AliveCor this week announced results from two studies of its Apple (NSDQ:AAPL) smartphone-connected KardiaBand personal electrocardiogram device, touting the bands ability to detect atrial fibrillation and its ability to detect high potassium levels.
Results from the studies, which were presented this week at the American College of Cardiology’s 67th Annual Scientific Session, provide more support to the usefulness and validity of the band as a cardiovascular health monitor, AliveCor CEO Vic Gundotra told MassDevice.com in an interview.
“Doctors will read healthcare news, but until once it’s been peer reviewed in a study, that’s when you start to see the tide turn,” Gundotra said. “We’re humbled by the cardiology community’s acceptance of AliveCor and we’re humbled that our latest innovation with the Apple Watch has gotten this kind of response.”
The first study, performed at the Cleveland Clinic and accepted for publication by the Journal of the American College of Cardiology, aimed to examine whether the KardiaBand could differentiate between atrial fibrillation and normal heart rhythm at a level similar to standard-of-care 12-lead EKGs, the Mountain View, Calif.-based company said.
“It is the first time the Apple Watch has ever been in a peer reviewed, published journal, a prestigious journal,” Gundotra said. “Cleveland Clinic compared the Kardia band with the Apple Watch, our combined solution, against a standard 12-lead EKG, which is what all doctors use hospital settings.”
Results from the study indicated that the KardiaBand was able to detect AF and normal sinus rhythm with comparable rates to those interpreted by physicians, and was able to correctly interpret AF versus normal sinus rhythm with a 93% sensitivity and 84% specificity. When physicians reviewed the KardiaBand recordings, sensitivity raised to 99%.
“We couldn’t be more thrilled with the outcome,” Gundotra said.
In the second study, researchers looked to explore whether the band, paired with a new artificial intelligence technology, could non-invasively detect high potassium levels – a condition known as hyperkalemia.
“Hyperkalemia kills people. It is a condition where an individual has too much potassium, and when potassium levels get too high, cells cannot conduct electricity correctly. As you can obviously imagine, the cells that are the most important to you that are unable to conduct electricity reside in your heart, and the moment you get hyperkalemic, your heart goes into a dangerous arrhythmia,” Gundotra said. “Today the only way to test for hyperkalemia is a blood test.”
The research, performed in collaboration with the Mayo clinic, examined over data points from more than 2 million EKGs alongside 4 million serum potassium values collected between 1994 and 2017 alongside prospective data from the AliveCor EKG device to develop an AI algorithm to detect hyperkalemia.
Results indicated that the AI platform was able to detect hyperkalemia with an accuracy ranging between 90% and 94%.
Gundotra is hopeful that future generations of the KardiaBand will feature the ability to detect hyperkalemia, alongside other applications aiming to improve cardiovascular health monitoring.
“The idea is that one day, you will simply be able to touch the Kardia band on an Apple Watch and know that you’re getting into a dangerous hyperkalemic state and get treated. The lives we could save would be amazing,” Gundotra said. “This is kind of the dream of artificial intelligence.”
Last November, AliveCor won FDA clearance for its KardiaBand device, with indications for monitoring for early signs of atrial fibrillation.
Initially introduced in March 2016, the KardiaBand is the first medical device accessory to be cleared by the federal safety watchdog for the Apple Watch. It’s designed to display and record clinical-grade cardiac rhythm readings in real time in about 30 seconds, the company said.