Newest Apple Watch carries FDA approval

Sep 14, 2018

Apple’s newest watch also offers a new medical device: one of the first over-the-counter electrocardiograms, or EKGs.

Apple's newest watch carries an FDA-approved electrocardiogram.
Credit Getty Images

Apple watches have had onboard heart-rate monitors since their introduction in 2014, but the fourth generation watch, due to be released Sept. 21, offers an FDA-approved ability to analyze heart rhythm, too.

Heart rhythm analysis allows the watch to detect signs of conditions including atrial fibrillation, which the Centers for Disease Control and prevention says affects millions of Americans.

Atrial fibrillation is an irregular heartbeat that often does not present any symptoms for years, said Sarah Taylor, a cardiologist at Rochester Regional Health.

“Oftentimes, the first symptom is a stroke,” Taylor said. “In fact, in patients who’ve had a stroke, about 30 to 40 percent of those were caused by atrial fibrillation,” even though it’s common for stroke victims to not know they had the condition.

Industry analysts and medical experts have called it a bold move on Apple’s part.

“Capturing meaningful data about someone’s heart in real time is changing the way we practice medicine,” Ivor Benjamin, president of the American Heart Association, said Wednesday at Apple’s event announcing the watch.

Taylor said she’s glad patients will have access to more information about their own hearts, and she’s not concerned about the medical profession losing out to technology companies.

“Rochester is so rich in its health care resources, but this tool is following in the latest trend in putting a lot of this power and knowledge into the patient’s hand directly,” Taylor said.