St. 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 ...
FDA'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
Benvenue 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 ...
US-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
Argon 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 ...
Radius 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
Vascular 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
W. 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
W. 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 ...
The 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 ...
Boston 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
Tinkoff 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 ...
Amerisure 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
Guidewire 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
Global 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