FDA has approved a test that can detect West Nile Virus in donated human blood and plasma. Manufactured by Roche Diagnostics, the test is only one of two on the market that can screen donated blood for the virus. Although most infections are spread via the bite of an infected mosquito, the first transfusion-transmitted infection of the virus was detected in 2003, according to Roche. Most people infected with West Nile don't get sick either or only have mild symptoms. One advantage to the Cobas TaqScreen West Nile Virus Test is that it can detect the virus earlier in the infection cycle in donors who might not show any symptoms. A similar test made by Gen-Probe Inc. (San Diego) was cleared by FDA in 2005.
August 29th, 2007
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In recent years there has been a push to put portable defibrillators in schools. But a study published yesterday suggests that the effort may not be worth the cost, reports the Associated Press. The study looked at emergency response to schools in the Seattle area between 1990 and 2005. Only 12 times during that period did a student suffer cardiac arrest; all other incidents involved adults. The defibrillators tend to cost between $1000 and $3000, not including the cost of training. Some schools have trouble affording that. Schools are required to identify students with health problems who may require an emergency response. The results of that assessment could now form the basis of the decision whether to make the investment in a defibrillator.
August 28th, 2007
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The British government is considering a proposal to end reimbursement for drug-eluting stents because of safety concerns, the Associated Press reports. If the policy is adopted, patients would be forced to either settle for bare-metal stents or other treatments, or pay for drug-eluting stents out of their own pockets. The British and European cardiology societies are fighting the proposal, with good reason. Withdrawing reimbursement would send the message that drug-eluting stents are dangerous devices. The evidence gathered so far does not support that. The move would create panic among patients who already have the devices implanted, and deter most from considering getting them implanted. That's only appropriate when a device's risks far outweigh its benefits -- which is not the case here.
August 28th, 2007
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The University of Chicago Medical Center has hired one of the foremost experts in robotic surgery in an effort to make it more widely available for coronary bypasses, reports the Chicago Tribune. This is another triumph for Intuitive Surgical, which makes the systems. Indeed, the company is supporting the initiative, and believes that a better way to do bypass is increasingly necessary, given recent studies that have identified problems with angioplasty and stenting. (Unfortunately, the company isn't mentioned until well into the article's second page.) There is some skepticism about whether robotic surgery is better than conventional surgery when it comes to bypass, and the cases for both sides are made well in the article.
August 27th, 2007
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There's been a whirlwind of activity at Boston Scientific this summer, and it hasn't all been good. The company is fighting debt and in the past month alone has announced plans to sell three of its entities--its vascular and cardiac surgery units, along with part of Advanced Bionics. In efforts to cut costs, it's considering making job cuts as well. Now, as Boston Scientific tries to get back on track, it has negotiatied loan agreements and made a $1 billion early loan payment. The prepayment was made on a $5 billion term loan. According to the comapny's CEO, Jim Tobin, the payment should provide "significant financial flexibility."
August 24th, 2007
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Transforming FDA LogoFDA is reviewing more than 300 positions in 20 cities to see whether they could be outsourced to private companies, the Associated Press reports. The original position list included lab technicians and field office workers at facilities where devices are inspected for safety. But it was then revised to include only administrative positions. The National Treasury Employees Union is asking Congress to oppose the plan. And it may succeed; it was lobbying by the NTEU that nixed the agency's plan to close seven of its 13 field laboratories. If administrative jobs can be done cheaper and better by the private sector, then the outsourcing plan should be...
August 23rd, 2007
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Medtronic is one of the unquestioned top companies in the device industry. It pioneered cardiac rhythm management and plays in many of the most lucrative device markets. Yet, despite all its successes, its share price has lagged in recent years, because while the firm has shown growth, it has not made the numbers predicted by its executives or Wall Street analysts. The New York Times today has a fascinating look into read more >>
August 22nd, 2007
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The government over the weekend announced that read more >>
August 21st, 2007
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Titanium oxide-based ceramic nanowires might be a more effective coating for medical devices. Researchers at the University of Arkansas have created the coating for the surface of biocompatible titanium in applications such as hip replacements and vascular stents. Since the length, height, and pore size can be controlled in the nanowire scaffolds, the coating could also prevent implant degradation. The research suggests that the coating could be used in stents to carry drugs that would keep arteries open longer than current drug-eluting stents. When the material is rinsed in water and exposed to UV light, it also kills more than 99% of surface bacteria, making it useful for performing sterilization in hospitals.
August 20th, 2007
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Boston Scientific said it will consider selling its cardiac and vascular surgery units as a way to lighten its debt load, the New York Times reports. The cardiac surgery unit came as part of the Guidant acquistion. The vascular surgery unit came as part of a 1995 acquisition. The company believes it could get about $600 million for them.
August 17th, 2007
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