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April 12, 2012 – Abbott announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) for the next-generation Xience Prime Everolimus-Eluting Coronary Stent System for the treatment of coronary artery disease. XIENCE PRIME, which uses the same drug and biocompatible polymer as the XIENCE V Everolimus Eluting Coronary Stent System, features an enhanced stent design and a delivery system designed for greater flexibility, ideal radial strength, excellent longitudinal strength and more accurate stent placement. With this approval in Japan, XIENCE PRIME is available in all of the major markets worldwide, including the United States, Europe, China, India and other countries in the Asia-Pacific and Latin America regions.

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April 17, 2012 - On April 9, 2012, the FDA's Center for Devices and Radiological Health (CDRH) launched its second version of the Innovation Pathway, called "Innovation Pathway 2.0." This program offers new and modified tools and methods to deepen collaboration between the FDA and innovators early in the process, prior to pre-market submission, with the goal of making the regulatory process more efficient and timely.

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April 17, 2012 – SynCardia Systems Inc., manufacturer of the world’s first and only FDA-, Health Canada- and CE-approved Total Artificial Heart, announced that the U.S. Food and Drug Administration (FDA) has approved a Humanitarian Use Device (HUD) designation for the SynCardia temporary Total Artificial Heart to be used for destination therapy in addition to its current PMA approval as a bridge to transplant.

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April 16, 2012 — Medic Vision Imaging Solutions Ltd. announced that within six months of clinical use in the United States, its SafeCT image enhancement system has delivered diagnostic image quality to more than 20,000 CT (computed tomography) studies acquired with low-dose protocols.

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April 16, 2012 - 480 Biomedical announced that it has initiated the first human trial of its groundbreaking Stanza self-expanding bioresorbable scaffold for the treatment of peripheral artery disease (PAD) in the superficial femoral artery (SFA). The Stanza scaffold restores blood flow to the leg by propping open the diseased artery during the critical healing period, similar to conventional metal stents, but then is resorbed by the body. Observations from the first patients in the STANCE trial were reported on April 14 at the 34th Charing Cross International Symposium in London.

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April 16, 2012 - Prime Healthcare Services (PHS), a hospital management company based in Ontario, Calif., currently owns and operates 16 acute-care hospitals. In February 2012, PHS signed a master agreement with Infinitt North America to replace PACS and cardiology PACS at several of its California hospitals.

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April 15, 2012 - St. Jude Medical Inc., a global medical device company, announced CE Mark Approval of the Ellipse implantable cardioverter defibrillator (ICD). Designed with feedback from more than 200 physicians from around the world, the Ellipse ICD provides the benefits of advanced features and power in the industry’s smallest high-energy ICD.

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April 16, 2012 — Philips Healthcare announced it is collaborating with Brainlab AG to create a comprehensive intra-operative magnetic resonance imaging (MRI) solution with the goal of streamlining neurosurgery procedures. Ingenia MR-OR is based on Philips’ digital broadband Ingenia MRI system, 1.5T and 3.0T, and is designed to be combined with Brainlab’s integrated operating room (OR) solutions.

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April 13, 2012 — Researchers at The Ohio State University (OSU) Wexner Medical Center have successfully used nanotechnology to target a protein that plays a key role in atherosclerosis and inflammation, and say the study is an important advance toward using immunotherapy to simultaneously diagnose and treat cardiovascular disease.

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April 12, 2012 — Several innovative cardiovascular and radiology technologies were featured in Medical Device and Diagnostic Industry (MD+DI) magazine’s April issue, which also announced the finalists in the 2012 Medical Design Excellence Awards (MDEA) competition.

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April 12, 2012 - Abiomed Inc., a provider of heart support technologies, announced it has received CE marking approval in the European Union to market the Impella cVAD device, a new percutaneous Impella heart pump that provides peak flow of approximately 4 liters of blood per minute. The Impella cVAD is designed to provide temporary circulatory support via a minimally invasive, catheter-based pump that is insertedpercutaneously, without the need for surgical intervention.

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The gloves are off and the fight has begun between St. Jude Medical and Medtronic over clinical data regarding their implantable cardioverter defibrillator (ICD) leads. St. Jude, the medical device manufacturer of the recently recalled Riata and Riata ST ICD leads, is defending itself this week against a report in the Heart Rhythm Journal, from the Heart Rhythm Society, by Robert Hauser, M.D., FACC, of the Minneapolis Heart Institute (Hauser et al., “Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads”).

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Technology

April 12, 2012 – Terumo Interventional Systems recently announced the nationwide availability of the Azur D35 Framing Coil, the first truly detachable coil that precisely frames the targeted area for peripheral embolization.

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Philips Healthcare recently installed an Allura Xper FD 20/20 biplane angiography X-ray system at Primary Children's Medical Center in Salt Lake City, with a National Basketball Association (NBA) theme to put children at ease prior to and during interventional radiology procedures.

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April 12, 2012 - Boston Scientific Corporation announced the United States market launch of its Z Flex-270 Steerable Sheath. The device is intended for use in a wide range of electrophysiology (EP) procedures to facilitate the introduction and placement of diagnostic and therapeutic catheters within the heart. The company plans to launch the product immediately in the United States.

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