The AngelMed Guardian System is a cardiac monitoring system designed for use in patients who have suffered acute coronary syndrome events before, to detect quick ST elevation changes potentially linked to coronary ischemia.
The system consists of an implantable device, an external component, and a programmer.
The AngelMed Guardian System's PMA application is being reviewed at the same March meeting of the Circulatory System Devices panel as Abbott's Absorb GT1. As with that product, timing is difficult to forecast, but there is potential for the system to receive FDA approval this year.
These products do not have U.S. FDA regulatory clearance or approval as of January 22, 2016.
[Image courtesy of ANGEL MEDICAL SYSTEMS, INC.]
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