Cardinal Health, a wholesaler of drugs and other medical products, has agreed to buy a firm that specializes in infection control for $490 million, Reuters reports. Enturia Inc. is best known for ChloraPrep, an antiseptic formulation that is applied to a patient with an applicator before surgery. Its products fit in with other Cardinal properties geared toward infection prevention, such as surgical apparel.
March 4th, 2008
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FDA has reversed itself over patient-recruitment and statistical-analysis issues for Vasogen Inc.'s Celacade System, a combination product that treats heart inflammation. Responsibility for lead review has been switched from CDRH to CBER (though the product will remain regulated as a medical device). CDRH had asked the company to use a Bayesian study design, but it now says the approach is not justified because of concerns about how patients in the product's two main studies were recruited. The company says it will respond to the agency soon. Vasogen was named one of MD...
March 3rd, 2008
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Times haven't been easy for Baxter International. Yesterday the company agreed to pay a $15,000 fine for improperly testing irradiation equipment at its facility in Puerto Rico. The Associated Press is reporting that a March 2007 inspection revealed Baxter didn't conduct regular safety tests of irradiators that are used to kill germs on medical products. They also failed to keep accurate and complete records of the safety inspections and maintenance tests, according to inspectors, who attributed the problems to "deliberate acts" committed by Baxter employees. The same facility was fined $44,000 in 2004 for violations that included not following safety protocols intended to protect employees from radiation exposure. Baxter has been under the spotlight recently for its blood thinner heparin that has resulted in several deaths. The company...
February 29th, 2008
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An official for the Department of Health and Human Services told Congress yesterday that existing laws are not strong enough to prevent device companies from making inappropriate payments to doctors. Gregory Demske, assistant inspector general for HHS, told the Senate Special Subcommittee on Aging that "the anti-kickback statute itself is insufficient to address the influence of money in this industry because of the high burden of proof," Reuters reports. The statute requires the government to prove willful conduct, which makes it difficult to win cases, he explained. A bipartisan proposed bill would require device and drug firms to report all payments to doctors via an annual report that would be made public online. Not every payment is inherently sketchy, as device companies must rely on physician feedback during the device-development process. But it will help boost public...
February 28th, 2008
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The Senate Special Committee on Aging is holding a hearing today on medical device companies' payments to doctors, in light of disclosure that five orthopedics companies made $221 million in such payments in 2007. (These are the same firms that settled antikickback charges last year; the disclosure is part of the settlement.) The committee is asking questions about retaining physicians as consultants. Its chairman, Herb Kohl (D-WI), is proposing a bill that would mandate disclosure of consulting payments by device and drug companies with $100 million or more in annual revenues. AdvaMed has come out in favor of the bill, provided that it is amended to "protect legitimate payments to surgeons." Medtronic, too,...
February 27th, 2008
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Former U.S. Attorney General John Ashcroft is under fire from Congress over his consulting firm's arrangement to monitor Zimmer Holdings as part of the orthopedics firm's settlement with the government over kickback charges. The Washington Post reports that Ashcroft has agreed to testify before a House subcommittee on the monitoring arrangement, which could net his firm between $28 million and $52 million over 18 months. Congressional Democrats and some scholars are concerned whether such high fees are justified, and whether corporate monitorships are in danger of becoming tools for political patronage. Zimmer agreed to the monitoring in exchange for the government holding off on an indictment. It and four other orthopedics firms were accused of paying kickbacks to doctors as an incentive to use their products. Zimmer paid the largest fine of...
February 26th, 2008
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ConforMIS announced that it has launched a unicompartmental knee resurfacing implant and related disposable instrumentation. It represents another step toward "personalized medicine." The iUni is one of the firm's four patient-specific implants designed for those with osteoarthritis of the knee. It is geared for patients who have damage in the medial or lateral compartments of the knee, but not in other parts. Each implant is designed from a patient's CT scan and is made specifically for that patient. The company says that because each implant is custom-designed, it allows for true resurfacing of the femur and complete coverage of each weight-bearing surface.
February 25th, 2008
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A patient suing the current marketer of the ProDisc after it came apart in his back is now also suing two companies involved in its development, read more >>
February 22nd, 2008
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Some Congressional Democrats read more >>
February 21st, 2008
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Medtronic has won read more >>
February 20th, 2008
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