Wearable electrocardiogram monitor for Apple Watch cleared by FDA: Page 2 of 2

December 05, 2017 // By Rich Pell
Mobile heart solution developer AliveCor (Mountain View, CA) has announced FDA clearance of its KardiaBand wearable electrocardiogram (EKG) monitor in the U.S., allowing Apple Watch users to capture their EKG anytime.

Atrial fibrillation, which affects more than 30 million people worldwide, is the most common heart arrhythmia and a leading cause of stroke. One in four people over the age of 40 are at risk for developing it, and, says the company, millions of people around the world are unknowingly living with it.

"This is a paradigm shift for cardiac care as well as an important advance in healthcare," says 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. "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."

According to Karlsberg, randomized research trials have shown that AliveCor's KardiaMobile device has proven to be superior to routine care provided by physicians. Today, he says, KardiaBand represents "a giant leap in personalized health care."

KardiaBand is now available for $199 and requires a subscription to AliveCor's Premium service for $99 a year. The combined system includes SmartRhythm notifications on Apple Watch, unlimited EKG recordings, automatic detection of atrial fibrillation or normal sinus rhythm, the ability to send EKG readings via email, unlimited cloud history and reporting of all EKGs, weight and medication tracking, and a mailed monthly paper report on readings taken each calendar month.

AliveCor