AliveCor gets a green light from FDA to screen for dangerously high potassium levels in the blood
The U.S. Meals and Drug Administration has granted AliveCor the designation of “breakthrough machine” for its capacity to detect a uncommon however harmful blood situation known as hyperkalemia with out taking any blood from the affected person.

Hyperkalemia is a medical time period describing elevated potassium ranges within the blood and is normally present in these with kidney illness. The correct quantity of potassium is essential for the operate of nerve and muscle mass within the physique, together with your coronary heart muscle. A blood potassium stage larger than 6.zero mmol/L might be harmful and normally requires immediate treatment, in accordance with the Mayo Clinic.

A shocking 31 million people within the U.S. undergo from persistent kidney circumstances resulting in doubtlessly elevated ranges of potassium. Practically 500,000 of these with the situation are on dialysis as their kidneys are now not capable of operate.

AliveCor is ready to detect elevated ranges of potassium within the blood utilizing the corporate’s particularly educated deep neural community and information from its electrocardiograms (ECG) know-how, just like these captured by AliveCor’s KardiaMobile and KardiaBand units.

The brand new designation means the FDA will start to fast-track the know-how, enabling sufferers with kidney illness to make use of AliveCor for home-based detection of elevated potassium ranges.

AliveCor was cleared late final 12 months by the FDA to make use of its KardiaBand know-how as a medical machine for the Apple Watch to detect irregular fireside rhythm. Permitting kidney and coronary heart sufferers to make use of this know-how at house would doubtlessly save lives by detecting and warning them that one thing is improper earlier than heading into the physician’s workplace to get checked.

“We’re gratified that the factitious intelligence work we’re doing at AliveCor has been deemed so significant that it has achieved FDA ‘Breakthrough Gadget’ standing,” AliveCor CEO Vic Gundotra mentioned in an announcement. “We view it as a key milestone in our company historical past and look ahead to the additional improvement of our non-invasive Hyperkalemia detection instruments.”

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