Transforming FDA LogoFDA and AdvaMed today made public the agreement that should form the basis for the reauthorization of the Medical Device User Fee and Modernization Act (MDUFMA). The new user fee scheme will promote a 6.4% increase each year between FY 2008 and FY 2013. It significantly reduces application fees but adds two new fees. The details can be found in a notice of a public meeting to be held on April 30 for discussion of the topic. As expected, MDUFMA II eliminates the adjustments that made the year-to-year use fee increases so volatile. Instead, to promote more consistent funding, the proposal recommends two new fees...
April 16th, 2007
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Artificial hips are designed to last about 20 years at best. Yet, increasingly, they are being implanted in patients who will outlive the lifespan of their articificial hips. To make them last longer, there is a technique called resurfacing, which offers interim relief and allows doctors to delay the removal of the first artificial hip and the implantation of a new one. The first FDA-approved system, by Smith...
April 16th, 2007
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Teleflex Inc., parent company of Teleflex Medical (Limerick, PA), has acquired HDJ Co., Inc. (Lancaster, PA), parent company of contract manufacturer Specialized Medical Devices, reports the Philadelphia Inquirer. Terms of the agreement were not disclosed. Teleflex Medical sells sleep therapy, respiratory, anaesthesia, surgical instrument, and suture products, and also performs contract manufacturing. Specialized Medical Devices provides a full range of prototyping, engineering and testing services along with full scale production machining, assembly and contract packaging.
April 13th, 2007
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To better align resources for treating cardiovascular disease, Medtronic will combine its vascular and cardiac surgery businesses, according to a release published on devicelink.com. The company hopes the efficiencies created by the combination will allow it to invest more in research and development. The business will be called Medtronic Cardiovascular. It has four divisions and revenues of about $1.9 billion.
April 12th, 2007
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Thirty-five medical products have received Medical Design Excellence Awards, which reward companies for developing devices that are designed well and make a significant contribution to healthcare. You can read more about them in this month's edition of MD&DI, which is the publication sponsor of the competition. Winners will learn whether their products won gold or silver awards at a ceremony at MD&M East in New York City on June 13.
April 12th, 2007
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Becton Dickinson, the world's largest manufacturer of hypodermic needles, has been sued in federal court by a medical clinic accusing it of using its size to stamp out competition and overcharge for its products. The suit charges BD with violating federal antitrust laws through various illegal business practices to maintain a near monopoly in the hypodermics market, reports the Record of Hackensack, NJ. The suit was filed by the International Multiple Sclerosis Management Practice, based in New York City, and it seeks class action status. BD in 2004 paid $100 million to a competitor to settle charges of violating antitrust laws. A BD spokeswoman said the company believes it has broken no laws this time, and will fight the suit.
April 11th, 2007
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Nanotechnology is not only the latest buzz word in the device industry--many see it as the next frontier in medicine. With so many people trying to stake their claim in this potentially lucrative industry, the technology is experiencing a "patent goldrush," according to Chinh Pham. Pham, a patent attorney at Greenberg Traurig LLP (Boston), spoke at a MassMEDIC nanotechnology conference yesterday morning. Also head of the firm's nanotechnology practice, Pham advised attendees to patent aggressively by filing patents often and early to develop a strategic IP portfolio, provided they have the monetary support to do so. Companies should also be on top of their competition by searching the database on the U.S. Patent and Trademark Office's Web site. Finding trends based on issued patents and filings could be valuable information. Companies can take advantage of an opportunity by...

April 11th, 2007
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With MD...
April 10th, 2007
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Yes, as much as we wish it weren't true, corporate greed can be found in the medical device industry, too. The former CEO and CFO of Endocare, Inc. (Irvine, CA) have been indicted for their alleged participation in a scheme to fraudulently inflate company revenue, reports the Los Angeles Times. Paul W. Mikus and John V. Cracchiolo were charged with wire fraud, securities fraud, filing false statements with the SEC, and lying to the company's accountants. The indictment states that the executives in 2001 and 2002 reported false sales and underreported expenses to inflate earnings and show a history of consistent growth. It also says the company issued false public statements that an independent investigation had not uncovered any fraud, when in fact it had. Mikus and Cracchiolo left the company in 2003. They also face civil suits from the SEC. In 2006, the company signed an agreement with the...
April 10th, 2007
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Transforming FDA LogoCDRH has debuted a Web site that will keep the public informed about the status of studies mandated by the center as a condition of approval for certain medical devices. It will include all post-approval studies ordered by CDRH since Jan. 1, 2005. It is based on information reported by firms, who are required to update the center every six months during the first two years of a study, and every year thereafter. Each listing includes the company's name, the product's name, the approval number and date, and describes the study and whether it is meeting its reporting deadlines. Detailed information on clinical data is not...
April 9th, 2007
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