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Articles from 2007 In August

Oximetry Catheter for Critically Ill Children Introduced

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.

FDA Approves West Nile Virus Blood Test

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.

Study: Not All Schools Need Defibrillators

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.

UK May Cease Paying for Drug-Eluting Stents

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.

Another Boost for Robotic Surgery

(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.

Boston Scientific Tries to Get Back on Track

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."

FDA May Outsource 300 Jobs

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 considered. But outsourcing technical people is probably not an avenue that should be traveled.

Why Can't Medtronic Keep Wall Street Happy?

The New York Times today has a fascinating look into why clinical success has not translated into stock market success. The article comes as Arthur D. Collins Jr. prepares to step down as CEO tomorrow, handing the reins to William A. Hawkins. The problems, it seems, are overoptimistic timetables and forecasts, delays in getting new products to market, and slow sales of implanatble cardioverter-defibrillators (partly as a result of publciity about recalls). Indeed, just yesterday Medtronic said that it expects FDA to approve its Endeavor drug-eluting stent by the end of the year. Yet analysts don't seem to believe that. Also yesterday, Medtronic reported first-quarter income that was more than 12% higher than the same period last year, and revenues 8% higher than a year ago. Yet its share price fell again because it failed to meet analyst estimates. And the analysts don't make up their estimates out of thin air -- they are based on information from the company. Faith in your company's outlook is a good thing. But misplaced faith or overoptimism by company executives will not play well on Wall Street. That's a lesson Hawkins needs to apply immediately.

A Financial Incentive to Avoid Errors

CMS also will not pay for the treatment of "serious preventable events" like leaving a sponge in a patient during surgery or providing a patient with incompatible blood or blood products. In many aspects of life, the best way to deter behavior is to hit those who commit it in the wallet. That's what CMS is hoping will work here. Private insurers could well follow. If human nature holds true and the new policy prompts fewer misuses of devices and cuts down on other errors, then many lives and dollars could be saved. The healthcare system is vast and slow to change, so it's not a guarantee that the new policy will achieve its goal, but it's worth a try.

Nanowire Coats Implants and Stents

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.