AccurKardia has begun a multi-center clinical pilot study of AK+ Guard, its artificial intelligence (AI)-powered technology that detects hyperkalemia using Lead I ECG. The three-arm prospective pilot study will evaluate more than 150 patients across U.S. inpatient, outpatient, and home settings.

“The goal of this pilot is to get an early demonstration of performance in the intended use population and reproduce the results from our retrospective validations in real-world settings,” AccurKardia Chief Product Officer Moin Hussaini stated.

Hyperkalemia—an excess of serum potassium in the blood—is a common condition affecting patients with chronic kidney disease (CKD), end stage renal disease, and heart failure that can lead to dangerous arrhythmias and sudden cardiac arrest. It triggers 1 million to 2 million U.S. hospitalizations, 10,000 deaths, and $2 billion annually in core hospitalization-related economic burden, according to AccurKardia.

The firm’s AK+ Guard software received U.S. Food and Drug Administration (FDA) Breakthrough Device Designation and is compatible with a wide range of FDA-cleared consumer and clinical wearables (e.g., smartwatches). The software is designed to improve patient outcomes and reduce the burden of hyperkalemia on the healthcare system through remote monitoring.

“Bringing accurate hyperkalemia detection to common consumer and clinical grade wearables for the remote monitoring of hyperkalemia in vulnerable CKD and heart failure populations would be a game-changer,” said Dr. Wei Ling Lau, chief of the Division of Nephrology at the University of California at Irvine. “If I saw a concerning result in a monitored patient, I could intervene immediately with a potassium-binding medication.”

In a 20,750 patient retrospective clinical validation study performed with data from Mayo Clinic, AK+ Guard achieved 89% accuracy for detecting moderate-to-severe hyperkalemia—which is on par with many gold standard diagnostics and remote patient monitoring solutions.

“I frequently treat patients admitted for hyperkalemia. It would be a huge benefit to patients and the healthcare system if we had an accurate way to detect and intervene before hyperkalemia results in a costly hospitalization,” said Dr. Omar Darwish, associate professor of the Hospitalist Program at the University of California at Irvine.

AccurKardia was selected as a quarterfinalist earlier this year in the Digital Health Hub Foundation 2025 Digital Health Awards, Best in Class: AI in Patient Care featuring AK+ Guard.

AccurKardia is an ECG-led diagnostics software company aiming to transform ECG data into a more powerful diagnostic tool and broad biomarker to improve patient outcomes. With initial applications in cardiology, the company offers cloud-based diagnostic tools, including AccurECG, an FDA-cleared class II software as a medical device (SaMD) for fully automated, near real-time ECG interpretation. AccurKardia’s aortic stenosis detection model, AK-AVS, received FDA Breakthrough Device Designation in October 2024. Its AK+ Guard hyperkalemia detection software received FDA Breakthrough Device Designation and was accepted in the FDA Total Product Life Cycle Advisory Program (TAP) in early 2025. The company completed the 2024 Cohort of MedTech Innovator (MTI) and was one of five companies selected for the American Heart Association’s Heart and Brain Health Accelerator track within MTI.