AccurKardia, a company specializing in ECG-based diagnostics, announced that its AK+ Guard software has been granted Breakthrough Device Designation by the FDA. This AI-powered technology is designed to detect hyperkalemia using Lead I ECG data obtained from wearable devices, potentially preventing cardiac arrest through timely alerts to patients and clinicians.
AK+ Guard is designed for integration with a range of FDA-cleared consumer and clinical wearables that capture Lead I ECG data, such as smartwatches. This allows for hyperkalemia monitoring outside of traditional clinical settings, enabling earlier intervention for high-risk individuals, including those with end-stage renal disease and chronic kidney disease (CKD).
Clinical Significance
Hyperkalemia, characterized by elevated potassium levels in the blood, is often asymptomatic but can lead to life-threatening cardiac events. Current diagnostic methods rely on blood draws to measure potassium levels directly, which can be inconvenient and delay detection. AccurKardia's AK+ Guard offers a non-invasive, continuous monitoring solution that could significantly improve patient outcomes.
Wei Ling Lau, MD, Interim Chief of the Division of Nephrology, Hypertension & Kidney Transplantation at the University of California, Irvine, stated, "AccuKardia’s AK+ Guard has the potential to be a game changer in the early detection of moderate to severe episodes of hyperkalemia... The company’s novel solution could offer a convenient way to extend hyperkalemia monitoring to the home for vulnerable patients."
Market and Disease Burden
In the U.S., 37 million people suffer from CKD, and in 2024, 518,970 patients were on dialysis. Hyperkalemia is associated with a 16.6% increase in all-cause mortality among CKD patients. The risk is even higher in dialysis patients, where the mortality rate increases by 33% following a moderate to severe hyperkalemia episode. As many as 17% of dialysis patients experience these episodes annually.
The economic burden of hyperkalemia is also substantial. For CKD patients, the one-year healthcare cost associated with hyperkalemia is $25,156. The average hospital stay cost for a patient with hyperkalemia, published most recently in 2014, was $29,181, with an average hospital length of stay of 3.3 days.
Regulatory Pathway
In addition to the Breakthrough Device Designation, AK+ Guard has been accepted into the FDA's Total Product Life Cycle Advisory Program (TAP). This program provides AccurKardia with increased engagement with the FDA, potentially accelerating the regulatory process and improving the timeliness of device evaluations.
Juan C. Jimenez, co-founder and CEO of AccurKardia, commented, "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 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."
