AccurKardia Earns FDA Breakthrough Device Designation for AK+ Guard™
AccurKardia, a pioneer in ECG-based diagnostics technology, has announced a major milestone: the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its AK+ Guard™ hyperkalemia detection software. This investigational technology leverages Lead I ECG data to detect moderate to severe hyperkalemia (excess potassium in the blood) and alert patients and clinicians, potentially preventing life-threatening cardiac events. AK+ Guard™ is designed to integrate with a variety of FDA-cleared consumer and clinical wearables, such as smartwatches, that already capture Lead I ECG data. This innovation enables hyperkalemia monitoring outside of clinical settings, offering earlier detection and intervention opportunities for high-risk populations. The device is particularly beneficial for patients with chronic kidney disease (CKD), end-stage renal disease, and other risk factors.
