AccurKardia announced that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia ...
AccurKardia, an innovator in ECG-based diagnostics technology, has announced that it has received Breakthrough Device ...
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 ...
AccurKardia's AK+ Guard is designed to work with a wide range of FDA-cleared consumer and clinical wearables that currently capture Lead I ECG data (e.g., smartwatches), enabling hyperkalemia ...
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 ...
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AccurKardia’s AK+ Guard gains FDA breakthrough device statusAccurKardia has gained the US Food and Drug Administration's (FDA) breakthrough device designation for its AI-powered ‘AK+ ...
NEW YORK, January 07, 2025--(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 ...
AccurKardia has been granted FDA Breakthrough Device Designation for its AI-driven AK+ Guard hyperkalemia detection solution. The software leverages Lead I ECG data to notify patients and ...
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