AliveCor gets FDA breakthrough status for Hyperkalemia diagnosis

September 13, 2018  Source: drugdu 207


Hyperkalemia is defined as the condition where there would be a higher potassium level in blood. The potassium level goes higher due to chronic kidney disease and type 1 diabetes, suffered by millions of people. Irregular heartbeat is the common symptom of hyperkalemia. A blood sample is required to detect the potassium level till date.

But a Silicon Valley start-up company named AliveCor along with the doctors from Mayo Clinic have developed a novel technology, where the blood sample is not required. Just by looking at the electrocardiogram (ECG) pattern which records the electric signals of the heart, the level of potassium can be detected.

Hence, the U.S. Food and Drug Administration had given ‘breakthrough device’ designation on 10th September 2018 for a novel way of potassium level measurement.

Vic Gundotra, the CEO of AliveCor, said "It was a pie-in-the-sky idea that we could use AI to see something like this in the ECG when no one else could; It's a big milestone for us."

This screening tool would prove beneficial for the patients who stay at home and don’t prefer to visit labs and give the blood sample.

AliveCor team expects that this product would reach the market in a year, after the submission of clinical trial results.

By editor