December 10, 2008 - ICON today said its medical imaging division launched a new cardiac echocardiography analysis software solution, MIRA-ECHO, which enables echo images to be viewed, measured and interpreted in clinical trials and is the latest addition to ICON Medical Imaging's proprietary MIRA (Medical Imaging Review and Analysis) platform.

December 10, 2008 – ev3 today said it received FDA 510(k) clearance from the FDA to market its EverCross 0.035-inch and NanoCross 0.014-inch peripheral angioplasty balloon catheters.

December 9, 2008 - Slowing heart rate with exercise and stress reduction may help extend life, reports the December 2008 issue of the Harvard Heart Letter.

December 9, 2008 – St. John’s Health Center and Cheetah Medical Inc. announced the health center was designated a Center of Excellence for the new Reliant Hemodynamic Monitoring System, which in addition to other vital parameters, monitors how much blood the heart pumps with each heartbeat.

Clinical studies demonstrated that having this information available, and using it with other inputs to guide treatment, can help to prevent or decrease the incidence and risk of complications from a number of leading health conditions through improved patient management.

December 9, 2008 - Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes, after receiving five reports of difficulty retracting the introducer from the cannula.

December 9, 2008 - PLC Systems Inc. said recently it has received full approval from the FDA for its U.S. pivotal trial to study the effectiveness of the its RenalGuard System and associated therapy in the prevention of Contrast-Induced Nephropathy (CIN).

The FDA also approved PLC's request to expand their investigation from the 246 patients conditionally approved earlier this year to 406 patients and eliminate the requirement for an interim study analysis to be performed. As a result of this and other changes, the study is no longer considered an adaptive study.

December 8, 2008 – Investigators say CORE 64 shows that CT angiography can accurately identify the presence and severity of obstructive coronary artery disease in symptomatic patients, but that it is not yet ready to replace invasive coronary angiography.

December 8, 2008 - As the next phase in validating advanced computed tomography technology in a clinical setting, Toshiba Medical Systems Corporation (TMSC) will support CORE 320, the largest worldwide multi-center trial comparing the effectiveness of 320-detector row dynamic volume CT to SPECT technology.

December 8, 2008 - Viatronix Inc., a developer of 3D imaging software, reported it received FDA 510(k) market clearance for its V3D-Cardiac module.

December 8, 2008 - ZOLL Medical Corp. said last week more than 12,000 patients at high risk of sudden cardiac arrest (SCA) have been prescribed the ZOLL LifeVest Wearable Defibrillator by their physician since it was approved by the FDA in 2002.

The company said this represents more than 2,000 years of cumulative patient time wearing a LifeVest, and, in any given month, more than 1,000 patients are being protected from sudden death wearing the LifeVest, Zoll said.

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