AliveCor receives approval for tracking hyperkalemia through ECG

The FDA gives the startup the thumbs-up to detect blood potassium levels
Wareable is reader-powered. If you click through using links on the site, we may earn an affiliate commission. Learn more

AliveCor has received approval from the Food and Drug Administration (FDA) to develop a non-invasive method of detecting high blood potassium levels.

The startup, which chiefly focuses on monitoring heart health, remains the only company to receive approval to monitor heart health through electrocardiograms (ECG) on the Apple Watch. And now, with its new "breakthrough device" designation from the FDA, it appears set to take on hyperkalemia, too.

Read this: Inside AliveCor's massive hyperkalemia study

Typically, the condition requires blood samples from sufferers, though AliveCor's method instead aims to use ECG measurements pick up on the high blood potassium levels. With these high levels linked to congestive heart failure, chronic kidney disease and diabetes, the technology could potentially be used to help millions of people monitor their health status.

"People die from too much potassium because too much potassium causes your heart to malfunction," AliveCor CEO Vic Gundotra told Wareable last year, when the company first teamed up with the Mayo Clinic to test its method.

"The electrical activity in your heart can go berserk, and that can lead to some very bad outcomes, including death."

But while we know the company's method, the form that the device applying the tech will take is unclear. Given the company's history of tracking ECG from the wrist, it isn't a big stretch to imagine a similar device to the company's KardiaBand (designed specifically for the Apple Watch) being used. However, given Apple is set to potentially announce built-in ECG monitoring for the Series 4, the exact form of AliveCor's hyperkalemia tracker could be subject to change.

Either way, AliveCor estimates that the technology will take another year to reach the market, as the company is still required to submit results from a clinical trial. However, the "breakthrough devices" tag from the FDA has helped speed this process up considerably.

Typically, this is saved for for products which offer "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 the FDA website.

We're looking forward to hearing more about the non-invasive method once the details become more fleshed out, but this represents a big milestone for both hyperkalemia sufferers and AliveCor.

AliveCor receives approval for tracking hyperkalemia through ECG

How we test

Conor Allison


Conor moved to Wareable Media Group in 2017, initially covering all the latest developments in smartwatches, fitness trackers, and VR. He made a name for himself writing about trying out translation earbuds on a first date and cycling with a wearable airbag, as well as covering the industry’s latest releases.

Following a stint as Reviews Editor at Pocket-lint, Conor returned to Wareable Media Group in 2022 as Editor-at-Large. Conor has become a wearables expert, and helps people get more from their wearable tech, via Wareable's considerable how-to-based guides. 

He has also contributed to British GQ, Wired, Metro, The Independent, and The Mirror. 

Related stories