AccurKardia has announced its recent acquisition of the FDA’s breakthrough device designation for its cutting-edge AI-based software designed to detect hyperkalemia using ECG data.
The AK+ Guard platform utilizes Lead I ECG readings to identify and alert both patients and healthcare providers about moderate to severe incidents of hyperkalemia. A condition marked by elevated potassium levels in the blood, hyperkalemia poses risks such as sudden cardiac arrest, as outlined in the announcement. Notably, alongside the breakthrough status, the FDA included this software in its Total Product Life Cycle Advisory Program (TAP).
AccurKardia developed AK+ Guard to integrate seamlessly with a variety of FDA-cleared consumer and medical wearable devices. These devices, which include smartwatches, already capture Lead I ECG information. Such integration paves the way for hyperkalemia monitoring beyond clinical settings, offering earlier intervention possibilities for individuals at high risk. This group encompasses those facing end-stage renal disease, chronic kidney disease (CKD), and other predisposing factors.
The FDA’s recognition of AK+ Guard as a breakthrough device follows closely on the heels of another similar acknowledgment for AccurKardia. The company recently received the designation for its ECG-based AI application aimed at aortic valve stenosis (AVS) screening in the month of October.
Juan C. Jimenez, AccurKardia’s co-founder and CEO, expressed pride in their progress: “These recent FDA endorsements of AK+ Guard represent key milestones on our path to fulfilling our mission of enhancing patient outcomes and saving lives through innovative ECG biomarker tools,” he stated. “Current hyperkalemia detection and management standards fall short, in our view, and we strive to provide a faster, more accessible means of identifying and managing risks, significantly impacting patient care.”