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CardioMEMS Has Better Luck With FDA Advisory Panel Second Time Around

This article was originally published in The Gray Sheet

Executive Summary

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.

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