In a move that signals Apple’s ongoing push into digital health, the technology company announced today during its annual fall product event in Cupertino, California that its new Series 4 Apple Watch includes an electrocardiogram function as well as fall detection capabilities.
In a press release issued today, Apple said the Apple Watch Series 4 with watchOS 5 brings “advanced activity and communications features, along with revolutionary health capabilities, including a new accelerometer and gyroscope, which are able to detect hard falls, and an electrical heart rate sensor that can take an electrocardiogram (ECG) using the new ECG app, which has been granted a De Novo classification by the FDA (U.S. Food and Drug Administration).”
According to Jeff Williams, Apple’s chief operating officer, it is the “first-ever ECG app offered directly to consumers.” The addition of the ECG app means Apple won’t have to rely on third-party medical devices if the heart rate sensor detects an irregular result.
According to the FDA’s website, the de novo classification option was developed as a regulatory pathway for novel, low-risk medical devices. “The De Novo process provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device.” De Novo classification is a risk-based classification process, the FDA states.
According to Apple’s press release, the Apple Watch Series 4 enables customers to take an ECG reading right from the wrist using the new ECG app, which takes advantage of the electrodes built into the Digital Crown and new electrical heart rate sensor in the back crystal. With the app, users touch the Digital Crown and after 30 seconds, receive a heart rhythm classification.
The app can classify if the heart is beating in a normal pattern or whether there are signs of Atrial Fibrillation (AFib), a heart condition that could lead to major health complications, according to Apple. “All recordings, their associated classifications and any noted symptoms are stored in the Health app in a PDF that can be shared with physicians,” the company stated.
CNBC reporter Christina Farr, tweeting live from the Apple event, noted that Williams said the app won’t catch “every instance” of AFib.
One particular concern among cardiologists is whether use of the ECG app will lead to false positives and a rise in the number of "worried well" consumers. Ethan Weiss, M.D., a cardiologist with the University of California, San Francisco, tweeted in response to the Apple ECG app announcement: "I can’t figure out whether today is the best day in the history of Cardiology or the worst."
According to the FDA’s letter of approval for the do novo classification of the ECG app, the ECG app “determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.”
Also, in the letter it states, “The ECG app is intended for over-the-counter (OTC) use. 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 waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.” A FDA letter approving the photoplethysmograph analysis software as part of the Apple Watch noted that the feature "has not been tested for and is not intended for use in people under 22 years of age."
The ECG app builds on Apple’s previous work to incorporate heart rate tracking functions into the Apple Watch with a focus on detect arrhythmia and AFib. Last year, the company introduced its new Apple Watch Series 3 with enhanced health and fitness enhancements. The Apple Watch Series 3 included an updated Heart Rate app measuring heart rate during resting, workout, recovery and walking.
During last year’s event, the company also announced the Apple Heart Study, which uses data from Apple Watch to test if the heart rate sensors can detect cardiac arrhythmias, or abnormal heart rhythms, and possibly detect common heart conditions. Apple is currently working with Stanford Medicine on that research study in which the Apple Watch’s heart rate sensor is used to collect data on irregular heart rhythms and notify users who may be experiencing AFib. AFib, the leading cause of stroke, is responsible for approximately 130,000 deaths and 750,000 hospitalizations in the U.S. every year. Many people don’t experience symptoms, so AFib often goes undiagnosed.
According to Apple, the new Series 4 Apple Watch intermittently analyzes heart rhythms in the background and sends a notification if an irregular heart rhythm such as AFib is detected. It can also alert the user if the heart rate exceeds or falls below a specified threshold.
The Apple Watch’s fall detection function utilizes a next-generation accelerometer and gyroscope, which measures up to 32 g-forces, along with custom algorithms to identify when hard falls occur, the company stated. “By analyzing wrist trajectory and impact acceleration, Apple Watch sends the user an alert after a fall, which can be dismissed or used to initiate a call to emergency services. If Apple Watch senses immobility for 60 seconds after the notification, it will automatically call emergency services and send a message along with location to emergency contacts,” the company said in a press release.
