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Home » Newsletters » BioWorld MedTech

BioWorld MedTech

Dec. 12, 2011

View Archived Issues

FDA advisory committee: Champion PMA falls over trial violations, real-world use issues

GAITHERSBURG, Maryland Protocol violations are not unheard of in pivotal device trials, but the trial for the CardioMEMS (Atlanta) Champion heart monitoring system was badly violated by FDA's reckoning thanks to communication from the sponsor to study sites. However, the FDA circulatory systems advisory committee voted that the risk-benefit dynamic was not supported for the diagnostic as much because of concerns that real-world use of the device would not match the way the Champion diagnostic was utilized in the pivotal trial, rendering a 6-4 vote that the risk-benefit profile did not measure up. Read More

Edwards looking forward to 'transformational' 2012

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International report : Mindray to acquire controlling stake in Greenlander HIT company

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Medtronic's AdaptivStim trial boasts positive results

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Financings roundup: Hansen Medical secures $30M loan to help with cash position

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MDD's Fun Facts

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Deals roundup: Span-America acquires assets of M.C. Healthcare Products

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HIT roundup: Mobile Aspects releases iRIS Touch for supply automation

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Med-Tech Notes: IRS says Boston Sci owes $581M in back taxes

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Agreements/contracts: Clarient, Acorn Research in pact for molecular testing of tumors

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Med-Tech Notes: Snoring Center to open Newport Beach office

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Product Briefs

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Med-Tech Notes: Invacare in discussions with FDA

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MDD's Neurology Extra

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