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 suddenly cause cardiac arrests.
The software leverages ‘Lead I ECG’ data to provide timely alerts for this life-threatening condition that occurs due to high potassium levels in the blood.
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Compatible with a variety of FDA-cleared consumer and clinical devices such as smartwatches, AK+ Guard facilitates continuous monitoring of hyperkalaemia in subjects, especially those with chronic kidney disease (CKD) or end-stage renal disease, allowing for early intervention outside clinical settings, the company noted.
The recent FDA Total Product Life Cycle Advisory Program (TAP) inclusion of AK+ Guard is set to expedite the regulatory process, ensuring quality device evaluations and quicker market access.
AccurKardia’s portfolio also includes the AK-AVS software, which screens for aortic valve stenosis (AVS) by analysing ECG data. This software is aimed at identifying patients who may require echocardiograms for a definitive diagnosis.
Last October, the company gained breakthrough designation from the FDA for AVS ECG-based AI screening software.
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By GlobalDataAccurKardia CEO and co-founder Juan Jimenez said: “The two FDA actions supporting AK+ Guard mark another major milestone in AccurKardia’s journey towards achieving our mission to improve patient outcomes and save lives by transforming ECG into a broad biomarker.
“We believe the current standard of care for hyperkalaemia detection and monitoring is underserving patients, and we aim to deliver a speedier and more accessible pathway to detection and risk management that will make a meaningful impact on patient care.”
In the US, CKD affects an estimated 37 million individuals. A common complication of the illness is hyperkalaemia, which the company noted has been linked to a 16.6% increase in death rates.
