Transforming FDA LogoThe Senate yesterday shelved a controversial amendment that could have impeded the enaction of the bill that includes the new version of MDUFMA, the Los Angeles Times reports. The amendment has nothing to do with devices -- it would have allowed drug reimportation, and its inclusion likely would have prompted President Bush to veto the whole thing. Whether drug reimportation would have been a good or bad thing is not our concern here. What's important is that the move by the Senate means there is one less obstacle toward MDUFMA II becoming a reality.
May 8th, 2007
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Johnson & Johnson announced it will stop selling its Costar II stent worldwide, and cease seeking FDA approval for it, after trials showed it performed worse than a competitor, reports Bloomberg News. Costar became a J&J product after it acquired Conor Medsystems and the move is a major short-term blow. A head-to-head trial against Boston Scientific's Taxus showed that 11% of patients on Costar had a heart attack, needed a repeat procedure, or died within eight months, vs. 6.9% for Taxus. J&J executives appear to be blaming the drug used with Costar, and the firm will try to redevelop it using sirolimus, the drug used with J&J's Cypher.
May 7th, 2007
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St. Jude Medical announced that it has received FDA approval and a CE mark for a new family of pacemakers, the Zephyr, according to a release posted on devicelink.com. Zephyr is the first pacemaker that can tell doctors the optimal timing settings for each patient. This occurs in 90 seconds, in contrast to an echocardiography procedure which takes between 30 and 120 minutes. It also automatically performs follow-up testing and stores the results.
May 7th, 2007
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President Bush has announced his intention to nominate Kerry Weems as the new administrator of CMS. Weems is currently the deputy chief of staff at the Department of Health and Human Services. Although Weems has been a trusted adviser to HHS Secretary Michael Leavitt on budget matters related to federal health spending, it's unusual for such a federal employee to be nominated to a top political position, the Associated Press notes. Still, advocates of Weems say his experience will put him in a good position to run CMS. If the Senate confirms the nomination, Weems would take Mark McClellan's place, who resigned last fall. Leslie Norwalk has been serving as acting CMS adminstrator since. Bush will also reportedly nominate Tevi David Troy to serve as deputy secretary at HHS.
May 4th, 2007
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Orthopedics giant Smith & Nephew will be losing its CEO, Christopher O'Donnell, to retirement in June. O'Donnell has been head of the company for 10 years and will step down as director at the end of July. Current COO David Illingworth will replace O'Donnell. Smith & Nephew is also moving forward with a program that it hopes will lower costs, improve efficiency, and drive profits to $150 million by 2010. It's anticipated that more than 100 people could lose their jobs as a result. Despite its growth plan, the company is still considered a medium sized company next to Stryker and Zimmer.
May 4th, 2007
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May 3rd, 2007
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Lawrence Best, CFO of Boston Scientific and one of the architects of the Guidant merger, will resign effective July 6, reports the Boston Globe. Best had been in his position for 15 years and helped oversee the company's transformation from niche catheter manufacturer to global powerhouse. He had a much higher profile than the average medical device CFO, thanks to engineering 37 acquisitions and regularly making himself available to analysts and the media. He will be replaced by Sam Leno, who is leaving his CFO position at Zimmer Holdings. Zimmer went through its own management shakeup this week, naming David Dvorak to replace retiring CEO Ray Elliott and James Crimes to replace Leno. Boston Scientific was also impacted by another executive move this week. Daniel Moore, a senior sales and marketing executive,...
May 2nd, 2007
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Transforming FDA LogoMedical device companies are fine with paying higher user fees as long as it leads to a more predictable, streamlined process, reports the Record of Hackensack, NJ. "Enactment will help ensure that the agency has the resources necessary to fully evaluate medical device and diagnostic innovations and provide patients with timely access to medical technologies that can improve and save lives," a Becton Dickinson spokeswoman told the paper. Yesterday's public meeting on MDUFMA II did not produce any news of significance, according...
May 2nd, 2007
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A study published in the journal Circulation reveals that one in five implantable cardioverter-defibrillators stop working properly after 10 years, reports Bloomberg News. The biggest culprit is malfunctioning leads. Data from the study show that failure rates rose with time and affected all models. As of this morning, the companies that make ICDs had not responded to the findings. Until better lead technology is invented, might we have to look at ICDs like we do artificial hips -- a technology with a shelf life that must be replaced if the patient outlives it?
May 1st, 2007
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In ruling on a case called KSR v. Teleflex, the U.S. Supreme Court today struck down its previous standard of "obviousness" and came up with a new standard that is expected to make it harder to obtain patents and easier to challenge their validity. The medical device industry, much of whose value derives from patents, needs to take note. The San Francisco law firm Morrison...
April 30th, 2007
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