Bloodless Hyperkalemia Test Gets FDA's Breakthrough Device Designation

With the designation, the FDA will review the technology on an accelerated clearance track
With the designation, the FDA will review the technology on an accelerated clearance track

AliveCor announced that the Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the KardiaK Software Platform, a new bloodless test to screen for hyperkalemia

The KardiaK Platform works through a deep neural network trained to detect hyperkalemia based on data from electrocardiograms (ECG) similar to those captured by the Company's KardiaMobile and KardiaBand devices. The Company's algorithm to detect hyperkalemia was based on >2 million ECGs linked with 4 million serum potassium values collected between 1994 to 2017. The AI algorithm demonstrated an area under the receiver operating characteristic curve (AUC) of 0.88–0.89.

With the designation, the FDA will review the technology on an accelerated clearance track specific for medical devices that demonstrate the potential to address unmet needs for life-threatening or irreversibly debilitating diseases or conditions. 

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"This test, which performed extremely well in our evaluation using millions of ECGs, holds the promise of enabling people to painlessly determine whether a life-threatening and otherwise silent and very treatable condition is present – from the comfort of their own homes and within seconds," stated Paul Friedman, MD, Chair of the Department of Cardiovascular Medicine and a member of the Mayo Clinic team that co-developed the test.

For more information visit AliveCor.com.