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AccurKardia’s AK+ Guard gains FDA breakthrough device status
AccurKardia has gained the US Food and Drug Administration's (FDA) breakthrough device designation for its AI-powered ‘AK+ Guard’ software, aimed at identifying hyperkalaemia, a condition that can ...
Business Wire18d
AccurKardia Receives FDA Breakthrough Device Designation for AI-powered Hyperkalemia Detection Solution Using Lead I ECG Data
NEW YORK--(BUSINESS WIRE)--AccurKardia, an innovator in ECG-based diagnostics technology, has announced that it has received Breakthrough Device Designation by the U.S. Food and Drug ...