FDA Encourages Tech Industry, Okays Medical Apps


In a statement, the U.S. Food and Drug Administration (FDA) announced continued efforts to work with digital companies to find new ways to improve health care and empower consumers to take more control of their health and make more informed medical decisions. Included in this statement is FDA approval for two medical apps for the Apple Watch.

The apps were designed by Apple to monitor heart health. One app creates an EKG (electrocardiogram) reading to detect heart rhythm disorders like atrial fibrillation (afib), and the other analyzes a user’s pulse rate to identify abnormal heart rhythms and then notifies the user. The FDA worked closely with Apple as they developed and tested the mobile apps. The information they provide could identify health problems more quickly and allow users to seek important medical sooner.

According to results of a study published in JAMA Cardiology in May 2018, smartwatch technology detected atrial fibrillation in 51 participants seeking medical attention for an abnormal heart rhythm with high accuracy and correctly classified afib in 1,617 people who self-reported having the condition with moderate accuracy. This study was conducted by researchers from the University of California, San Francisco.

Sourced from: FDA and JAMA Cardiology