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October 7, 2011 — U.S. Food and Drug Administration (FDA) Commissioner Margaret A. Hamburg, M.D., released a blueprint containing immediate steps to drive biomedical innovation, while improving the health of Americans.

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October 7, 2011 — Boston Scientific Corp. has started patient enrollment in the Omega clinical trial, designed to evaluate the company's Omega platinum chromium bare-metal coronary stent system. The trial will test the safety and effectiveness of OMEGA in treating patients with a single coronary artery lesion.

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October 7, 2011 — Biosensors has announced completion of its acquisition of JW Medical Systems Ltd. (JWMS), one of the top three suppliers of drug-eluting stents (DES) in China.

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Feature | Helen Kuhl

Although computerized physician order entry (CPOE) systems have been around for a few years, only a few vendors really embraced the market with robust offerings and only a few healthcare providers showed interest in adopting them — until the 2009 passage of the American Reinvestment and Recovery Act (ARRA). After that, the landscape changed considerably, as many providers wanted to take advantage of reimbursements available in meeting meaningful use (MU) requirements and the rate of adoption grew significantly.

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October 6, 2011 – Cambridge Heart Inc. announced it has concluded data review for the company’s microvolt T-wave alternans-computer-aided detection (MTWA-CAD) feasibility study. The data suggest MTWA is a statistically significant predictor of ischemic events. In addition, the data revealed instances where the company's MTWA test identified underlying coronary artery disease that was not identified by other standard diagnostic modalities.

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Technology

During RSNA 2011, Infinitt will showcase its latest advances in image and information management across the enterprise.

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Abbott began enrolling U.S. patients in the EXCEL trial, which will compare the use of the Xience Prime or Xience V drug-eluting strents to coronary artery bypass graft (CABG) surgery for effectiveness of left main revascularization. The large-scale trial will attempt to show stenting has comparable or superior outcomes to CABG, which has long been the dream of interventional cardiology.

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October 4, 2011 – Roche announced plans today to expand its coagulation testing product line in North America beyond physician offices and outpatient clinics with the development of a full line of coagulation analyzers for hospital and reference laboratories. The new line is expected to be introduced in the United States and Canada in 2014, subject to regulatory approval and other requirements.

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October 4, 2011 – The International Contrast Ultrasound Society (ICUS) submitted a petition this week to the U.S. Food and Drug Administration (FDA) requesting removal of the boxed warnings on ultrasound contrast agents. The members of the group say this would bring the product labeling into line with the current body of scientific research, which it says clearly demonstrates the safety and clinical benefits of these imaging products.

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Toshiba America Medical Systems will showcase the Infinix VF-i bi-plane angiography system with dual 12”x12” mid-size ...

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October 3, 2011 – Maquet Cardiovascular has signed a definitive agreement to acquire Atrium Medical Corp. for $680 million. Atrium is a medical device technologies developer for interventional cardiology and radiology, chest trauma care and thoracic drainage, vascular surgery and general surgery. Atrium will operate as an independent, self-contained business unit of Maquet and will be led by current Atrium president Trevor Carlton.

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October 3, 2011 —The American Society of Echocardiography (ASE) has published guidelines for new applications for echocardiography in the neonatal intensive care unit (NICU). An expert consensus statement, “Targeted Neonatal Echocardiography in the Neonatal Intensive Care Unit: Practice Guidelines and Recommendations for Training,” has been published in the October 2011 issue of JASE, the ASE’s monthly journal, and is also available online at: www.asecho/guidelines. The document defines the scope and appropriateness of echocardiography in the NICU and defines standards for both the echocardiographic examination and the individuals who perform and interpret these studies.

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October 3, 2011 — Kjaya Medical will debut iShareScan.com, a cloud-based image sharing solution, at RSNA 2011. The site is available at no cost to imaging sites. It enables users to upload images to the Kjaya cloud, where they may be accessed, viewed and manipulated instantaneously in 2-D, 3-D or 4-D by authorized physicians utilizing the company’s advanced remote viewer.

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October 3, 2011 – Up to now, on-the-job hazards for cardiac sonographers were usually limited to overtaxed muscles or incorrect body positioning. And the profession, with help from equipment manufacturers, has made remarkable progress in identifying and lessening these problems. But now, based on discussions initiated on the American Society of Echocardiography’s (ASE) social media website, [email protected] and results of an ASE survey, there appear to be growing concerns about radiation exposure. As October is Medical Ultrasound Awareness Month, the ASE believes it is appropriate to address this emerging concern for cardiovascular sonographers. Are sonographers getting more radiation on the job than is acceptable for their health?

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October 3, 2011 — JenaValve Technology GmbH, a German medical device company specializing in the development of transcatheter heart valve implantation (TAVI) systems, announced it has received CE mark approval for its transapical TAVI system of the second-generation. This system is used to treat severe aortic valve stenosis in elderly high-risk patients, especially in patients for whom conventional open-heart surgery is not an option.

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