The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to AccurKardia’s AK+ Guard, an innovative AI-driven software designed to detect hyperkalemia using Lead I ECG data. This technology enables early detection of potentially life-threatening potassium imbalances in high-risk populations, facilitating timely interventions outside clinical settings. Additionally, the company’s AK-AVS software for aortic valve stenosis screening has also received Breakthrough Device Designation, highlighting AccurKardia's commitment to transforming ECG into a versatile diagnostic tool.

Pioneering Non-Invasive Hyperkalemia Monitoring

AccurKardia’s AK+ Guard leverages advanced AI algorithms to analyze Lead I ECG data from various wearable devices, offering real-time alerts for moderate to severe hyperkalemia episodes. This breakthrough allows patients with chronic kidney disease (CKD) and other at-risk individuals to monitor their condition conveniently at home, reducing the need for frequent hospital visits. The integration of this technology into everyday wearables such as smartwatches marks a significant advancement in patient care.

Hyperkalemia, characterized by elevated blood potassium levels, can lead to sudden cardiac arrest if left undetected. Traditional diagnosis methods rely on blood tests, which are often inconvenient and time-consuming. AK+ Guard provides a non-invasive alternative that can be seamlessly integrated into daily routines. By detecting hyperkalemia early, this technology aims to reduce mortality rates associated with this condition, particularly among dialysis patients who face a 33% increase in all-cause mortality following a hyperkalemia episode. The convenience of continuous monitoring at home offers a promising solution for managing this asymptomatic yet dangerous condition.

Accelerating Regulatory Approval and Commercialization

AccurKardia’s AK+ Guard has been selected for the FDA Total Product Life Cycle Advisory Program (TAP), one of only 62 devices chosen for this prestigious initiative. TAP facilitates closer collaboration with the FDA, expediting the regulatory process while ensuring high standards of quality and safety. This program aims to enhance the efficiency of device evaluations, ultimately leading to faster commercial availability.

The inclusion in TAP underscores the potential impact of AK+ Guard on patient outcomes. According to Dr. Wei Ling Lau, Interim Chief of Nephrology at the University of California, Irvine, this technology could revolutionize the early detection of hyperkalemia, a condition that currently requires invasive blood tests for diagnosis. With approximately 37 million Americans affected by CKD, and over half a million on dialysis, the healthcare cost burden is substantial. Annual healthcare expenses for CKD patients with hyperkalemia reach $25,156, with hospital stays costing an average of $29,181. AccurKardia’s CEO, Juan C. Jimenez, emphasizes the company’s mission to improve patient care through innovative diagnostics, positioning AK+ Guard as a game changer in the management of this critical health issue.