AliveCor’s KardiaBand scored twice in recent clinical studies. It’s uncommon for us to cover the same product twice in the same year, let alone the same calendar quarter. Here’s one of those exceptions that prove the rule. We wrote about the afib detecting Apple Watch accessory KardiaBand’s FDA clearance in January. Two months later the personal ECG device is back in the news with clinical validation of two functions. A Cleveland Clinic study reported successful atrial fibrillation detection when the band is used with an Apple Watch. A Mayo Clinic study demonstrated another KardiaBand capability: detecting potentially fatal high potassium levels (hyperkalemia) without drawing a blood sample for testing.
Cleveland Clinic researchers published their Kardiaband afib detection study results in the Journal of the American Collge of Cardiology. Physicians compared Kardiaband and standard ECG recordings of 100 patients. Of 113 interpretable readings, the KardiaBand algorithm accurately differentiated between atrial fibrillation and sinus rhythm. The study deemed the technology acceptable for use in cardioversion patient screening to avoid unnecessary procedures. The hyperkalemia detection study by Mayo Clinic researchers compared a Kardia single-lead ECG-calculated potassium levels with phlebotomy-based blood measurement results. The study of 21 chronic hemodialysis patients produced results capable of analysis with 18 subjects. Three patients had rapidly conducted atrial fibrillation averaging more than 100 beats a minute – the Kardia could not reliably detect ECG features from those patients. The results from the remaining 18 patents accurately calculated the serum potassium levels with a high degree of statistical significance.
FDA clearance for wearable tech devices is required for sale in the U.S., but clinical validation builds credibility and increases the likelihood that clinicians will use the devices. Because both high and low potassium blood levels are dangerous and asymptomatic, the KardiaBand’s clinically tested ability to measure potassium as well as afib increases the Apple Watch accessory’s significance. And from a broader perspective, this demonstrates how sufficiently accurate data from one biometric measure can provide actionable insight into a different health indicator.