FDA grants breakthrough designation to AliveCor’s KardiaK hyperkalemia software

AliveCor said this week it won breakthrough device designation from the FDA for its KardiaK software platform intended to screen for hyperkalemia, or elevated levels of blood potassium, without the need for drawing blood.

The Mountain View, Calif.-based company said the KardiaK system uses a proprietary deep neural network intended to detect hyperkalemia using data from electrocardiograms similar to those captured through its KardiaMobile and KardiaBand ECG devices.

AliveCor said it hopes the platform will allow users with kidney disease and other life-threatening conditions to check for hyperkalemia at home and prevent deaths related to the condition.

“We are gratified that the artificial intelligence work we’re doing at AliveCor has been deemed so meaningful that it has achieved FDA Breakthrough Device status. We view it as a key milestone in our corporate history and look forward to the further development of our non-invasive Hyperkalemia detection tools,” CEO Vic Gundotra said in a press release.

“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. It may save people’s lives, and save the health care system dollars,” Dr. Paul Friedman of the Mayo Clinic team that co-developed the test said in a prepared statement.

In March, AliveCor announced results from two studies of its Apple (NSDQ:AAPL) smartphone-connected KardiaBand personal electrocardiogram device, touting the bands ability to detect atrial fibrillation and its ability to detect high potassium levels.

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