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.