FDA Gives Nod to Apple Watch EKG Reader Accessory

The U.S. Food and Drug Administration has given the KardiaBand its stamp of approval, AliveCor announced Thursday. The
device is the first FDA-cleared personal electrocardiogram (EKG) accessory designed for use with an Apple Watch.

The KardiaBand allows users to take EKG readings in order to distinguish between normal sinus heart rhythms and atrial fibrillation (A-fib), the most common type of serious heart arrhythmia, which can lead to strokes or other heart-related problems.

The KardiaBand can record an EKG in just 30 seconds. The user simply touches an integrated sensor, and the results are then displayed on the face of the Apple Watch.

AliveCor also announced the release of SmartRhythm, a new feature in the Kardia app. It
relies on artificial intelligence to monitor a user’s heart rate
and determine the correlation between heart activity and physical
activity. It can detect when a user’s heart rate and activity are out
of sync and promptly send an alert.

“KardiaBand paired with SmartRhythm technology will be life-changing
for people who are serious about heart health,” said Vic Gundotra, CEO
of AliveCor. Gundotra previously helmed Google+.

“These capabilities will allow people to easily and discreetly check
their heart rhythms when they may be abnormal, capturing essential
information to help doctors identify the issue and inform a clear path
of care to help manage A-fib, a leading cause of stroke, and other
serious conditions,” he added.

KardiaBand, which is now available for US$199, works in conjunction with AliveCor’s Premium
$99 a year subscription service. The combined system provides
subscribers with SmartRhythm notifications on Apple Watch, unlimited
EKG recordings, and automatic detection of A-fib or normal sinus rhythms.

Users can email unlimited EKG readings to anyone, including a
doctor, and are provided with unlimited cloud access to all EKG readings, along with weight and medication tracking. All of
this data is mailed to users in a monthly paper report with full
readings from the device.

Heart of the Matter

Although AliveCor’s KardiaBand is the first EKG device available for
the Apple Watch, it is just a small part of Apple’s fitness-monitoring efforts.

The company recently announced its Apple Heart Study app, the first research
study to utilize Apple Watch’s heart rate sensor to collect data on
A-fib. Apple partnered with Stanford Medicine to perform that research.

Smartwatches could become increasingly useful to help monitor heart-related
medical issues.

“There are millions of people with frequent or infrequent heart
arrhythmia who could benefit from a band like KardiaBand,” said Roger
Entner, principal analyst at Recon Analytics.

“It would help diagnosis and speed up treatment in cases where and
when it occurs, and it would certainly be a driver for people who have
heart arrhythmia, which is often a side effect of diabetes and other
heart disease,” he told TechNewsWorld.

Health and Technology

One issue might be how easy, convenient and even comfortable such a
device would be to wear, especially for extended periods. Further, some
users might rely on these devices as replacements for regular
doctor’s visits.

“It’s fine to instrument a person, as it enables closer monitoring,”
suggested Roger Kay, principal analyst at Endpoint Technology

“In general, early warning gives more information and is mostly not too
invasive, but of course people still need to be treated by healthcare
professionals,” he told TechNewsWorld.

“The app can’t do anything but tell you what’s going on at a detailed
level, so it makes sense for people at risk,” Kay noted. Still, “the device and app are a diagnostic tool to make it easier to treat,
not a replacement for treatment,” Recon Analytics’ Entner added. “Only
a doctor can do that.”

Widening the Market

As health costs continue to rise, smartwatch monitoring
devices could offer some financial benefits. Users might not feel the need to rush to the
emergency room every time they felt slightly off.

It’s possible that health and fitness monitoring devices will continue to become more highly specialized.

“This is the old ‘Swiss Army Knife’ versus dedicated function
wearables debate,” explained Robin Raskin, founder of Living in Digital Times.

“From my point of view, smartwatches won’t really take off until they
have some super useful functionality in the workplace, like payments or
physical access to buildings and computers,” she told TechNewsWorld.

“That said, AliveCor builds great products — and this one, I’m sure,
works well,” added Raskin.

More widespread acceptance may come via a mobile phone attachment, however, so it is unlikely that KardiaBand will broaden the smartwatch market, suggested Raskin.

“I don’t think too many people would buy and wear a device like the
KardiaBand without the need,” added Entner.

On the other hand, “I do think that if you own a watch and suspect you have
heart issues or just want info,” said Raskin, “this is a fabulous product.”

Peter Suciu has been an ECT News Network reporter since 2012. His areas of focus include cybersecurity, mobile phones, displays, streaming media, pay TV and autonomous vehicles. He has written and edited for numerous publications and websites, including Newsweek, Wired and FoxNews.com.
Email Peter.

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