Alivecor gets a green light from FDA to screen for dangerously high potassium levels in the blood

Alivecor gets a green light from FDA to screen for dangerously high potassium levels in the blood

By Sarah Buhr

The U.S. Food and Drug Administration has granted AliveCor the designation of ‘breakthrough device’ for it’s 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 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 …read more

Source:: TechCrunch Gadgets

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