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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A bill to modernize Medicare's reimbursement system for diagnostic tests was reintroduced into the House this week, with strong support from AdvaMed. The Medicare Advanced Laboratory Diagnostics Act would, among other things, foster the creation of a new payment system for molecular diagnostics, provide more transparency on reimbursement decisions, timely correct payment errors, and improve processes for adequate reimbursement of new tests. AdvaMed and the bill's bipartisan supporters claim that the current Medicare system does not recognize the value of genetic-based tests and provides a disincentive to develop new tests. The bill was first introduced in May 2006 but did not get anywhere then.
March 7th, 2007
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The House Committee on Oversight and Government Reform has subpoenaed documents from Boston Scientific and Johnson...
March 6th, 2007
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Transforming FDA LogoAs of this morning, details of the MDUFMA reauthorization agreement between FDA, Congress, and industry had not yet been released, but AdvaMed president Stephen Ubl shed some light on them at last week's American Institute for Medical and Biological Engineering annual meeting. He shared three points: 1. "We are reducing fees across the board for applications -- whether PMAs or 510(k)s." 2. "The year-to-year increases will be more predictable. There will be no more compensation adjustment, which made the system more volatile." 3. "We estimate that the new goals will bring performance improvements for FDA reviewers and significantly reduce review times." He also noted that "other...
March 5th, 2007
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Daylight Savings Time gets longer this year. A federal law passed in 2005 extending it by four weeks in order to save energy goes into effect this month. That means it will begin on March 11 instead of April 1, and end on November 4 instead of October 28. However, medical devices and related equipment may not have the new information programmed in, and FDA is concerned about whether that will affect functionality. It has put out an advisory to caregivers and hospital personnel and one to patients to make them aware of potential problems. Device manufacturers may be getting a lot of calls about this over the next nine days.
March 2nd, 2007
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Yesterday, Medtronic CEO Arthur Collins Jr. announced that he will be stepping down at the company's annual shareholder meeting in August. William Hawkins, the company's president and COO, will then take the reins as president and CEO. Collins has been with the device giant since 1992 and became CEO in 2001. He'll  continue to serve as director and chairman of the board until August 2008. During Collins' time as CEO, Medtronic's market capitalization grew from $53.5 to $58 billion, according to the Star Tribune. Hawkins will take on the challenge of growing the company's existing businesses that manufacture devices to treat diabetes, heart disease, and spinal and neurological conditions. He'll also have to deal with the controversial issues surrounding defibrillators, as industry recalls have resulted in a "sharp downturn" in sales of the products.
March 1st, 2007
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Transforming FDA LogoAccording to Janet Trunzo, executive vice president of regulatory affairs at AdvaMed, the end of negotiations for the next version of MDUFMA is near. Speaking at the annual meeting of the American Institute for Medical and Biological Engineering this morning, Trunzo told attendees to expect a press release about the proposal within days. The negotiations involving the user fee system have been between AdvaMed, FDA, and key members of Congress. MDUFMA must be reauthorized by the end of September, and there's been a lot of closed door discussion about how it should be restructured, along with whether any of the other provisions should be changed. Stay tuned for more information...
February 28th, 2007
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Ex-FDA commissioner Lester Crawford was hit with a hefty fine of about $90,000 yesterday for lying about stocks he owned in FDA-regulated companies. He was also sentenced to three years supervised probation. The Associated Press reports that Magistrate Judge Deborah Robinson, who reportedly questioned Crawford's remorse, ordered him to conduct 50 hours of community service and to pick up the bill for the costs of his supervised probation.
February 28th, 2007
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