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Apple scores FDA clearance for heart rhythm-sensing Apple Watch

By Rachel Z. Arndt  | September 12, 2018

Apple has received clearance from the Food and Drug Administration for its latest Apple Watch, which can now conduct electrocardiograms and deliver alerts if atrial fibrillation is detected.

"This is the first ECG product offered over the counter, directly to consumers," said Apple chief operating officer Jeff Williams, announcing the Apple Watch Series 4 at an Apple event Sept. 12. "You can now take an ECG anytime, anywhere, right from your wrist."

To measure the heart's rhythms, a user presses their finger against a button on the watch. After 30 seconds, the watch delivers a heart rhythm classification, telling the user whether their rhythm is normal or atrial fibrillation. The data are stored in the Health app on the iPhone. From there, users can share the data in PDFs with their physicians.

The watch and heart rhythm alerts fall under the FDA's purview because they provide patients with ECG data.

"This is de novo clearance, which means it's the first of its kind," Williams said.

The data could ultimately be useful for Apple, said Chris Steel, global healthcare lead at PA Consulting.

"The analytics potential of a fully medical-grade ECG on every Apple watch users' wrist is significant, and would provide Apple with yet another hugely valuable data source on which to build additional services," he said.

Apple began making moves into heart rhythm detection in late 2017, when the company and Stanford Medicine launched a research study using the Apple Watch to identify irregular heart rhythms. That study relies on older models' heart-rate sensors, which send heart rhythm data to the Apple Heart Study app. If any of the data look like atrial fibrillation, the app notifies the wearer, who also gets a free consultation with a doctor via the American Well telehealth platform. Stanford is using the data collected in the study to look into using heart rate sensors and similar tools for precision health.