Yesterday FDA classified the recall of Baxter Healthcare's 66 Colleague brand infusion pumps as a Class I recall, according to the Associated Press. The devices were recalled last month after the company found that a service technician didn't perform hardware upgrades related to eight open Colleague recalls. A company spokesperson stated that Baxter has replaced or repaired the affected devices.
September 26th, 2007
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A federal judge in Delaware failed to throw out a jury's verdict that the company's Cypher stent infringed on a Boston Scientific patent that covers drug coatings. The New York Times reports that this move goes against the strategy of J&J's lawyers, who were trying to convince the judge that since Cypher was linked to blood clots in clinical studies, it must fall outside the safety profile of Boston Scientific's patent. According to the article, Judge Sue Robinson made the final verdicts yesterday, and both companies will be moving forward to appeal the verdicts against them to the U.S. Court of Appeals in Washington, DC.
September 25th, 2007
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Newer types of artificial lungs could give patients with illnesses such as lung disease a chance to live longer. An article in the LA Times reports on prototypes being developed around the country that are using better materials, surface coatings, and help manage blood clotting. Some devices can be used for weeks or months, while others are designed to partially replace lung function. One professor at the University of Michigan received a $5 million grant to develop an artificial lung that would take over lung function and use the heart to serve as the pump. Although these devices will need extensive research and clinical trials (if they even make it to that point), the technologies show significant promise for patients who can't take breathing for granted.
September 24th, 2007
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Canon Communications LLC has announced a new Medical Design & Manufacturing (MD&M) Midwest show that will be held in Rosemont, Illinois next year. Canon, publisher of MD&DI, has annual MD&M tradeshows located in Anaheim, New York City, and Minneapolis. According to the company's senior vice president of events, Kevin O'Keefe, the fives states surrounding the show make up a $20 billion marketplace for medical device manufacturing. MD&M Midwest will be held in September 2008. The show, which will also include a conference lineup, is expected to draw 300 exhibiting companies and 4000 medical design and manufacturing professionals.
September 21st, 2007
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Transforming FDA LogoThe House yesterday passed a House-Senate compromise version of read more >>
September 20th, 2007
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It's not every day that you see a mainstream media piece that goes into detail about a particular regulatory process. But today's Boston Globe has a piece that explains in depth the Humanitarian Device Exemption (HDE) process. It is doing so because a Massachusetts company is applying for an HDE for its device that tries to regenerate spinal nerve cells. The Andara Oscillating Field Stimulator System from Cyberkinetics Neurotechnology Systems Inc. (Foxborough, MA) delivers electrical pulses to the spine to try to make it regenerate nerve cells. The article also talks about how the HDE process worked for another Massachusetts company, Abiomed Inc., whose application for its Abiocor artificial heart was successful. Whether Cyberkinetics can have the same success, we don't know. The piece quotes one researcher who seems to liken the company to a snake-oil peddler....
September 18th, 2007
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Doctors Alain Carpentier and Albert Starr, who were pioneers in the development of prosthetic heart valves, are among read more >>
September 17th, 2007
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A study in the British journal The Lancet says that patients who receive drug-eluting stents are no more likely to die than those who receive bare-metal stents, reports the New York Times. That could temper fears about blood-clotting risks. Or maybe not. Once a negative message gets out there, it's hard to make it go away. The study does have negative news for Boston Scientific: It says that patients with Taxus are more likely to suffer heart attacks than patients with J&J's Cypher. It also says that Taxus patients are slightly more likely to get blood clots than patients with Cypher or bare-metal stents.
September 14th, 2007
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Edwards Lifesciences announced a $5 million multi-year grant to the University of California-Irvine to establish a center for researching and developing the next generation of cardiovascular devices. The center will reside in the Henry Samueli School of Engineering and will be called the Edwards Lifesciences Center for Advanced Cardiovascular Technology, according to a release published on devicelink.com. It will incorporate graduate and undergraduate programs having to do with heart and cardiovascular diseases. It will be housed in a new building scheduled for completion in August 2009.
September 13th, 2007
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