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A proposed Centers for Medicare & Medicaid Services (CMS; Baltimore) national coverage decision involving Cambridge Heart's (Bedford, Massachusetts) Microvolt T-Wave Alternans (MTWA) cardiac diagnostic testing may have far-reaching impact across a substantial swath of the cardiovascular device sector.
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Affymetrix (Santa Clara, California) reported entering into a five-year collaboration with Duke University (Durham, North Carolina) to analyze genomic information across large patient samples. Duke researchers will use Affymetrix GeneChip microarray technology to develop new applications for translational research projects. The initial projects will focus on cancer and cardiovascular disease.
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Daniel Sutherby joined Abiomed (Danvers, Massachusetts) as CFO. He previously was with PerkinElmer, most recently as corporate vice president, investor relations, corporate communications and risk management.
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Roche Diagnostics (Indianapolis) has received FDA clearance for what the company says is the first and only natriuretic peptide test to be green-lighted by the FDA for risk assessment of cardiac events in people with stable coronary artery disease. The company said that nearly 13 million people in the U.S. have stable coronary artery disease, making them more susceptible than the general population for the development of adverse cardiac events.
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In the wake of the multitude of recalls in 2005 of implantable systems - primarily pacemakers and implantable cardioverter defibrillators - the FDA's Center for Devices and Radiological Health in January unveiled an intensified effort for the post-market surveillance and reporting of problems with all medical devices.
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Doxycycline Hyclate 20 mg Tablets and Metronidazole 0.75% Topical Lotion in the Treatment of Rosacea; Left Atrial Radiofrequency Ablation During Mitral Valve Surgery; Comorbid Depression with Mortality in Patients with DM; Risk of Death in Elderly Users of Conventional vs Atypical Antipsychotic Medications; Beta-Blockers to Prevent Gastro-esophageal Varices in Cirrhosis Patients; Effects of Protein, Monounsaturated Fat, and Carbohydrate Intake on Blood Pressure and Serum Lipids
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Rebbeck and colleagues identified a cohort of 462 women with BRCA1/2 mutations from 13 medical centers in North America and Europe.
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It has become increasingly documented that removal of the ovaries in high-risk women can not only reduce the risk of gynecologic malignancy but also improve the outcome of women with breast cancer.
