FDA Clears KardiaBand Apple Watch Heart Monitoring App

Device monitors heart rate and activity to detect and alarm symptoms.

California based medical device company AliveCor announced the FDA has cleared its new Apple watch EKG technology KardiaBandTM which integrates the popular consumer fitness monitor into a system that monitors and captures EKG data, so patients can detect common cardiac abnormalities like atrial fibrillation (AFib).

According to AliveCor, their device is the first FDA-cleared medical accessory for the Apple Watch. KardiaBand, it explained, is capable of recording an EKG in 30 seconds “with just a touch of its integrated sensor.”

AliveCor also announced the introduction of SmartRythm, a new feature that adds to the device’s capabilities. When SmartRythm is activated it uses artificial intelligence to evaluate the correlation between heart activity and physical activity. AliveCor explained that when SmartRythm detects that heart rate and activity are out of synch the device signals a user to capture an EKG using the company’s mobile EKG reader or the new KardiaBand.

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 noted: "This is a paradigm shift for cardiac care as well as an important advance in healthcare.” Geffen further explained that EKGs are typically only available in offices and hospitals, and involve using complex equipment, “usually only after a life-threatening event, for example, a stroke.”

With an EKG device on the wrist, Karlsberg said, “AFib can be detected wherever the patient is, 24 hours a day.” In randomized research trials, explained the physician, “KardiaMobile … proved to be superior to routine care provided by physicians … [and represents] a giant leap in personalized health care."

AFib, a leading cause of stroke affects more than 30 million people worldwide, with one in four people over 40 at risk for developing the condition. Vic Gundotra, CEO, AliveCor noted, "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.”

KardiaBand paired with SmartRhythm, he explained, can help people more easily check their heart health, “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."


Nigel Walker

Mr. Walker is the founder and managing director of That’s Nice LLC, a research-driven marketing agency with 20 years dedicated to life sciences. Nigel harnesses the strategic capabilities of Nice Insight, the research arm of That’s Nice, to help companies communicate science-based visions to grow their businesses. Mr. Walker earned a bachelor’s degree in graphic design with honors from London College of Communication, University of the Arts London, England.