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In an attempt to enhance what it considered a sluggish nationwide response to the Institute of Medicine's calls for reducing error and improving patient outcomes in hospital care, the Institute for Healthcare Improvement (IHI) initiated in 2004 an ambitious, highly visible, 18-month program.
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The term "dementia" refers to central nervous system (CNS) pathology that makes it hard for a person to remember, learn, and communicate. It may also involve perception, emotional behavior, and cognitive skills. Usually, dementia presents as forgetfulness, but may eventually lead to disruptive behavior.
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Largely at the prodding of industry, FDA has pondered whether it should grant device makers greater leeway in the use of clinical trials other than the gold standard of randomized, controlled trials (RCTs).
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The era of second-generation drug-eluting stent (DES) technology moved one step closer to reality last month with a recommendation to the FDA by its cardiovascular system panel to approve the Endeavor DES from Medtronic (Minneapolis).
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As surely as night follows day, the lawsuits began lining up against. Medtronic (Minneapolis) shortly after the reports of the company's recall of its Sprint Fidelis defibrillation leads in mid-October.
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It's a rather famous fact that patients frequently don't take the drugs they're prescribed and don't even have them filled at the pharmacy.
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Cardiogenesis (Irvine, Califonrnia), a developer of surgical products for transmyocardial revascularization (TMR) reported FDA approval of its PEARL (Port Enabled Angina Relief using Laser) 5.0 Robotic Delivery System.
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CVRx (Minneapolis) last month received the CE mark for its Rheos Baroreflex Hypertension Therapy System, which it said is the only implantable device designed to control hypertension.