Revolutionizing Kidney Care: AccurKardia’s AK+ Guard Earns FDA Breakthrough Device Designation
The software could offer a convenient way to extend hyperkalemia monitoring to the home for vulnerable patients.
AccurKardia has received breakthrough device designation by FDA for its ECG-based, AI-powered AK+ Guard hyperkalemia detection software. The investigational technology uses lead I ECG data to alert patients and clinicians of moderate to severe episodes of hyperkalemia (excess potassium in the blood) that can lead to sudden cardiac arrest.
