By Allison Proffitt
November 30, 2017 | AliveCor today announced Food and Drug Administration clearance of KardiaBand in the U.S., a band for the Apple Watch with an embedded electrocardiogram (EKG or ECG) device. KardiaBand lets users capture a medical EKG and quickly identify abnormal heart rhythms such as atrial fibrillation (AF). The FDA clearance covers the EKG device embedded within the KardiaBand; and the algorithms that report normal sinus rhythm, atrial fibrillation, or an unknown rhythm.
KardiaBand is on sale today for $199, and is the first FDA-cleared medical device accessory for the Apple Watch. It fits both sizes of Apple Watch and looks similar to Apple’s sports band, but with a silver sensor on the band and a true buckle closure. The sensor itself is newly-designed, barely bigger than a nickel, Vic Gundotra, CEO of AliveCor, told Diagnostics World. Users put one thumb on the sensor on the outside of the watch band, pressing a second sensor inside the watch band against their wrist. The two sensors record an EKG in 30 seconds, and results are transmitted to the Apple Watch via ultrasonic high frequency sound.
Results are displayed on the watch face and in the companion Kardia phone app: either a normal heart rhythm, atrial fibrillation, or an unknown rhythm. The process works like AliveCor’s earlier KardiaMobile device, which can be carried separately or attached to the back of a cell phone. KardiaMobile sells for $99.
AliveCor announced a KardiaBand in March 2016, but at that point did not have FDA clearance. At the time, the company said it expected to receive 510K clearance within a few months, but the device was never granted clearance. Since then the band has only been for sale in the UK, Germany, Hong Kong, Ireland, and Switzerland.
“That device we announced a year ago bears almost no resemblance to what we’re launching [today],” Gundotra told Diagnostics World. You might want to consider that version 1. What we’re announcing… is version 2.”
AI For AFib
Most interesting, though, is a new feature within the Kardia app. SmartRhythm is an artificial intelligence platform that uses data from Apple Watch’s heart rate and activity sensors to evaluate the correlation between heart activity and physical activity. When the two don’t align, the app prompts users to take an immediate EKG.
“We built a deep neural network—basically artificial intelligence using an autoregressive neural network—it’s a trained, unsupervised neural network where we trained it on normal people—healthy people—and people that had arrhythmias,” Gundotra explained. “We asked the artificial intelligence to make a prediction based on your heart rate right now: What should your heart rate look like in the next minute?”
When those two numbers don’t align, something might be wrong.
The Kardia app alerts users to take an EKG. In some cases, there’s a reasonable explanation for a sudden change in heart rhythm—Gundotra relates a spike he saw recently when he was pulled over by a policeman. But in other cases, a sudden change is more worrisome.
In either situation, the SmartRhythm platform will improve as more data are added. The global model will be updated regularly, Gundotra said. And it will also always take into account what Gundotra calls “hinting”—data on your personal activity, time of day, and other variables that the Apple Watch already records.
“We’re going to, over time, train it to understand you better, to understand the global population better. The more people that use this watch, the smarter it gets,” Gundotra explained.
AliveCor worked closely with Apple to design the device and the app, Gundotra explained, and he thinks the KardiaBand will change the way doctors view data coming from the Apple Watch.
Heart rate monitors on Apple Watches and other fitness devices work using a green light photoplethysmography or PPG sensor that shines into the skin and measures how quickly blood is flowing to determine heart rate. Consumers may love closing rings based on activity and exercise, but “PPG sensors are broadly ignored by doctors,” Gundotra said. “They don’t care about your step count and your heart rate.”
He believes AliveCor’s SmartRhythm will “upgrade” the PPG sensor from a fitness feature to a health tool.
And Gundotra insists that the health implications will be vast. Atrial fibrillation, the most common heart arrhythmia, is one of the leading causes of stroke. It affects more than 30 million people worldwide, and one in four people over the age of 40 are at risk for developing it. Millions of people around the world are unknowingly living with this condition. It can take years to diagnose a patient with AF. KardiaBand along with SmartRhythm monitoring could shorten that window.
Data Deluge
KardiaMobile users already take about 20 EKGs a month, Gundotra said. And Kardia app users can set an alarm to prompt regular EKGs, for instance, take a resting heart rate every morning before you get out of bed. With SmartRhythm monitoring running continuously, there will likely be even more EKGs.
This presents a storage problem. AliveCor’s Premium service costs $99 a year and offers unlimited EKG recordings, storage, the option to email reports to anyone, and monthly summary reports mailed to the user in hard copy. “Once you turn on SmartRhythm monitoring and we’re getting data from your heart rate every five seconds and we’re going to store that for your whole life in HIPAA-compliant storage, that does cost something,” Gundotra said. The premium service has been optional for KardiaMobile, but will be required for KardiaBand.
KardiaBand is available for purchase today for $199 at
https://store.alivecor.com/.