The U.S. Food and Drug Administration has granted AliveCor the designation of “breakthrough device” for its ability to detect a rare but dangerous blood condition called hyperkalemia without taking any blood from the patient.
Hyperkalemia is a medical term describing elevated potassium levels in the blood and is usually found in those with kidney disease. The correct amount of potassium is critical for the function of nerve and muscles in the body, including your heart muscle. A blood potassium level higher than 6.0 mmol/L can be dangerous and usually requires immediate treatment, according to the Mayo Clinic.
A surprising 31 million people in the U.S. suffer from chronic kidney conditions leading to potentially elevated levels of potassium. Nearly 500,000 of those with the condition are on dialysis as their kidneys are no longer able to function.
AliveCor is able to detect elevated levels of potassium in the blood using the company’s specifically trained deep neural network and data from its electrocardiograms (ECG) technology, similar to those captured by AliveCor’s KardiaMobile and KardiaBand devices.
The new designation means the FDA will begin to fast-track the technology, enabling patients with kidney disease to use AliveCor for home-based detection of elevated potassium levels.
AliveCor was cleared late last year by the FDA to use its KardiaBand technology as a medical device for the Apple Watch to detect abnormal hearth rhythm. Allowing kidney and heart patients to use this technology at home would potentially save lives by detecting and warning them that something is wrong before heading into the doctor’s office to get checked.
“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,” AliveCor CEO Vic Gundotra said in a statement. “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.”