June 19, 2008 - Biopure Corp. said this week the U.S. Naval Medical Research Center (NMRC) submitted a new protocol for review by the FDA for a Phase 2 clinical trial of Hemopure (hemoglobin glutamer - 250 - bovine), or HBOC-201, for resuscitation of casualties with severe traumatic hemorrhagic shock without availability of blood transfusions. The proposed trial hypotheses is that for such casualties Hemopure substitute blood will improve survival and other clinical parameters, and will be relatively safe and well tolerated, in comparison with standard fluid.

June 19, 2008 – HemoCue AB, a point-of-care diagnostic test manufacturer and wholly owned subsidiary of Quest Diagnostics Inc. said its HemoCue Albumin 201 System is the first quantitative point-of-care test for screening, diagnosing and monitoring microalbuminuria to be granted a CLIA waiver by the FDA.

June 18, 2008 – Bracco Diagnostics showcased its Cardiac PET Perfusion Imaging with CardioGen-82, a Rubidium Rb 82 generator and emphasized the advantages of cardiac PET Perfusion Imaging over the current SPECT, at the Society of Nuclear Medicine's 55th Annual Meeting.

June 18, 2008 - New imaging software that will allow physicians to more accurately diagnose and treat heart failure patients has been licensed by Emory University to Syntermed, an Atlanta-based nuclear medicine imaging and informatics software company.

June 18, 2008 - Researchers using positron emission tomography (PET) are able to see changes in coronary blood vessels, offering hope that those at risk of cardiac deaths caused by disease in the heart’s vessels can receive earlier treatment and prolong life.

As many as 50 percent of all cardiac deaths due to disease in the heart’s vessels occur in individuals with no prior history or symptoms of heart disease. In addition, standard coronary risk factors may fail to explain up to 50 percent of cardiovascular events.

June 18, 2008 - Imaging3 developed and patented a new technology called Dominion that utilizes high-resolution photo-fluoroscopy to produce three-dimensional medical diagnostic images in real- time, reportedly allowing them to be used for any current or new medical procedures in which multiple frames of reference are required to perform medical procedures on or in the human body.

June 18, 2008 - NeoMend Inc. today said its ProGEL Surgical Sealant received a recommendation for approval from the FDA’s Anesthesiology and Respiratory Therapy Devices Advisory Panel.

The panel’s recommendation will be considered by the FDA during completion of its review of the premarket approval for ProGEL. The panel’s recommendation for FDA approval was conditioned principally on NeoMend conducting a post approval study to gather more safety data.

June 18, 2008 – Biotronik GmbH launched the Lumax 540 series, which includes implantable cardioverter defibrillators (ICDs) and a cardiac resynchronization therapy defibrillator (CRT-D), which is used with Biotronik Home Monitoring to enable continuous automatic daily data transmission of the patient’s cardiovascular status.

June 17, 2008 - The FDA has cleared Medtronic Attain StarFix OTW (over-the-wire) lead (Model 4195), an active fixation left-heart lead for cardiac resynchronization therapy (CRT).

The Attain StarFix lead, according to the manufacturer, overall, including the acute dislodgements at one day post-implant, has had a low 0.7 percent dislodgement rate. These dislodgement rates are supported by one of the industry’s largest and longest-running left-heart lead clinical studies involving 385 implants followed for up to four years.

Toshiba America Medical Systems’ Infinix Hybrid cardiovascular X-ray imaging system will be featured in three live cases during the International Symposium on the Hybrid Approach to Congenital Heart Disease (ISHAC), June 16 – 18, 2008. In the first case, codirectors of The Heart Center at Nationwide Children’s Hospital will perform a hybrid procedure on a one day old baby with hypoplastic left heart syndrome via live simulcast using Toshiba’s Infinix Hybrid system. John P. Cheatham, M.D., director of cardiac catheterization and Interventional Therapy and Mark Galantowicz, M.D., chief of cardiothoracic surgery will complete this procedure.

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