What You Should Know:
– AccurKardia, a diagnostics technology innovator, has initiated a multicenter clinical pilot for its AK+ Guard technology.
– The AI-powered device, which has been designated as an FDA Breakthrough Device, can detect hyperkalemia—an excess of serum potassium in the blood—using a standard Lead I ECG.
AI-Powered Hyperkalemia Detection
Hyperkalemia is a serious condition that affects millions of people with chronic kidney disease (CKD) and heart failure and can lead to dangerous arrhythmias and sudden cardiac arrest. The condition results in 1 to 2 million hospitalizations annually in the U.S., 10,000 deaths, and a $2 billion economic burden from hospitalizations.
The AK+ Guard software is compatible with a wide range of FDA-cleared consumer and clinical wearables, such as smartwatches. This enables remote monitoring of hyperkalemia, which could significantly improve patient outcomes and reduce the burden on the healthcare system.
“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.
89% Accuracy in Detecting Moderate to Severe Hyperkalemia
In a retrospective clinical validation study of over 20,000 patients, AK+ Guard achieved an impressive 89% accuracy in detecting moderate-to-severe hyperkalemia, a result on par with many gold-standard diagnostic tools. Dr. Omar Darwish, Associate Professor of the Hospitalist Program at the University of California at Irvine, highlighted the potential of the technology to help detect and intervene before hyperkalemia leads to a costly hospitalization. The goal of the current prospective pilot study is to evaluate the technology’s performance in a real-world setting with more than 150 patients across different care environments
Moin Hussaini, chief product officer of AccurKardia, added, “The goal of this pilot is to get an early demonstration of performance in the intended use population and reproduce the impressive results from our retrospective validations in real-world settings.”
