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Articles from 2008 In August

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Masimo Settles Patent Disputes with Two Rivals

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.

New Radiotherapy Technology Cleared

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.

New Company Uses Human Factors to Design Better Injector

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 EpiCard out, pulls off a safety tab, and holds an end of the product against any part of his or her body for five seconds. During that time, the needle comes out, injects the epinephrine, and retracts back into the device. The voice on the device then tells the user that the injection is complete, and tells them to get to a hospital. By contrast, the EpiPen needle remains exposed after the injection, and users have to be careful when putting the injector back in its case. Intelliject plans to file a New Drug Application with FDA in 2009. An NDA is required because the product's primary mode of action is as a drug.

Makers of Unproven Medical Device Sentenced

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.

Labeling-Change Rule May Protect Device Makers from Lawsuits

The biggest change is that a "Changes Being Effected" supplement -- known as a "Special PMA" supplement in the device world -- is now required "only if there is sufficient evidence of a causal association with the drug, biologic, or medical device." FDA says that during premarket reviews, it goes to great lengths to ensure that warnings and other components of labeling are based on sufficient scientific information. Therefore, it says, labeling changes should be held to the same standard. Of course the plaintiffs' lawyers don't like that. Scientific information sometimes gets in the way of their arguments.

Medicare's Claims of Progress Against Fraud Were Overstated

(An official version is expected to be released next week.) The discrepancy apparently comes from instructions CMS gave to its auditor, AdvanceMed Corp. CMS allegedly told AdvanceMed to only review the documents submitted by vendors, and not to verify them against physicians' records. Hence, AdvanceMed reported that 7.5% of claims were not supported by appropriate documentation, but the real figure is closer to 31.5%. Congress is angry, as it should be. "This agency is incompetent," said Rep. Pete Stark (D-CA). Indeed, it looks that way.

Medtronic, Nuvasive in Patent Battle

Coating Ventilator Tubes Reduces Pneumonia

Silver is widely used as an antimicrobial agent and has been shown to reduce bacterial pneumonia infections in animals. So Bard wanted to see if a silver coating would help reduce the infections in humans. The study tested the coated tubes between 2002 and 2006 on 1500 patients expected to be placed on a ventilator for more than 24 hours. When all was said and done, 4.8% of those with silver-coated tubes developed ventilator-associated pneumonia, compared with 7.5% of patients who were on ventilators with uncoated tubes. The coating also appears to have delayed the onset of pneumonia in the patients who did contract it. There was no impact on death rates, however. Kudos to Bard for stepping up to the plate to enable these findings to come to light. Ventilator makers should start using coatings on their tubes, if they haven't already.

Endeavor Boosts Medtronic's Profits