AliveCor announced FDA clearance of the KardiaBand single-lead ECG device
for the Apple Watch. AliveCor are the pioneers in field of personal EKG
technology. It’s now easy to keep a watch on your heart simply by wearing this
device around your wrist. Pairing with the expertise and artificial intelligence
of Apple Watch, Kardiaband can detect sinus heart rhythm and atrial
fibrillation(Afib) discreetly in just 30 seconds by simply a touch of the
button.
KardiaBand is a self-contained, FDA-cleared, miniaturized ECG device.
The results
are displayed on the apple watch. The Kardia app pairs with SmartRhythm, a new
feature within the Kardia app, and receives continuous inputs about the heart
rate, rhythm and physical activity from Apple Watch's activity sensors. Using a FDA-cleared analysis algorithm, it
can sense if something is not normal and notifies the user to capture an EKG. The Kardia’s ECG analysis algorithm also
identifies if the ECG is normal or not. The captured EKG can be mailed to a healthcare provider.
The diagnostic
yield is at par to a 14-day ambulatory event monitor and Holter monitor.
Physicians
can use KardiaBand for arrhythmia assessment,
managing patients with AFib, diagnosing AFib early in high risk patients and patient
management of cardiac risk factors.
"KardiaBand
paired with SmartRhythm technology will be life-changing for people who are
serious about heart health," said Vic Gundotra, CEO, AliveCor.
"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
AFib, a leading cause of stroke, and other serious conditions."
AFib affects
nearly 30 million people round the globe, with 1 in 4 people more than 40 years
at risk of developing it. It is leading cause of stroke and 2 out of 3 strokes
are preventable if detected and managed on time.
Dr. Ronald
P. Karlsberg, MD FACC, Board Certified Cardiologist and Clinical Professor of
Medicine, Cedars Sinai Heart Institute and David Geffen School of
Medicine UCLA said, "This is a paradigm shift for cardiac care as well as
an important advance in healthcare."
"Today,
EKGs are available only in offices and hospitals, using complex equipment, and
usually only after a life-threatening event, for example a stroke. With an EKG
device on the wrist, AFib can be detected wherever the patient is, 24 hours a
day. In randomized research trials, KardiaMobile, the first AliveCor EKG
device, proved to be superior to routine care provided by physicians. Today,
KardiaBand is a giant leap in personalized health care," he added.
People all
around the world would be benefitted by AliveCor, because it provides peace of
mind by providing important diagnostic tool and communication between the
patient and cardiologist.
The device
runs on an internal lithium battery with a lifetime of 1-2 years, the sensor in
KardiaBand is always ready to use - with the recording screen open on your Apple
Watch, simply touch your index finger to the KardiaBand sensor to start a
recording.
If you do
not have Apple Watch, you can still use Kardia to record EKG on your mobile. The
basic service and Kardia app for mobile costs $99 as compared to KardiaBand
which costs $199.
News Release
All Media: AliveCor
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