FDA Defends Apple Watch Heart-Monitoring Apps, As Physicians Raise Concerns

The U.S Food and Drug Administration (FDA) has moved in to quell concerns about two heart monitoring apps on the new Apple Watch Series 4, which physicians worry could lead to unnecessary paranoia.

One of the apps is capable of conducting an electrocardiogram (ECG), while the other analyzes pulse rates and is able to warn a user if they possibly have a serious heart condition called atrial fibrillation (AFib).

Top of the list of worries is that AFib is notoriously difficult to diagnose and that the apps could trigger anxieties in perfectly healthy people.

“There will no doubt be some individuals who suffer unneeded anxiety, and will probably experience unneeded physician visits because of what they will find,” argues Greg Marcus, a cardiologist and director of clinical research at the University of California San Francisco.

Another concern is that ECGs are considered to be a very sensitive procedure and its readings can be distorted by a patient’s anxiety or nervousness.

“There’s a good reason doctors recommend ECGs from an experienced professional. They are most reliable when done in a controlled environment and looked at by a trained professional,” Ashok Panjabi, a cardiologist at the Krishna Cardiac Care Centre in Mumbai, India, said.

However, the FDA has defended its decision to approve the two apps on latest Apple Watch, saying the health care sector has been slow in adopting disruptive technologies “momentum toward a universal digital future in health care is advancing.”

To keep up with the latest healthcare trends, the FDA said it worked closely with Apple, as the company developed and tested the apps, which they think will help millions of users identify health concerns more quickly.

The Apple Watch Series 4 has an electrode embedded in the back and on its crown. Users can obtain readings by placing a finger on the crown for half a minute. If the heartbeat is not normal, the watch will notify the user and point out that this can cause poor blood flow and increase the risk of other cardiovascular conditions such as heart attack and stroke.

The increased prevalence of chronic diseases and an aging population is fueling the need for the digital transformation of healthcare to enable patients to monitor their health and take care of themselves. When it comes to the future of medicine, Dr. Simon Stertzer, world renowned cardiologist and pioneer in interventional cardiology envisions most innovation to come from “a combination of both devices and biopharmaceuticals paving the way for the improvements in disease treatment.”

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