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FDA clears medical device accessory for Apple Watch

Steve Rogerson
December 5, 2017

The US FDA has cleared the first medical device accessory for the Apple Watch. AliveCor's KardiaBand allows users to take a 30 second ECG right on the wrist.
The KardiaBand pairs with SmartRhythm in the Kardia Watch app to evaluate heart rate and physical activity intelligently, and instantly push notifications to take an electrocardiogram (ECG).
California-based AliveCor says this means Apple Watch users can discreetly capture their ECG anytime, anywhere to detect quickly normal sinus heart rhythms and atrial fibrillation (AFib), the most common heart arrhythmia.
KardiaBand can record an ECG in 30 seconds with a touch of its integrated sensor. Results from the Kardia App are displayed on the face of Apple Watch.
SmartRhythm is a new feature within the Kardia app for Apple Watch. It uses artificial intelligence in concert with inputs from Apple Watch's heart rate and activity sensors to evaluate continuously the correlation between heart activity and physical activity. When SmartRhythm detects that heart rate and activity are out of sync, the device notifies users to capture an ECG with KardiaBand, or with KardiaMobile, AliveCor's portable ECG reader.
"KardiaBand paired with SmartRhythm technology will be life changing for people who are serious about heart health," said Vic Gundotra, CEO of 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 is the most common heart arrhythmia, and a leading cause 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 AFib. Yet, two out of three strokes are preventable when AFib is detected and treated appropriately.
"This is a paradigm shift for cardiac care as well as an important advance in healthcare," said Ronald Karlsberg, certified cardiologist and clinical professor of medicine at Cedars Sinai Heart Institute and David Geffen School of Medicine UCLA. "Today, ECGs are available only in offices and hospitals, using complex equipment, and usually only after a life threatening event, for example a stroke. With an ECG device on the wrist, AFib can be detected wherever the patient is, 24 hours a day. In randomised research trials, KardiaMobile, the first AliveCor ECG device, proved to be superior to routine care provided by physicians. Today, KardiaBand is a giant leap in personalised health care."
AliveCor uses artificial intelligence, mobile, cloud and micro-electrode technology to change the dynamic in cardiac care. It empowers people worldwide to manage heart health proactively and to improve the quality of care in the fight against heart disease. KardiaMobile and KardiaBand enable people and their care teams to detect and manage possible abnormal heart rhythms.
KardiaBand is available for $199 and requires subscription to AliveCor's Premium service for $99 a year. The combined system includes: SmartRhythm notifications on Apple Watch; unlimited ECG recordings; automatic detection of AFib or normal sinus rhythm; the unlimited ability to send ECG readings to anyone via email; unlimited cloud history and reporting of all ECGs ever taken; weight and medication tracking; and a mailed monthly paper report on readings taken each month.
Apple is also working with researchers at Stamford University to use the Apple watch to collect heart rhythm data that could be used to notify users who have AFib.