The AdvaMed Emerging Growth Company Council (EGCC) announced the launch of its revamped Web site. It provides access to resources that help smaller, emerging companies succeed. These resources include issue-specific working groups, funding sources, conference calls, webinars, and expert advice from AdvaMed staff.
September 12th, 2008
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Physio Control Inc. (Redmond, WA), a division of Medtronic Inc., has recalled its LifePak CR Plus Automated External Defibrillator (AED). The problem with the device is that the shock button--which is pressed to deliver a shock that restores a normal heart rhythm--is covered and "invisible." Customers have been instructed to stop using the AEDs, or remove and get rid of the shock button cover. They were also informed that they would be receiving replacement AEDs.
September 12th, 2008
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Two studies published in the New England Journal of Medicine indicate that arthroscopic knee surgery is performed more often than it needs to be, particularly on arthritis patients, reports the Associated Press. One found that surgery worked no better than medication and physical therapy in regards to relieving pain and stiffness from moderate or severe arthritis. Another found that tears in knee cartilage, which often prompt the decision to have the surgery, often do not cause symptoms. Two-thirds of study participants who had knee cartilage tears reported no pain or stiffness in the prior month. The authors said the procedure can benefit those with large tears, recent injuries, or milder symptoms. But it should not be performed routinely on osteoarthritis patients. During the procedure, a scope with a miniature camera is inserted through a tiny incision and surgeons operate through...
September 11th, 2008
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The Association for the Advancement of Medical Instrumentation (AAMI) is designing a course on human factors considerations during design, manufacture, and post-market of medical devices. It will be designed for professionals working in or for medical device manufacturers that already have a basic understanding of the framework of quality management systems, particularly design control, risk management and CAPA activities, but need more in-depth information about the concepts, science, processes, methodologies, and practical applications of human factors. AAMI is asking people in the device industry to give input on what the course content and curriculum should be. To that end, it has set up a survey. To take the survey, go here.
September 10th, 2008
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FDA has approved the PAS-Port system from Cardica Inc., reports the Associated Press. The system is used to create a secure connection between the body's main artery and vein grafts during cardiac bypass surgery. That connection enables a damaged or blocked artery to be bypassed. Shares of Cardica rose more than 25% after the approval was announced.
September 10th, 2008
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Adults with Type 1 Diabetes who use continuous glucose monitors are better able to keep their blood glucose at reasonable levels than those using traditional blood meters, according to a study published on the New England Journal of Medicine's Web site. During the life of the 26-week study, adults (defined as those 25 and over) using continuous glucose monitors saw their blood glucose levels drop by an average of 0.5%, reports the Wall Street Journal. However, adults in the study who used traditional blood meters saw their blood glucose levels rise slightly during that time. If blood glucose levels drop 1%, that reduces the chance of future complications from diabetes by 40%. The same effect was not observed in children, because they were not as compliant about wearing their continuous monitoring...
September 9th, 2008
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Analog Devices Inc. has unveiled a pair of eight-channel ultrasound receivers that are expected to improve image quality and power efficiency for cart-based and handheld ultrasound systems. One, the AD9272, is for cart-based systems. It has a lower level of terminated noise than previous receivers, which enables better image quality. The other, the AD9273, is the most power-efficient receiver for ultrasound systems, making them a fit for handheld systems, where efficient battery operation is so crucial. Both feature a serial port interface that allows system designers to customize the noise and power performance for any given imaging mode, probe, or power requirement. "One of the things we've been able to do is greatly reduce the...
September 8th, 2008
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Spectranetics was named one of MD&DI's 50 Companies to Watch in 2006. Apparently the federal government was watching them, too. The cardiovascular device maker said its Colorado Springs, CO offices were searched by FDA and U.S. Immigration and Customs Enforcement, Reuters reports. The investigation concerns the sales and marketing practices related to certain products, as well as payments made to medical personnel who took part in the firm's clinical studies. The feds are also seeking information on two postmarket studies conducted from 2002 to 2005 and payments made to personnel in connection with those studies, as well as on compensation packages for certain company employees. Spectranetics says it is cooperating with the investigation, and does not expect business to be disrupted.
September 5th, 2008
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Zimmer Holdings has announced its plans to buy Abbott Laboratories' spine division. The $360-million deal should be completed by this year's fourth quarter. Zimmer's spine business reached $197 million in sales last year, only five percent of its total sales. Abbott Spine hit $109 million in 2007, which is a very small portion of its total drug and device sales revenue of $25.9 billion. David Dvorak, Zimmer's CEO, said the acquisition will strengthen the company's sales scope, product pipeline, and add to its R&D capabilities.
September 5th, 2008
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A study published in today's New England Journal of Medicine revealed that heart failure patients were five times more likely to die within four years of receiving a defibrillator zap to the heart to restore a normal rhythm than patients who didn't get a shock. And for patients who didn't need a shock but still received one--their risk of dying doubled. Progressive heart failure was the most common cause of death in patients whose hearts were shocked. The president of the Heart Rhythm Society, N.A. Mark Estes, MD, pointed out that the devices used in the study are much older than current devices that use pacing methods to correct abnormal heart rhythms before administering a shock. There's no denying that defibrillators can have a significant effect on extending life. Another study published in the same issue of the journal concluded that after 30 months...
September 4th, 2008
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