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Victory From The Jaws Of Defeat: Angel Med Wrests Approval For Implantable Heart-Attack Monitor

 
• By David Filmore

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.

Two years ago, a US FDA advisory panel delivered a strong rebuke to Angel Medical Systems Inc.'s implantable AngelMed Guardian System for detecting heart attacks early. But now the firm has finally gained US approval for the device after working out a new clinical analysis plan with the agency.

FDA approved Angel's PMA on April 9 for the implantable cardiac monitor that is about the size of a pacemaker, according to the agency's PMA database. The device performs an...

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