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April 7, 2010 – A medical manufacturer pleaded guilty Monday to criminal violations for improper reporting of short-circuit failures of three models of its implantable cardioverter defibrillators (ICDs), the Justice Department announced. The company also agreed to pay more than $296 million in damages.

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April 7, 2010 – The U.S. Food and Drug Administration (FDA) recently sent a warning letter to Edwards Lifesciences Corp. for late reporting of adverse events with its medical devices.

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April 7, 2010 – A study concludes ventilator efficiency (VE/VCO2 slope) is more accurate than the current listing criteria for heart transplantation in identifying patients likely to derive a survival benefit from such intervention. The results were recently published in Circulation Heart Failure, a journal of the American Heart Association.

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April 6, 2010 – An upgrade to a popular advanced visualization software suite now allows support for the iPod Touch, iPhone and iPad. The release of version 4.4.5 of the Aquarius iNtuition server-based software provides access to images and advanced visualization through an intuitive, mobile and multitouch user interface.

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April 5, 2010 – Patient enrollment was recently completed in the Small Vessel and Long Lesion trials of the PLATINUM clinical program. It is designed to compare the platinum chromium Promus Element Everolimus-Eluting Stent to matched historical control groups of patients treated with the Taxus Express2 Paclitaxel-Eluting Stent.

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April 5, 2010 – The U.S. Food and Drug Administration (FDA) today said it approved the first absorbable fibrin sealant patch for use in cardiovascular surgery to prevent mild and moderate bleeding from small blood vessels, when standard surgical techniques are ineffective or impractical.

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April 5, 2010 - If used early, advanced imaging techniques such as computed tomography (CT) scans and magnetic resonance imaging (MRI) might shorten the length of a person's hospital stay and decrease costs associated with hospitalization, according to a study in the April issue of the Journal of the American College of Radiology.

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April 2, 2010 – Integrating a sleep disorder diagnostic tool into hospital cardiac care, the MARS Virtual Sleep Lab (VSL) was recently introduced at ACC 2010. It is the first device to provide a streamlined view of quantitative cardiac and sleep apnea analysis from any GE-monitored inpatient bed, helping enhance speed of diagnosis.

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April 2, 2010 – The FDA, Society of Nuclear Medicine (SNM) and the Radiological Society of North America (RSNA) are hosting a joint two–topic workshop, April 13–14, at the Natcher Conference Center of the National Institutes of Health, Bethesda, Md.

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April 2, 2010 – A federal jury yesterday found Medtronic’s CoreValve transcatheter aortic valve willfully infringes on patents owned by Edwards Lifesciences. Edwards said it intends to seek a permanent injunction. The jury also awarded Edwards $74 million in damages, and the willfulness finding allows Edwards to seek increased damages of up to three times that amount, the company said.

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April 1, 2010 – A new partnership will deliver multimodality cardiovascular image analysis as a part of a forthcoming Web-based service to simplify workflow and save time in cardiology practices.

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March 31, 2010 - The number of magnetic resonance imaging (MRI) scans performed increases each year, as does the number of people with implanted cardiac devices.

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March 31, 2010 — A Web-based suite of clinical and reporting tools for cardiology, cardiovascular and vascular imaging has been deployed at Warren Hospital in Phillipsburg, N.J.

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March 31, 2010 — Boston Scientific Corp. recently announced that it has stopped shipment and is retrieving field inventory of all its implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), after a planned process review revealed that two manufacturing process changes were not submitted for FDA approval.

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March 31. 2010 – The FDA granted Clinical Laboratory Improvement Amendments (CLIA)-waived status to expand the use of a point-of-care anti-coagulation monitor to a broader range of clinical settings. The CoaguChek XS Plus system offers connectivity and data management tools to help healthcare professionals manage PT/INR testing.

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