Apple Watch: FDA-cleared for electrocardiogram screening

Apple Watch Series 4 includes an electrocardiogram sensor to alert users if their heart rhythm is irregular, Apple COO Jeff Williams said during the company's Sept. 12 event in Cupertino, Calif.

Apple analyst Ming-Chi Kuo predicted the iPhone maker would integrate an ECG feature into its newest smartwatch in a Sept. 10 research note. Mr. Kuo is known for his strong track record of predicting new features in Apple products, according to CNBC.

At the time, the prediction raised questions about whether the consumer product would qualify as a medical device, which would require approval from federal regulators. However, at the event, Mr. Williams specified the FDA has already cleared the company's ECG sensor, CNBC's digital health reporter Christina Farr tweeted.

An ECG sensor goes beyond the Apple Watch's existing heart rate monitor by measuring a user's heart rhythm. The new Apple Watch will screen a user's heart health data in the background and deliver a notification when it detects patterns that appear to be atrial fibrillation, a type of irregular heart rhythm.

It's a noteworthy move for Apple, which has demonstrated interest in the cardiology space.

In late 2017, the company opened enrollment for a joint research project with Stanford University School of Medicine in California and telehealth vendor American Well to study whether the Apple Watch's heart rate sensor could detect atrial fibrillation.

The Apple Watch's ECG feature may hold implications for public health. Mr. Williams said Apple is the first company to offer consumers an over-the-counter ECG, which makes the technology available to a large segment of the population that may not be at risk for the condition.

"What are the implications of healthy, young people getting monitored with a heart rate sensor and ECG by a consumer device?" Ms. Farr asked on Twitter. "As far as I can tell, this will be the first time it's been studied."

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