February 9, 2011 – The U.S. Food and Drug Administration (FDA) granted 510(k) clearance for enhanced software that automatically detects significant (50 percent and more) stenotic lesions in coronary arteries from coronary computed tomography angiography (CTA) studies. The COR Analyzer system, from Rcadia Medical Imaging, is designed to help speed detection of coronary artery disease.

February 9, 2011 – The U.S. District Court for the District of Delaware reaffirmed an April 2010 federal jury decision that determined Medtronic CoreValve LLC willfully infringed Edwards Lifesciences' U.S. Andersen transcatheter heart valve patent and awarded Edwards $74 million in damages.

February 9, 2011 – The U.S. Food and Drug Administration (FDA) said certain lots of the Arstasis One femoral artery access system are part of a Class 1 recall. Components of the device may fracture and/or separate during use, which may result in patient harm, the FDA said.

February 9, 2011 – A partnership has been formed to launch a portable therapeutic cooling system in Europe. Physio-Control and BeneChill will work together to launch the RhinoChill IntraNasal Cooling System, a noninvasive system for transnasally lowering the body’s core temperature immediately following cardiac arrest, stroke or traumatic brain injury

February 9, 2011 – The U.S. Food and Drug Administration (FDA) approved the first pacemaker in the United States specifically designed for use in an magnetic resonance imaging (MRI) environment and approved as MRI-conditional. Medtronic said its Revo MRI SureScan pacing system is available immediately.


Interoperability is key to the meaningful use and sharing of patients’ electronic images and information.

February 8, 2011 – The U.S. Food and Drug Administration (FDA) said Merit Medical Systems initiated a Class I recall for one lot of its Prelude Short Sheath Introducer, because the tips may detach during use.

The company said a detached tip may cause arterial injury, hemorrhaging or other serious events, or may enter into the bloodstream, causing blood clots.

February 8, 2011 – Researchers at the University of Southern California have developed an algorithm to produce animated magnetic resonance imaging (MRI) scans of body parts or organs in motion. Volume scans of human bodies have a variety of uses in medical diagnosis and research; however, these scans usually do not show the body in movement.

February 7, 2011 – A new positioning system has been launched that is used in performing off- pump coronary artery bypass (OPCAB) procedures on coronary artery bypass graft (CABG) patients.

February 7, 2011 – There is a tremendous unmet need for new medical technologies to treat potentially dangerous chronic venous insufficiency (CVI) and blood clots, according to a Scientia Advisors review of the vascular device market.

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