Single-Lead AI ECG Tool Detects Moderate-to-Severe Hyperkalemia Outside Clinic

Hyperkalemia can escalate quickly and is commonly monitored through laboratory blood draws, leaving risk between clinic visits. Clinicians need timely, accessible tools to identify moderate to severe elevations before cardiac complications arise, particularly in patients with chronic kidney disease or heart failure. A new AI-enabled electrocardiogram (ECG) software system now offers noninvasive, out-of-clinic hyperkalemia detection using single-lead signals.

AccurKardia’s AK+ Guard has been named “Best New ECG Technology Solution” in the 10th annual MedTech Breakthrough Awards. The program recognizes innovative digital health and medical technology solutions worldwide and reported a record number of nominations from companies across more than 20 countries this year. The recognition spotlights a tool designed to support clinicians and patients in managing hyperkalemia outside traditional settings.

AK+ Guard is an AI-powered hyperkalemia detection software that analyzes Lead I ECG data to alert patients and clinicians to moderate to severe episodes. The system uses advanced deep learning trained on paired ECG and blood-serum values to transform a standard single-lead trace into a noninvasive metabolic biosensor, correlating subtle electrical signatures with elevated potassium. Designed to interface with consumer and clinical wearables, including smartwatches, it enables out-of-clinic monitoring that may prompt earlier intervention to prevent exacerbations or sudden cardiac events.

The model has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) and was accepted into the agency’s Total Product Life Cycle Advisory Program (TAP) in January 2025. At present, AK+ Guard is for research use only, has not been cleared or approved by the U.S. FDA, and is under development for investigational purposes. It is intended to support hyperkalemia risk assessment using Lead I ECG.

An independent validation study across the Sharp HealthCare system evaluated detection of moderate-to-severe hyperkalemia, defined as potassium ≥6.5 mmol/L, using Lead I ECG. In results presented at the 2025 American Heart Association Scientific Sessions, the model achieved an area under the receiver operating characteristic curve of 0.903. Sensitivity was 82.3% and specificity was 82.5%.

The MedTech Breakthrough program, now in its 10th year, spans categories from telehealth and patient engagement to medical devices and electronic health records. Organizers noted the growing global impact of digital healthcare, with submissions from more than 20 countries. The recognition does not constitute an endorsement by Tech Breakthrough LLC.

“We saw that the current standard of care for hyperkalemia detection and monitoring had been underserving patients. Our solution delivers a speedier, more accessible pathway to detection and risk management, making a meaningful impact on patient care. AK+ Guard detects hyperkalemia in the ECG when it begins to pose a cardiac risk, and enables monitoring between lab visits. We’re also proud that our AI delivers equitable, high-performance diagnostics across diverse populations, a critical differentiator in medical AI,” said Moin Hussaini, chief product officer of AccurKardia.

“AccurKardia’s AK+ Guard represents a fundamental leap forward in patient care. By replacing a blood draw with an AI-processed signal, AK+ Guard empowers patients to monitor themselves at home or anywhere, non-invasively and frequently. AccurKardia has not just automated a manual task; they are enabling a life-saving physiological measurement that was previously impossible to obtain outside of a laboratory,” stated Steve Johansson, managing director, MedTech Breakthrough.

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