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CardioMEMS’ Heart Failure Monitor Foiled At Panel By FDA Inspection Findings Of Study Bias

This article was originally published in The Gray Sheet

Executive Summary

The firm’s PMA hopes are in question after recommendations made by company nurses to investigators in the CHAMPION trial, uncovered during FDA clinical-site inspections, dominated last week’s advisory panel meeting. The panel voted 6-4 that the benefits of the device do not outweigh its risks.

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