AK+ Guard for Hyperkalemia Detection

AccurKardia recently announced that it received Breakthrough Device Designation from the FDA for its AK+ Guard hyperkalemia detection software. AK+ Guard is also one of just 62 devices accepted into the FDA Total Product Life Cycle Advisory Program. Both FDA initiatives could help hasten the regulatory process and time to commercialization for the new software.

AK+ Guard is artificial intelligence–powered software that uses lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia that can lead to sudden cardiac arrest. The software is designed to work with consumer and clinical wearables that capture lead I ECG data, such as smartwatches and Fitbits. This would allow for monitoring hyperkalemia outside the clinic and earlier intervention among at-risk patients, including those with chronic kidney disease or end-stage renal disease and those receiving dialysis or medications for hyperkalemia or any others that could cause hyperkalemia.

Wei Ling Lau, MD, of the University of California, Irvine spoke with Nephrology Times about the potential effect of the new technology on hyperkalemia management.