The New York Times reports that the Senate introduced a bill today aimed at tightening the rules surrounding payments and gifts to doctors. What is particularly interesting is that the article emphasizes that this bill includes medical device manufacturers. And, the list of gifts and benefits that must be diclosed is more comprehensive than any state measure introduced to date. According to the Times, "Companies with at least $100 million in annual revenues would have to make quarterly disclosures of gifts or payments that exceed $25, and the reports would be posted on a Web site." Device companies are no longer under the radar when it comes to such payments, and this bill may be the one that brings about permanent change in such practices.

September 7th, 2007
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Analysts and physicians interviewed by Bloomberg News expect that by 2009, Abbott and Medtronic read more >>
September 6th, 2007
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September 5th, 2007
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A Swedish study, based on a patient registry, found that clotting issues related to drug-eluting stents are not as frequent as previously thought. A respite for Boston Scientific and Johnson & Johnson, right? Not so fast. Yesterday another registry-based study was made public which found that drug-eluting stents are linked to higher death rates for patients who have suffered a certain kind of heart attack, reports Bloomberg News. While better than consistently bad results, conflicting results don't help a device's prospects, as doctors and patients may turn cautious about its use, whether because of conservatism or confusion. J&J issued a statement saying the new study's results should not be heeded because they are out of line with other study results. But that message may not get through, given the noise that's been introduced into the debate.
September 5th, 2007
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This has been a banner year for blockbuster device industry deals. Over the holiday weekend, device suppliers got into the act, too. Signapore's Flextronics International Ltd. acquired Avail Medical Products Inc. (Fort Worth, TX), one of the leading contract manufacturers to the device industry. Financial terms were not disclosed. This comes just after Flextronics' $3.6 billion purchase of contract electronics manufacturing firm Solectron Corp. received approval from European regulators. The two deals signify Flextronics' desire to become a major player in the medical device industry. Meanwhile, GE read more >>
September 4th, 2007
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Edwards Lifesciences announced in a release on devicelink.com that it has introduced the first real-time, continuous central venous oxygenation saturation monitoring technology for critically ill children. The Edwards PediaSat Oximetry Catheter uses fiber optics to monitor and identify potentially life-threatening changes in oxygen saturation in venous blood. Up until now, such technology was only available for adults. But children are even more in need of it, because they sometimes do not display the typical warning signs of potentially fatal issues. Before, physicians had to rely on intermittent blood sampling, which is less reliable and less convenient. DeviceTalk will return on Tuesday, September 4.
August 30th, 2007
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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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