FDA Clears an Apple Watch Feature That Helps Monitor AFib

Apple just made it easier to monitor atrial fibrillation (AFib), an irregular heart rhythm that increases the risk of stroke, with an Apple Watch feature.

The Food and Drug Administration (FDA) cleared the “AFib History” feature in the upcoming watchOS 9 update, allowing it to be used by users aged 22 and above who have been diagnosed with AFib. The new feature can estimate how frequently the wearer was in AFib and produce a weekly report that can be shared with a healthcare provider.

The watchOS 9 update is set to be released in the fall of 2022. It builds on the Apple Watch’s existing electrocardiogram (ECG) app, which has allowed wearers to capture heart data equivalent to a single-lead ECG by using their index fingers.

“While there is still research work to be done to best understand how to use these devices to monitor AF, the data to date has been helpful in showing us that the devices can detect AF in both symptomatic and asymptomatic individuals,” said Robert Harrington, MD, an interventional cardiologist and the chairman of the department of medicine at Stanford University.

Why Monitoring AFib Digitally Helps

AFib is the most common form of cardiac arrhythmia (irregular heartbeat) that affects at least 2.7 million Americans. If left untreated, it can lead to blood clots, stroke, and heart failure.

Wearable devices that monitor AFib can improve prevention and early diagnosis since many cases of AFib are asymptomatic. Some patients won’t be aware of their condition until a physical examination or they experience a cardiac event such as a blood clot or stroke.

A study conducted by a team from the Stanford University School of Medicine and funded by Apple reported that 34% of Apple Watch wearers who received an irregular pulse notification were identified as having AFib on a subsequent ECG patch reading.

Apple isn’t the only company developing effective heart monitoring apps and algorithms. FitBit sponsored a study in 2020 testing out a new software algorithm and found that it correctly identified AFib 98% of the time.

What’s Next for Digital Therapeutics

Many tech and pharmaceutical companies are partnering up to bring digital therapeutics to smartphones and wearables, which may help users manage chronic health conditions like heart disease, atopic dermatitis, and diabetes.

For example, Pfizer and digital care company Sidekick Health recently created a partnership to market an interactive digital therapeutic solution to improve patient adherence to treatment of atopic dermatitis.

Harrington explained that more research is needed to confirm technical feasibility and prove that the monitoring device brings an added value and benefit to the current standard of treatment.

“I do welcome this potential change in how we remotely monitor a number of chronic diseases including heart rhythm abnormalities and high blood pressure,” he said. “As long as a series of studies are done to prove feasibility and improved patient outcomes, I would recommend a digital therapeutic to my patients. In the meantime, I would certainly support that my patients consider participation in clinical studies that are focused on this type of work.”