First FDA clearance for medical device accessory for smartwatchDec. 4, 2017 - news
KardiaBand has received FDA clearance in the U.S., allowing Apple Watch users to capture their electrocardiogram (EKG) anytime, anywhere in order to quickly detect normal sinus heart rhythms and atrial fibrillation (AF). This first FDA-cleared medical device accessory for the smartwatch can record an EKG in 30 seconds with just a touch of its integrated sensor. Results from the Kardia App are displayed on the smartwatch.
SmartRhythm is a new feature within the Kardia app. SmartRhythm uses artificial intelligence in concert with inputs from Apple Watch’s heart rate and activity sensors to continuously evaluate 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 EKG with KardiaBand, or with KardiaMobile, a portable EKG reader.
“This is a paradigm shift for cardiac care as well as an important advance in healthcare,” said 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, AF 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”