Apple's latest ECG-monitoring watch: 12 things to know

Apple revealed the Apple Watch Series 4 will be equipped with an electrocardiogram monitor during its Sept. 12 event. However, many cardiologists have expressed concern over the move.

Here are 12 things to know:

1. The ECG app represents a step up from the Apple Watch's existing heart rate monitor in that it can now measure a user's heart rhythm, and can notify them when it detects patterns in their heart data that appear to be atrial fibrillation, a type of irregular heart rhythm. The watch is also able to send a wearer's heart data to a physician via PDF.

2. Apple COO Jeff Williams noted during the event  the new feature won't catch "every instance" of AFib.

3. Apple claimed the newest watch would be the first FDA-cleared over-the-counter ECG device available to consumers, The New York Times reports. However, the publication noted, "Apple may want to check its claim of being first, as other companies said they had been ahead of it with the agency in this regard."

4. Apple said the ECG feature "has been granted a De Novo classification by the FDA," according to a tweet from Buzzfeed News tech reporter Nicole Nguyen. The De Novo classification allows Apple to market the product without full medical device approval for new, low- and moderate-risk applications.

5. Epstein Becker Green's Bradley Thompson told the Politico Morning eHealth newsletter the time it took the FDA to grant Apple its clearance was remarkable. Apple filed its ECG sensor application on Aug. 14, and the application for a system that notifies the wearer of irregular heartbeats on Aug. 9. "FDA cleared not one but two Apple de novo reviews in fewer than 30 days," he told the publication, adding FDA's aims to issue decisions for half of these applications within 150 days of receipt.

6. "FDA worked closely with Apple as they developed and tested these apps, which may help many users identify health concerns more quickly. Healthcare products on smart watches may help users seek treatment earlier and will empower patients with more information about their health," FDA Commissioner Scott Gottlieb, MD, tweeted.

7. According to the FDA's approval letter for the ECG app, the software is not intended for people under the age of 22, and users are "not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional."

8. Shortly after Apple's announcement, physicians took to Twitter to express a mix of emotions. Carmen Peralta, MD, a nephrologist and CMO of Cricket Health, tweeted: "Our patients are at extremely high risk for sudden death, arrhythmia and hyperkalemia. They're already anxious about [Apple's ECG feature]. I am concerned about false positives and visits to ER in this population. Need data on sens/spec."

9. Another physician, Bob Watcher, MD, chair of the department of medicine at UC San Francisco, agreed with Dr. Peralta: "Similar concerns and excitement — knowing minute-to-minute heart rate variations in intensive care unit patients is sometimes useful. Whether it is in healthy 30-year-olds is an unproven hypothesis and should be tested. Likely to be tons of false positives, which will drive anxiety and some overtreatment."

10. In addition to its enhanced heart health capabilities, the new watch can detect when a wearer has fallen down, a leading cause of injuries. If a wearer falls, the watch prompts the wearer to alert emergency services, and if it doesn't detect any motion after one minute, automatically initiates an emergency call.

11. The announcement possibly builds off a project Apple jointly launched with the Stanford University School of Medicine in California and telehealth vendor American Well in 2017. The project was designed to study whether the Apple Watch's heart rate sensor could detect AFib. Apple recently told some early participants that it had completed their data collection for the study, but that the study will continue until Jan. 1, 2019.

12. Fitbit stock dropped more than 4 percent following the Apple Watch announcement, according to CNBC.

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