AliveCor gets FDA breakthrough status for bloodless hyperkalemia test

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AliveCor, a Silicon Valley start-up that develops expertise to observe folks’s coronary heart well being, on Monday acquired “breakthrough system” designation from the U.S. Meals and Drug Administration for growing a brand new method to detect excessive blood potassium ranges with out requiring any blood.

AliveCor labored with medical doctors on the Mayo Clinic, which can be an investor within the firm, to develop a brand new expertise that appears for a harmful situation known as hyperkalemia with out requiring any blood from the affected person. It as a substitute seems to be for patterns in electrocardiograms (ECGs or EKGs), that are basically recordings of the electrical indicators of the center.

“It was a pie-in-the-sky concept that we may use AI to see one thing like this within the ECG when nobody else may,” mentioned Vic Gundotra, CEO of AliveCor, who beforehand labored on AI-related expertise as a senior vice chairman of engineering at Google. “It is a massive milestone for us.”

Hyperkalemia is usually attributable to issues with the kidneys, like power kidney illness, which is suffered by some 30 million Individuals, in addition to sort 1 diabetes and a slew of different medical circumstances. It may be life-threatening for these sufferers, with signs together with bother respiration and irregular heartbeats.

The FDA’s “breakthrough units” program was designed to hurry up approvals for applied sciences and units in uncommon instances. Regulators will think about instances the place the product gives “simpler therapy or prognosis for life-threatening or irreversibly debilitating illnesses, for which no authorized or cleared therapy exists or that provide important benefits over current authorized or cleared alternate options,” in response to its web site.

The beginning-up presently sells an attachment to a smartphone to measure the center’s rhythm, in addition to a band that matches on Apple Watch. These units promote for $99 and up.

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