AngelMed Cardiac Monitor Panned At FDA Panel Over Clinical Trial Concerns
This article was originally published in The Gray Sheet
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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A US FDA advisory panel unanimously voted down the AngelMed cardiac monitor two years ago. But venture-backed Angel Medical Systems was able to engage with the agency after the panel, and the firm ultimately achieved approval of the device designed to help detect heart attacks earlier. It’s a lesson in firms leveraging all the data they have at their disposal.
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