Revolutionizing Kidney Care: AccurKardia’s AK+ Guard Earns FDA Breakthrough Device DesignationRevolutionizing Kidney Care: AccurKardia’s AK+ Guard Earns FDA Breakthrough Device Designation

AccurKardia has received breakthrough device designation by FDA for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software. The investigational technology uses lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia (excess potassium in the blood) that can lead to sudden cardiac arrest.

AK+ Guard is designed to work with a wide range of FDA-cleared consumer and clinical wearables that currently capture lead I ECG data, such as smartwatches, enabling hyperkalemia monitoring outside of the clinic and earlier intervention for high-risk populations. These include those with end-stage renal disease (ESRD), chronic kidney disease (CKD), and other risk factors.

AK+ Guard was also recently accepted as one of 62 devices in FDA’s total product lifecycle advisory program (TAP). The TAP program provides earlier and more frequent engagement with FDA, helping accelerate the regulatory process, improve the quality and timeliness of device evaluations, and ultimately speed commercialization.

“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,” said Juan C. Jimenez, co-founder and CEO of AccurKardia. “We believe the current standard of care for hyperkalemia 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.”

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Jimenez told MD+DI most consumer smartwatches are capable of recording lead 1 ECG signals.

“Therefore, what we envision, once we complete our clinical validation and we launch this product to market, is that our software will be available to be used with clinical grade ECG but also with consumer grade FDA-cleared devices such as the Apple Watch, Samsung Watch, Fitbit, et cetera,” Jimenez said.

Patients with end-stage renal disease typically go to dialysis three times a week. But, Jimenez said, sometimes in the period between dialysis treatments, their potassium levels may not be optimal, and there could be events of hyperkalemia in those patients, increasing their mortality risk as well as increasing the likelihood that they need to be treated in the emergency department and/or admitted to a hospital.

Graphic courtesy of AccurKardia via Business Wire

AccurKardia’s technology is designed to help patients monitor themselves for hyperkalemia episodes, giving them and their clinicians a notification that they may be having a hyperkalemia event in between the dialysis treatment. Jimenez likened the technology to a continuous glucose monitoring technology, but for CKD and ESRD populations.

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“AccuKardia’s AK+ Guard has the potential to be a game changer in the early detection of moderate to severe episodes of hyperkalemia, a life-threatening yet often asymptomatic condition that currently can only be diagnosed via blood draw to directly measure potassium levels,” said Wei Ling Lau, MD, interim chief of the division of nephrology, hypertension, and kidney transplantation at the University of California, Irvine. “The company’s novel solution could offer a convenient way to extend hyperkalemia monitoring to the home for vulnerable patients.”

The AK+ Guard news follows AccurKardia’s recently received breakthrough device designation for its Aortic Valve Stenosis (AVS) screening software, AK-AVS, which is designed to leverage the ubiquity of the electrocardiogram (ECG) to identify potential cases of aortic valve stenosis within millions of ECGs already present in healthcare system electronic health records. AK-AVS software aims to help identify and prioritize which patients should receive echocardiograms for a definitive diagnosis.

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