AliveCor gets FDA breakthrough status for bloodless hyperkalemia test


AliveCor, a Silicon Valley start-up that develops technology to monitor people’s heart health, on Monday received “breakthrough device” designation from the U.S. Food and Drug Administration for developing a new way to detect high blood potassium levels without requiring any blood.

AliveCor worked with doctors at the Mayo Clinic, which is also an investor in the company, to develop a new technology that looks for a dangerous condition called hyperkalemia without requiring any blood from the patient. It instead looks for patterns in electrocardiograms (ECGs or EKGs), which are essentially recordings of the electrical signals of the heart.

“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,” said Vic Gundotra, CEO of AliveCor, who previously worked on AI-related technology as a senior vice president of engineering at Google. “It’s a big milestone for us.”

Hyperkalemia is often caused by problems with the kidneys, like chronic kidney disease, which is suffered by some 30 million Americans, as well as type 1 diabetes and a slew of other medical conditions. It can be life-threatening for these patients, with symptoms including trouble breathing and irregular heartbeats.

The FDA’s “breakthrough devices” program was designed to speed up approvals for technologies and devices in rare cases. Regulators will consider cases where the product offers “more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases, for which no approved or cleared treatment exists or that offer significant advantages over existing approved or cleared alternatives,” according to its website.

The start-up currently sells an attachment to a smartphone to measure the heart’s rhythm, as well as a band that fits on Apple Watch. These devices sell for $99 and up.

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