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Whew! Apple Watch ECG was a heartbeat away from missing FDA nod

Whew! Apple Watch ECG was a heartbeat away from missing FDA nod
[Photo: courtesy of Apple]

Some on the Apple Watch team may have felt their hearts pounding in the days leading up to the big Apple Watch 4 unveiling in Cupertino last week. The new watch’s marquee health feature–an electrocardiogram–had not received a Food and Drug Administration clearance until within 24 hours of the device’s big coming-out.

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I overheard an Apple employee talking about the near-miss in exasperated tones outside the Steve Jobs Theater just after the press event. I understood the man’s anxiety better when I saw that the FDA’s classification letters to Apple were dated September 11. Apple’s event was September 12.

During the presentation, Apple COO Jeff Williams proudly announced that the Watch 4’s ECG tech had received a de novo clearance from the FDA. “This is the first ECG product offered over the counter directly to consumers,” he said. He wouldn’t have been able to say any of that had the FDA’s letter not come in. (And, for the record, Apple’s ECG isn’t the first–that honor goes to AliveCor.)

Asked why the letter came in at the last minute, Apple offered no comment.

About ECG

Earlier Apple Watches had an optical sensor (called photoplethysmogram, or PPG) that watches the blood flow in the wrist to derive a heart rate. An electrocardiogram is very different–it measures the electrical signals that cause the chambers of the heart to contract in the carefully orchestrated sequence that circulates the blood. An ECG can also detect all kinds of arrhythmias, which can be serious business, hence the involvement of the FDA.

According to copies of the letters sent to Apple, which are available at the FDA’s website, the agency actually reviewed a notification feature and an app, not the watch’s ECG hardware itself.

The first app, called the “Irregular Rhythm Notification Feature,” looks at the Apple Watch wearer’s heartbeat rhythm and can send a notification if it detects patterns reminiscent of atrial fibrillation or some other arrhythmia.

The second app, which the FDA calls electrocardiograph software for over-the-counter use, creates an electrocardiograph and provides analysis on whether it shows signs of cardiac arrhythmias. “This device is not intended to provide a diagnosis,” the letter states.

The FDA also puts some clear limitations on how the app should be used.

“The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional . . . The ECG app is not intended for use by people under 22 years old.”

Some in the medical community have already expressed concerns that Apple Watch wearers might draw false positives from the app, leading to unnecessary doctor calls or visits, or even trips to the ER.

Some of those same worries have been expressed by caregivers about AliveCor’s Kardia Band, which was also reviewed by the FDA and came to market in 2016. AliveCor also has a Kardia Band for Apple Watch, which creates an ECG after the band wearer rests a finger on a sensor pad built into the watch band.

The new Apple Watch 4 will not ship with the ECG app when it goes on sale September 21. That will be added in an over-the-air update sometime later this year. The FDA classification, at least, allowed Apple to begin marketing the product.

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