The FDA just cleared an Apple Watch band that measures your heart’s electrical activity

The AliveCor Kardia Band
Image: Alivecor

The Federal Drug Administration just cleared a new band for the Apple Watch that monitors the electrical rhythms in your heart. 

After a two-year process to satisfy the FDA’s stringent requirements, AliveCor announced today that the Kardia Band is now available for purchase for $199. It’s a mobile electrocardiogram (EKG), which measures a heart’s electrical activity and has traditionally been used by doctors to identify abnormal cardiac rhythms. 

“It’s a regulated measure of physiology by the FDA. Doctors can recognize over 100 conditions when they see an EKG,” AliveCor CEO Vic Gundotra told Mashable

But unlike conventional EKGs, this is one that you wear on your wrist. The heart rhythms display on the Apple Watch, and it takes about 30 seconds to collect the electrical signals. What’s more, the watch will notify the user when they might potentially be experiencing a common heart arrhythmia called Atrial fibrillation, or AFib. 

“It used to take a cardiologist, and you’d have to take off your shirt,” said Gundotra. “Now you can do it while at your kid’s soccer game. You can know in half a minute what’s going on in your heart.”

After being scrutinized by the FDA, Gundotra is confident the device accurately and reliably measures electrical heart activity.

“We had to prove that our algorithms are effective as a board of human cardiologists,” he said, noting that the stack of FDA regulatory papers “might be taller than me.”

We had to prove that our algorithms are effective as a board of human cardiologists

The Kardia Band can be especially useful for patients who suffer from AFib, Gordon Tomaselli, chief of the division of cardiology at John Hopkins University, told Mashable. “AFib may not be dangerous, however, it is associated with increased risk of blood clots in hearts,” he explained. “It also turns out to be a common cause of stroke that occurs for no obvious reason.”

“I think it’s a useful adjunct and useful for some patients,” he added. “And there are some people that want to know [they’re experiencing AFib] — and for those folks this is a great solution.”

Still, Tomaselli cautioned the Kardia Band might not be the best option for every single patient. 

“I think if you have a serious cardiac disease you should not be completely reliant on this to make a diagnosis,” said Tomaselli. “It is always best to make sure that your health care provider has a look at the rhythms.”

Most of all, he emphasized,If you don’t feel well, you need to see someone. Symptoms trump any recording.”

Besides watching for AFib, the Kardia Band is also infused with AI technology, a deep-learning tool the company calls “SmartRhythm Monitoring.” This program, however, doesn’t monitor heart rhythms. Instead, it watches your heart rate. The AI system checks your heart rate every five seconds, and will, based up your activity over the previous 30 minutes, notify you when your heart rate is pumping abnormally fast. 

For instance, the Kardia Band will alert you if your heart rate spikes, even though you might be idly sitting in a car.

“It worked on me when a cop pulled me over,” said AliveCor’s CEO, Gundotra. “We’re looking for things that don’t match our predictions.”

So for anyone that’s interested in better understanding their heart — both it’s rhythms and heart rate behavior — the Kardia Band can serve as a helpful tool. 

“It’s neat technology and there’s going to be more and more of this,” said Tomaselli. “I think some of this is going to be very useful not just in diagnosing things but helping, for those interested, to maintain their best cardiovascular health and fitness.”

And AliveCor’s Gundotra, after working through a tedious FDA approval process, feels the system validates this new technology. “We are very lucky to have such a strict regulatory body,” he said. “You can’t make ridiculous claims in this country.”

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Read more: http://mashable.com/2017/11/30/fda-clears-alivcor-kardia-band-for-apple-watch/