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CardioMEMS Has Better Luck With FDA Advisory Panel Second Time Around

FDA’s Circulatory System Devices panel wrestled with a new analysis of the CHAMPION trial of the Champion heart failure monitor Oct. 9. CardioMEMS was banking that the new analysis would eliminate the doubts about possible bias that undermined the company’s first effort to earn FDA approval in 2011.

An FDA advisory panel agreed that the benefits of CardioMEMS Inc.’s Champion implantable heart failure monitoring system outweigh its risks and that the system is safe, but a majority of panel members said they were not certain the device is effective at improving patient outcomes.

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