ConvaTec, the wound care products maker recently spun off from drug giant Bristol-Myers Squibb, has acquired Unomedical, a Danish maker of single-use devices, reports NJBiz.com. Terms of the deal were not disclosed, but the combined firm, which will operate under the ConvaTec name, is expected to have annual sales of around $1.6 billion. The company will sell off Unomedical's wound-care division, at the insistence of European antitrust regulators. The firm will have four main divisions: ostomy care, wound therapeutics, continence and critical care, and infusion devices.
September 3rd, 2008
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Cardinal Health has sold off a unit of Viasys Healthcare just a little more than a year after acquiring that company, reports Triangle Business Journal of Raleigh-Durham-Chapel Hill, NC. The conglomerate, whose core business is drug and medical product distribution but which has bought several device companies in recent years, sold its Medsystems business to Linden LLC, a private equity firm, for an undisclosed sum. Medsystems, which will be renamed Corpak Medsystems Inc., makes enteral devices and airway management products. Cardinal said Medsystems did not fit into its future plans. Viasys, which Cardinal bought in June 2007 for $1.54 billion, was named as one of MD...
September 3rd, 2008
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Beginning in October, CMS will no longer pay for treatments of certain infections acquired by patients while they were in a hospital or other healthcare facility. (More about this topic appears in the September issue of MD...
September 3rd, 2008
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A federal court has reduced the amount Boston Scientific must pay Medtronic for patent violations from $250 million to $19 million, reports the Boston Globe. The U.S. District Court in Marshall, TX also invalidated two of the three Medtronic patents that Boston Scientific had been found to have violated. The patents concerned stent technology. A Texas jury had determined the $250 million award in May. Boston Scientific said it will appeal the $19 million award to the U.S. Court of Appeals for the Federal Circuit.
September 2nd, 2008
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Researchers from the University of Cincinnati and BlackHagen Design are conducting a survey on sustainability issues related to the medical device industry. Results will be presented at the IDSA national conference in late September. The survey asks about attitudes toward sustainability/environmental friendliness within current healthcare practices, and about any efforts that device companies are making to be more environmentally friendly without compromise of care. To take the survey, go here.
August 28th, 2008
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Masimo Corp., a leading manufacturer of pulse oximeters, has settled a patent lawsuit brought by two competitors without incurring liability, according to the Associated Press. Shaklee Corp. sued Masimo in July 2007, claiming that Masimo violated a patent for the calibration technology in Shaklee's pulse oximeters. Soon after, NIR Diagnostics Inc. also joined the suit. Both companies sought damages and injunctions. Masimo countersued. But now, Shaklee and NIR have dropped their claims with prejudice, and Masimo has dropped its claims without prejudice. DeviceTalk will return on Tuesday, September 2.
August 28th, 2008
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TomoTherapy Inc. said it has received 510(k) clearance for its TomoDirect radiation therapy technology, according to a release posted on devicelink.com. TomoDirect is a new discrete-angle, sliding-beam delivery mode for the firm's Hi·Art treatment system. The Hi·Art treatment system combines integrated CT imaging with conformal radiation therapy to deliver radiation treatments with fast and precisely, while reducing radiation exposure to surrounding healthy tissue. TomoDirect allows clinicians to choose which angle to use, and which modulation level to use.
August 27th, 2008
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The temporary treatment for those experiencing severe allergic reactions is to inject themselves with epinephrine. For 25 years, the preferred injector has been the EpiPen, made by DEY LP. But a pair of identical twins with severe food allergies decided they didn't like the EpiPen's design, and came up with their own. Eric and Evan Edwards invented the EpiCard and founded Intelliject. Even though the product's primary mode of action is as a drug, the Edwards brothers considered their idea a medical device, and used human factors principles when designing it. They sought out a number of caregivers and patients for their opinions on what they liked and disliked about the EpiPen and about the Edwards' designs. The end result is a product that is smaller, simpler to use, and hides the needle except for the five seconds during injection. It has voice commands that tell the user exactly what to do during the process. The user takes the...
August 26th, 2008
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A Washington state couple who used an unproven medical device to treat people with hepatitis and cancer have been sentenced for fraud, reports the Seattle Times. Donald and Sharon Brandt offered treatments at their clinic with what they called a "vibe machine." They claimed it used radio frequencies to cure diseases. But they never sought FDA approval for the device, and at least one person they attempted to treat died. The charges arose from an investigation by FDA and the Washington State Department of Health. The Brandts had earned almost $808,000 in treatment fees since 1995. Donald Brandt, who sometimes posed as a doctor despite not having a medical license, was sentenced to 30 days in prison and four months of home detention. Sharon Brandt was sentenced to five months of home detention.
August 25th, 2008
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FDA has issued a new rule on labeling changes made to a PMA device, drug, or biologic. Plaintiffs' lawyers say the changes will read more >>
August 22nd, 2008
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