June 10, 2011 - A U.S. Food and Drug Administration (FDA) advisory panel is scheduled to review Edwards Lifesciences’ premarket approval (PMA) application for the Sapien transcatheter heart valve on July 20. Edwards submitted a PMA application in the fall of 2010 based on data from the inoperable cohort (Cohort B) of the PARTNER Trial, for approval of this therapy in the treatment of inoperable patients with severe aortic stenosis.

June 10, 2011 — This year at the SNM 2011 Annual Meeting, Philips Electronics is announcing TruFlight Select, the first economical PET/CT system equipped with time-of-flight (TOF) technology. Although the TruFlight Select PET/CT is designed to serve the needs of facilities with budget constraints, the system is equipped with Philips’ premium TOF technology, Astonish TF. Astonish TF is the same TOF technology driving Philips’ new high-end Ingenuity TF PET/CT and PET/MR systems, introduced at RSNA 2010. Astonish TF is now being standardized across the Philips PET portfolio, and Philips is offering our current TOF customers a performance upgrade to the latest version of Astonish TF.

June 10, 2011 – The U.S. Food and Drug Administration (FDA) announced safety label changes for the cholesterol-lowering medication simvastatin because the highest approved dose – 80 milligram (mg) – has been associated with an elevated risk of muscle injury or myopathy, particularly during the first 12 months of use.

June 10, 2011 – The U.S. Food and Drug Administration (FDA) granted market clearance for a new vascular closure device (VCD) that uses a bioabsorbable plug to seal femoral artery puncture sites. The Cordis Exoseal VCD is indicated for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional catheterization.

June 8, 2011 – GE Healthcare is offering a new fully upgradeable SPECT technology that allows patient dose as low as 50 percent of those of standard nuclear medicine scanning protocols, or the potential for patients to spend significantly less time on the table during exams, all without compromising image quality.

June 8, 2011 — GE Healthcare announced the Optima PET/CT 560, which offers efficiency and investment protection with the capability to grow with the future needs of a clinical practice.

June 8, 2011 – Research introduced at the Society of Nuclear Medicine's 58th annual meeting this week may lead to much-needed cardiovascular disease screening for diabetic patients at risk of ischemic heart disease. The disorder is marked by significantly reduced blood flow in the heart. Ischemia of the myocardium can signal diminished oxygenation of the heart tissue and trigger a heart attack if left untreated.

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