The Food and Drug Administration (FDA) has given its approval to AliveCor to detect high blood potassium (hyperkalemia) levels using a non-invasive method. This startup is the only company to receive approval to use electrocardiograms (ECG) for monitoring heart health. It has now got approval for monitoring blood potassium levels. Generally, potassium levels are detected using blood samples. However, this non-invasive technology uses ECG measurements to detect high blood potassium levels, which are linked to chronic kidney disease, diabetes, and congestive heart failure.
Early detection of blood potassium levels can help prevent many diseases. When AliveCor first teamed with the Mayo Clinic last year to test the device, the CEO, Vic Gundotra told Wareable, “People die from too much potassium because too much potassium causes your heart to malfunction. The electrical activity in your heart can go berserk, and that can lead to some very bad outcomes, including death.” While we understand the method, we are still not sure the form that the tech will take. Seeing the company’s history of tracking ECG from the wrist, we think that it will probably create a device that is similar to the KardiaBand that was specially designed for Apple smartwatch. Now that we are expecting Apple to announce the built-in ECG monitoring in Apple series 4 smartwatch, we don’t know how this new device is to be designed. AliveCor estimates that it would take another year for this technology to make it to the market as it is still waiting for results from the clinical trials.
The “breakthrough devices” tag from FDA could possibly speed up the process. According to FDA website, this term is reserved for products that “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,” We are waiting to hear more about this non-invasive method. It is sure to be a huge milestone for the startup and hyperkalemia sufferers.