catheter
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FDA Indication for Viabahn Endoprosthesis for Revision of AV Access Is Expanded by Gore
Dec 13, 2013W. L. Gore & Associates (Gore) has obtained the US Food and Drug Administration (FDA) approval for its GORE VIABAHN endoprosthesis for the treatment of stenosis or thrombotic occlusion at the venous anastomosis of synthetic arteriovenous ...
Tags: Gore, FDA, GORE VIABAHN, endoprosthesis, AV access
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Japanese Approval for Gore C3 Delivery System Is Received by Gore
Dec 4, 2013W. L. Gore & Associates, Inc. (Gore) has received Shonin approval from the Japanese Ministry of Health, Labor and Welfare to market the GORE EXCLUDER AAA endoprosthesis featuring C3 Delivery System as a minimally invasive treatment for ...
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The FDA Recently Announced Another Class I Recall, This Time in The Cardiovascular Space.
Nov 22, 2013The FDA recently announced another Class I recall, this time in the cardiovascular space. The faulty products from Medtronic are guidewires with surface coatings that could potentially divide and detach. The Fridley, MN-based medical ...
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Boston Scientific's Direxion Torqueable Microcatheter Obtains FDA and CE Mark Approvals
Nov 22, 2013Boston Scientific, a medical device company, has obtained the US Food and Drug Administration clearance and CE Mark approval for its Direxion torqueable microcatheter, designed to facilitate selective access and delivery of diagnostic, ...
Tags: Boston Scientific, Microcatheter
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Guidewire Software's Insurancesuite Is Selected by Tinkoff Online
Nov 15, 2013Tinkoff Online Insurance, a part of TCS Group Holding, has selected Guidewire Software's InsuranceSuite to streamline its underwriting, rating and policy administration, claims management, and billing operations. The company will install ...
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Guidewire System Is Selected by Amerisure Insurance for Claims Management
Nov 14, 2013Amerisure Mutual Insurance Company, a Property/Casualty (P/C) commercial insurer, and Guidewire Software, Inc. (GWRE), a provider of software products to P/C insurers, announced that Amerisure has selected Guidewire ClaimCenter as its new ...
Tags: Insurance, Guidewire System
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AIG Japan Is in The Process of Implementing Guidewire PolicyCenter
Nov 8, 2013Guidewire Software, Inc. (GWRE), a provider of Property/Casualty (P/C) insurance software products, announced that AIG Japan is in the process of implementing Guidewire PolicyCenter as its new underwriting and policy administration solution ...
Tags: Guidewire, Billing Systems
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Catlin Group Has Chosen Guidewire Insurancesuite as Its New Platform
Oct 17, 2013Global specialty property and casualty insurer and reinsurer, Catlin Group has chosen Guidewire InsuranceSuite as its new platform for rating, underwriting and policy administration, claims management, and billing. As part of a plan to ...
Tags: Catlin Group, Insurancesuite
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