AccurKardia announced today that it received FDA breakthrough device designation for its ECG-based, AI-powered hyperkalemia detection software.
The AK+ Guard software uses Lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia. These episodes of excess potassium in the blood can lead to sudden cardiac arrest, according to a news release. In addition to breakthrough designation, the FDA accepted the software into its Total Product Life Cycle Advisory Program (TAP).
AccurKardia designed AK+ Guard to work with a wide range of FDA-cleared consumer and clinical wearables. These wearables, such as smartwatches, currently capture Lead I ECG data. This combination could enable hyperkalemia monitoring outside of the clinic and earlier intervention for high-risk populations. That includes those with end stage renal disease, chronic kidney disease (CKD) and other risk factors.
Breakthrough device designation for AK+Guard follows another recent breakthrough nod for AccurKardia. The company picked up the designation for its aortic valve stenosis (AVS) ECG-based AI screening software in October.
“The two FDA actions supporting AK+ Guard mark another major milestone in AccurKardia’s journey towards achieving our mission to improve patient outcomes and save lives by transforming ECG into a broad biomarker,” said Juan C. Jimenez, co-founder and CEO of AccurKardia. “We believe the current standard of care for hyperkalemia detection and monitoring is underserving patients, and we aim to deliver a speedier and more accessible pathway to detection and risk management that will make a meaningful impact on patient care.”
