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AngelMed Cardiac Monitor Panned At FDA Panel Over Clinical Trial Concerns

This article was originally published in The Gray Sheet

Executive Summary

An FDA advisory panel recommended against approval of the AngelMed Guardian System, an implant that watches electrical heart signals and sounds an alarm for early detection of ischemic events. The panelists couldn’t get past trial flaws, including failure to meet the primary endpoint and early cessation of patient enrollment.

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