ImpediMed Ltd., which manufactures a medical device for the clinical assessment of secondary lymphedema of the arm in female breast cancer patients, has been named a finalist in the 2009 Innovation Shootout, taking place in January in Los Angeles and Silicon Valley. The Innovation Shootout is sponsored by the six state governments of Australia, each of which chooses a local company that has developed a cutting-edge technological advance as its state finalist. Finalists will give presentations about their companies on January 13th during the Innovation Fast Pitch. This round takes place at the Business Technology Center, which is run by the Community Development Commission of the County of Los Angeles. The companies will then travel to the Bay Area to participate in the Innovation Shootout on January 15th at the Quadras Conference Center in Menlo Park. The winner will be selected by a panel of judges including technology experts, members of the media, and venture capitalists....
December 12th, 2008
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Research in the December issue of the Journal of the American College of Surgeons suggests that hospitals with surgical procedures that are shorter in duration and use of fewer blood transfusions have a low incidence of surgical site infections (SSI). Researchers compared 20 low SSI incidence and 13 high SSI incidence hospitals with regard to patient characteristics, operative variables, structural variables, and processes of care. Results of the analysis showed that hospitals with high SSI rates performed operations that took significantly longer on average compared with hospitals with low SSI rates (128 +/- 104.3 min. compared with 102.7 +/- 89.9 min., respectively; p<0.001). In addition, hospitals with low SSI rates were less likely to administer transfusions than hospitals with high SSI rates (5.1% versus 9.7%, respectively; p = 0.03). In the article in the December issue...
December 9th, 2008
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According to federal jury, Medtronic infringed on an artificial disc patent held by Swiss-based Spine Solutions Inc. Synthes, the company that purchased Spine Solutions, is entitled to $5.8 million in lost profits and infringing sales reached $9.1 million, the jury concluded, and these two figures will be used to decide the final charges against Medtronic. The patent violation case involved Synthes' ProDisc II (aka ProDisc-L), for the lower region of the back, and Medtronic's Maverick, A-Mav, and O-Mav. The suit was filed last March in Memphis.
December 8th, 2008
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St. Jude Medical today announced that its neuromodulation division, formerly Advanced Neuromodulation Systems, has adopted the St. Jude Medical name. The St. Jude Medical Neuromodulation Division unveiled its new brand identity and showcased its flagship products at the 12th annual North American Neuromodulation Society (NANS) meeting, which began today in Las Vegas. St. Jude Medical acquired Advanced Neuromodulation Systems in 2005 and continued to develop, manufacture, and market implantable neuromodulation products under that name. A new corporate brand identity features the theme, “More Control. Less Risk.” The message reflects St. Jude Medical’s dedication to advancing the practice of medicine by focusing on reducing risk wherever possible and contributing to successful outcomes for every patient. The company is developing new technologies to address a growing list of neurological disorders. Clinical studies are currently under way for Parkinson’s disease, essential...
December 6th, 2008
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The Wall Street Journal reports that there is turmoil in discussions to replace FDA Commissioner Andrew von Eschenbach. Although von Eschenbach has not yet announced his plans, his departure is expected soon. In the meantime, Representative Bart Stupak (D-MI), has asked Obama to avoid naming a replacement, in particular anyone associated with current FDA leadership. In a letter Wednesday to Mr. Obama, Stupak wrote, "I would encourage you not to appoint any current senior FDA employee as Commissioner or Interim Commissioner of the FDA," reports the journal. He added, "Current senior FDA employees are too close with the industries they regulate, creating a question of who they are working for." He called for a "complete change in the FDA's leadership." The letter doesn't name any officials. Janet Woodcock's name has been in conversations as a possible interim or permanent FDA chief. Other nonFDA...
December 5th, 2008
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A little Fun Friday News: A company claims to have received federal approval to market a 9-mm handgun as a medical device and hopes the US government will reimburse seniors who buy the $300 firearm. The product is called the Palm Pistol. It is designed to ease firing for people who may suffer from arthritis and other debilitating conditions that may result in difficulty squeezing a trigger. Constitutional Arms informed a medical technology blog that FDA had approved the Palm Pistol as a medical device, classifying it as a "Daily Activity Assist Device." I couldn't find proof of the approval. The company only provided proof that it had submitted paperwork (pdf) to register its facility as a medical...
December 5th, 2008
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Exercising caution and taking fewer risks while remaining committed to innovation is likely to be a theme for 2009. The turbulent economy isn’t causing havoc on the medical device industry, but manufacturers are being advised to be more strategic with the decisions they make this year and possibly beyond. Companies that have most of their business rooted in medically necessary procedures or technologies aren’t seeing a large negative effect, but those more involved in elective procedures are starting to see some softness, according to Maslowski. As their concerns grow, many might become more conservative in the areas of investment and expansion. Manufacturers also aren’t necessarily taking fewer risks in investing in new technologies just because the market isn’t doing well. However, one hypothesis is that if the credit crunch continues, funding sources for smaller companies with newer technologies could dry up. However, while companies still need to keep an open mind about...
December 5th, 2008
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Medegen announced that it has won its case in the United States Court of Appeals for the Federal Circuit in Washington, DC. The appellate court's decision reverses a judgment issued by a district court judge in the Central District of California of patent noninfringement entered in favor of ICU Medical Inc. Medegen argued that the decision inappropriately narrowed the definition of key terms of one of its patents (U.S. Patent No. 5,730,418). The patent covers a number of Medegen’s needleless connectors, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications. The case is now returned to the lower court with the appellate court having interpreted key claim language as Medegen had requested.
December 2nd, 2008
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The strengthening of the U.S. dollar could spell trouble for exporters of medical devices. It's already showing in some of the strongest medical device firms. St. Jude Medical cut its fourth-quarter and fiscal 2009 outlook this week, reports CNNmoney.com. Its revenue boost from overseas sales because of a positive foreign-exchange rate is about to even out. Jeffries and Co. thinks the firm could still have trouble meeting its new guidance. Its analysts believe that SMJ is the weakest of all cardio companies because of its reliance on foreign currency boost. On a positive note, most analysts have likely already factored in the changing exchange rates. They seem optimistic about the company's ability to continue to see profits.
December 2nd, 2008
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Johnson & Johnson (New Brunswick, NJ) is acquiring breast implant manufacturer Mentor Corp. (Santa Barbara, CA). The company's products will be added to J&J's Ethicon surgical products unit, and the acquisition is anticipated to close in 2009's first quarter. It's interesting that J&J has decided to buy a company rooted in aesthetics during a time when people are limiting spending on nonessentials. However, the companies issued a joint statement, asserting that the deal provides J&J with the “opportunity to strengthen its presence in aesthetic and reconstructive medicine.”
December 1st, 2008
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