AliveCor KardiaBand Found to Detect AFib, Hyperkalemia
AliveCor is doing its best to transform the Apple Watch into a full-fledged medical device. After receiving FDA approval in November of last year for EKG (electrocardiogram) readings taken with KardiaBand, a replacement wristband for the Apple Watch, the company announced two studies that validated the device’s performance for medical purposes. The first study found that the EKG device was able to accurately detect atrial fibrillation, a type of irregular heartbeat that can lead to complications including stroke, blood clots, and heart failure. The second and more surprising study found that the device was also able to detect cases of hyperkalemia, a condition that occurs when a patient’s potassium levels are dangerously high, often as a result of kidney failure. AliveCor CEO Vic Gundotra spoke to MobiHealthNews on the revolutionary nature of the findings:
“As our team continues to push the bounds on innovation in digital health, we are on a path to changing the way AFib and hyperkalemia can be detected, and to defining the ways in which products like Apple Watch can play a role in the future of health care,” Vic Gundotra, CEO of AliveCor, said in a statement.
The Cleveland Clinic study, which has been accepted for publication in the Journal of the American College of Cardiology, found that the KardiaBand successfully detected atrial fibrillation and normal sinus rhythm with an accuracy level that was comparable to physicians interpreting the same ECGs, according to a statement. In fact, researchers found that the Kardia algorithm correctly interpreted atrial fibrillation vs normal sinus rhythm with 93 percent sensitivity and 84 percent specificity.
AliveCor is not the only company working to create add-on solutions to measure heart health with the Apple Watch.
In May Cardiogram, a startup working on algorithms to make the Apple Watch’s heart rate data clinically actionable, announced results from its mRhythm Study, which showed the company’s algorithms can detect atrial fibrillation with 97 percent accuracy. At the time researches said they would continue to hone the Cardiogram algorithm and explore the potential of using a deep neural network to detect other conditions.
In addition, Apple itself has been working to develop more health capabilities for the device. Indeed, it has been widely rumored that the company is even working on developing its own EKG reader for the watch.
Apple has become increasingly involved in atrial fibrillation detecting technologies. Notably In November the tech giant announced the Apple Heart Study, an Apple Watch-based ResearchKit study that uses the heart rate sensor to look at potential arrhythmias. The study, which is opened to anyone in the US who has an Apple Watch Series 1 or later and is over 21, continuously monitors participants heart rates. If the Apple Watch detects possible atrial fibrillation, the user will get a notification on their Apple Watch or iPhone, which will prompt them to connect with a doctor via telemedicine.
The second study found that EKG readings taken with the device, combined with a sophisticated AI analysis, was able to detect hyperkalemia with an accuracy rate of between 90 and 94 percent.
“The Mayo Clinic partnered with AliveCor…on trying to do something extraordinary, which was to to look at the ECG use artificial intelligence and hope the AI would be able to look at a single ECG and be able to tell you your potassium level,” Gundotra told MobiHealthNews. “That is kind of crazy because [calculate] potassium levels you usually have a blood test. High potassium or low potassium can be life threatening.”
Although the technology could revolutionize hyperkalemia testing, the results should be taken with a grain of salt until the company receives regulatory clearance for the system.
AliveCor claims that up until the KardiaBand was developed, the only way to test for hyperkalemia was through blood testing.
“This is totally new,” Gundotra said. “Two years ago people would have thought this was science fiction and until we get FDA clearance it’s not real. But I think the first step is publishing your results and this is a major milestone.”…
“This is medicine, this is people’s lives. There is a thoughtful process, you publish your data and have to work with trust partners and work with the FDA,” Gundotra told MobiHealthNews. “AliveCor trusts the process. Sometimes takes a little longer than we would like but you are dealing with human lives and so we appreciate why it takes that long.”