British authorities have issued a safety alert about a potential malfunction in implantable cardioverter-defibrillators made by Guidant, now owned by Boston Scientific, reports the Star Tribune of Minneapolis. The U.K.'s Medicines and Healthcare Products Regulatory Agency issued two advisories, one concerning potential delays in shocks and one concerning an erroneous signal that the battery is nearing the end of its life. No deaths have been reported but 31 devices have been prematurely removed from patients. FDA has not issued a similar warning in this country. While the news may not necessarily indicate that manufacturing problems are still pervasive for the Guidant devices, some doctors could take it that way. At home, FDA announced a Class I recall by HoMedics, Inc. (Commerce Twp., MI) of five heating-pad models that may short-circuit, causing...
March 20th, 2007
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Transforming FDA LogoFDA and industry know what they want out of MDUFMA II, as negotiations are just about complete. The stumbling block, however, is Congress. Congressional Democrats are unhappy with the pharmaceutical industry, and the device industry could get caught up in their wrath, TheHill.com reported in a feature last week. Congressional Democrats want to tie reauthorization of the pharmaceutical user-fee program to new drug safety requirements. MDUFMA is likely to be bundled with the pharma bill, which could lead to delays in its reauthorization as the pharma battle...
March 19th, 2007
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An article in today's edition of the New York Times is further evidence of the increased scrutiny that the medical device industry has been facing in recent times. The piece questions how device companies react to product malfunction and how they're perhaps not moving fast enough to pull these devices from the market. It also ties the failure to recall a product with the inability to properly track and analyze device-related complaints. In the advent of FDA's Postmarket Transformation Initiative and recent highly publicized recalls, companies need to make sure they have efficient and effective device tracking systems in place. The article in the Times cites the delay in the recall of a hernia patch, manufactured by Davol Inc., a subsidary of C.R. Bard. In this instance, Davol failed to "accurately" report the potential severity of the device complaints to FDA, and agency inspectors found "...
March 16th, 2007
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Are you part of a first-rate quality and/or regulatory team? Do you work with one? If so, why not give the team a chance for some recognition? Nominate the team today for MD...
March 15th, 2007
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Janet Moore gets it. It is all too common for industry to be completely left out of mainstream media pieces on medical innovations. Such stories often focus on the doctor and patient perspective and don't mention that without a company's R...
March 14th, 2007
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Boston Scientific may spin off its endosurgery unit, though it would retain control of the business, reports the Boston Globe. The firm's board is looking in to an initial public offering that would sell 20% of the endosurgery group, which would get its own name and corporate identity, to the public. Boston Scientific would retain control of the other 80%. The deal would be patterned after Nestle's 2002 spinoff of its Alcon eyecare business, in which the conglomerate raised $2 billion yet retained control of almost 77% of Alcon. Boston Scientific CEO Jim Tobin thinks the endovascular business is undervalued and that the partial IPO would rectify that. Given the controversies surrounding the products Boston Scientific inherited from Guidant and its own flagship product, the Taxus drug-eluting stent, he's probably right. Is this an admission by management that the...
March 13th, 2007
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When an FDA advisory panel convened in December to discuss safety issues of drug-eluting stents, many observers felt some sort of regulatory action would result. It has, but not in the way most expected. The biggest revelation from the meeting, which may become its most significant legacy, was the extent that stents are used off-label. That prompted Congress to begin an investigation into how they are promoted. And now, FDA is expanding a campaign to stop the promotion of stents for unapproved uses, reports Bloomberg News. Agency officials met yesterday with makers of heart and bile-duct stents to remind them of its guidelines about off-label promotion, most of which is not allowed.
March 13th, 2007
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British orthopedics giant Smith & Nephew plc is continuing its aggressive growth strategy. It has announced plans to buy Swiss ortho player Plus Orthopedics Holding AG for $889 million in cash, including assumed debt. This should boost Smith & Nephew's share in the orthopedic reconstruction market, especially in Europe. Plus primarily makes artificial hips and knees and has plants in Switzerland and China, both of which were coveted by Smith & Nephew. Smith & Nephew has made several acquisitions in the past year, and a few months ago made an unsuccessful play for American rival Biomet.
March 12th, 2007
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A professor at Purdue University not only recognizes the AIDS epidemic in Africa--he's doing something about it. In an extensive project that involves discussions with groups around the world, Paul Robinson, a professor at Purdue's schools of biomedical engineering and veterinary medicine, has taken the reins to develop a low-cost technology that will be used to perform medical testing on people with AIDS in Africa. The test detects CD4 cells, the cell count that provides the therapeutic monitoring of AIDS. Robinson and Gary Durack, president of iCyt, established Cytometry for Life, a program that is aiming to manufacture and deliver the low-cost devices to the most resource-poor countries. The cost of a CD4 test in Africa runs about $10 per patient. Robinson and Durack are aiming to build a device that can perform the test for about 50 cents per patient. Robinson told MD...
March 9th, 2007
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A research team at Ritsumeikan University in Japan has developed a prototype of a miniature robot that could be inserted into the body to perform medical procedures, reports Agence France-Presse. It weighs 5 g and measures 2 cm in length. It includes sensors, a camera, and a drug-delivery injector. It will surely be a while before we see this technology commercialized, but it seems to have great potential.
March 8th, 2007
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