This week’s announcement that the US Food and Drug Administration (FDA) cleared two new features on the Apple Watch Series 4 is being met with a mixed response.
The redesigned watch includes a sensor that can take an electrocardiogram (ECG) reading in 30 seconds and classify whether the heart is beating normally or there are signs of atrial fibrillation (AF). The recordings are stored in the health app in a PDF file that can be shared with physicians.
With watchOS 5, the watch can also intermittently analyze heart rhythms and alert the user if it detects an irregular rhythm or if their heart rate exceeds or falls below a specified threshold, according to a company release.
The second app uses an accelerometer and gyroscope to determine and alert users if they have taken a hard fall. If the watch senses immobility for 60 seconds after the alert, it will automatically call emergency services and message the location to emergency contacts.
During its September 12 announcement of the redesign, Apple chief operating officer, Jeff Williams, described the watch as the «ultimate guardian for your health.»
Sharing the same stage, American Heart Association president, Ivor J. Benjamin, MD, said patients often report symptoms that are absent during office visits, and thus the ability to access on-demand ECG data is «game changing, especially when evaluating atrial fibrillation.» He also suggested that products that offer «deeper health insights,» such as Apple’s new heart-health features, have «great potential» to improve patients’ lifelong health and avoid stroke, heart failure, and other health problems.
Medscape editor-in-chief, Eric Topol, MD, Scripps Research Institute, La Jolla, California, cautioned that the ECG feature could increase the chance of false-positives and may detect cases of low-risk AF that don’t need to be treated.
On Twitter, he also noted that while the Apple watch captures heart rate, it does not measure oxygen saturation, blood pressure, or even breathing rate. Fitbit, however, is coming out with a watch that does measure oxygen saturation.
Medscape columnist and electrophysiologist John Mandrola, MD, from Baptist Health, Louisville, Kentucky, said the app could misdiagnose patients because of inaccurate readings or lead to overtreatment of patients.
On the positive side, he told theheart.org | Medscape Cardiology that «Over time, a decade or so, we may learn important things about arrhythmia from all this data. Similarly, people will gain more health literacy when it comes to their heart rhythm.»
Apple is not first in the medical surveillance arena, as AliveCor’s KardiaBand 30-second ECG app for the Apple Watch was cleared for personal use in November 2017.
The two devices will «definitely disrupt the heart rhythm monitoring industry,» Mandrola said.
«If you have a watch and want to correlate symptoms with a heart rhythm, this will be as effective as an MCOT [mobile cardiac output telemetry] or event recorder or perhaps a Holter,» he said, adding that an MCOT can cost hundreds if not thousands of dollars. The Apple Watch starts at $399.
«Consumers are now empowered to take more control of their own health information to make better informed decisions about their medical care and healthy living. These advances enable better health outcomes for patients,» FDA commissioner Scott Gottlieb, MD, and Center for Devices and Radiological Health director, Jeff Shuren, MD, said in a joint statement following Apple’s announcement and touting the agency’s work with the tech industry to spur innovations in digital health.
They go on to state: «These tools allow consumers and providers to supersede the traditional, physical constraints of health care delivery and make the most of the opportunities offered by mobile technology.»
The FDA gave the new Apple Watch features de novo, or first-of-its-kind, clearance, in a matter of weeks.
The ECG app can create, record, store, and transfer a single-channel ECG «similar to a Lead I ECG» and «determines the presence of atrial fibrillation or sinus rhythm on a classifiable waveform,» the FDA clearance letter states.
The ECG app is not recommended for users diagnosed with AF or for people under age 22 years.
The irregular heart rhythm feature is «not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis,» the agency states in its heart rhythm clearance letter.
It also notes that the data are captured only when the user is still and that the feature is «not intended to replace traditional methods of diagnosis or treatment.»
Apple’s splashy announcement has not gone unnoticed outside healthcare circles, with comedian Ellen DeGeneres joking that the watch will now charge owners a $40 copay for its ECG and is «perfect for people who like to drink.»
A Product Manager with expertise in pharma marketing and sales operations