My watch flagged an irregular rhythm
What FDA's 2018 summary says one watch feature is for, what studies of watch alerts measured, how the sources describe checking for atrial fibrillation, and questions to ask a clinician.
Signs the sources say need care
From the MedlinePlus arrhythmia page
- MedlinePlus lists chest pain among the symptoms of an arrhythmia.1
- MedlinePlus also lists shortness of breath among the symptoms of an arrhythmia.2
“Seek emergency medical care if you have chest pain, shortness of breath, or think you are having a heart attack.”3
In an emergency, call your local emergency number.
What FDA's 2018 summary says about the feature
- FDA granted a De Novo request from Apple for software that sends irregular rhythm notifications on the Apple Watch, with a decision date of September 11, 2018.4, 5, 6
- The summary says the Apple Watch software studies pulse data and sends a notification, here called an alert, when it spots an irregular rhythm that may point to atrial fibrillation (AFib).7, 8
- It labels the feature as over-the-counter.9
- It calls the feature a tool that screens in the background and says a user cannot start a check.10
- It says the data are captured only while the wearer is still.11
- In this 2018 description, an alert appears when five of six readings in a row, within 48 hours, are classified as irregular.12
- The summary says the alert also encourages users who were not previously diagnosed with AFib to seek medical care.13
- It says the phone app shows a record of past AFib alerts and a list of when the irregular readings behind each one were taken.14, 15
- It says the feature was not tested in people under 22, and that it is not meant for them or for people previously diagnosed with AFib.16, 17
- It adds that the feature, together with a person's risk factors, can help inform the decision about AFib screening.18
- It says the feature is not meant to replace usual diagnosis or treatment, and not meant to guide clinical care.19, 20
- FDA's description of this type of device adds that such a device is not meant to diagnose.21
What the 2018 summary says an alert cannot tell
- The labeling text in the summary calls an alert a possible finding, not a full diagnosis of heart conditions.22
- That text also says a medical professional should review all alerts.23
- The summary also says the labeling states that an AFib diagnosis should still rest on confirmation by ECG.24
- The summary says the feature is not meant to give an alert for every irregular episode, and a missing alert is not meant to show that no disease is present.25
- The labeling text says the feature does not look for AFib all the time, so it cannot find every instance and some people with AFib may get no alert.26, 27
- The labeling text also says the feature is unable to detect a heart attack.28
- The labeling text lists motion, hand and finger movement, dark wrist tattoos, and blood flow to the skin, which cold can reduce, among factors that can affect the pulse measurement.29, 30
- The summary names a probable risk that users will misread the output and ignore acute symptoms, such as those of a heart attack.31
- It also says users may take the output as permission to avoid following a treatment already prescribed for a long-term heart condition.31
What studies of watch alerts measured
- The Apple Heart Study used its own research app, and this guide's sources do not say how that app, or the study, relates to the clinical study in the FDA summary.32
- The Apple Heart Study recruited 419,297 people who reported having no atrial fibrillation, and a smartwatch program looked for an irregular pulse.33, 34, 35
- Over a median of 117 days of monitoring, 2161 people (0.52%) received a notification of an irregular pulse from the study's app.36, 37
- Of the 450 notified people who returned usable ECG patch data, 34% (97.5% confidence interval, 29 to 39) had atrial fibrillation on the patch, which was applied on average 13 days after the notification.37, 38, 39
- Of 1376 people who got a notification from the study's app and returned a 90-day survey, 57% contacted health care providers outside the study.40
- The study's registry entry lists a single study group.41
- Its registry entry lists four outcomes, about atrial fibrillation of more than 30 seconds, confirmed atrial fibrillation, agreement with the app's notification, and contact with a health care provider.42, 43, 44, 45
- None of the four outcomes is about strokes.42, 43, 44, 45
- In a sub-study described in the FDA summary, the result for single irregular readings did not reach the accuracy goal set before the study.46
- FDA still judged the secondary and further analyses to support the feature's effectiveness in detecting AFib.47
- In an analysis added after the study's plan, of 226 people who already had notifications from the feature, AFib was documented on later 7-day patch monitoring in 41.6% (95% CI, 35.1 to 48.3).48
- FDA wrote that this feature is not meant to diagnose AFib but is an accessible tool for finding people who would probably gain from more AFib screening using ECG-based methods.49
How the sources describe checking for atrial fibrillation
- MedlinePlus says some people who have AFib have no symptoms and do not know they have it.50
- MedlinePlus says AFib may happen in brief episodes, or it may be a permanent condition.51
- NHLBI says a provider reaches a diagnosis of atrial fibrillation using the patient's history and a physical exam, along with an EKG and, in some cases, other tests.52
- NHLBI says an EKG records the electrical activity of the heart.53
- NHLBI says Holter and event monitors are portable EKG devices that record over long periods of everyday activity.54
- It says they can help explain symptoms such as palpitations or dizziness that occur away from the provider's office.54
- NHLBI also says that several devices can now detect and record heart rhythm in a way similar to an EKG, and that readings from these devices may be emailed to a provider.55
- MedlinePlus says a provider will ask about medical history, including symptoms, lifestyle and other health conditions, and about relatives who have or had AFib.56, 57
- MedlinePlus says a provider will likely order heart tests such as an electrocardiogram (“also called an EKG or ECG”) and an echocardiogram, and may ask the patient to wear a heart monitor.58, 59
What MedlinePlus lists as symptoms of an arrhythmia
What a national task force said about screening
- In 2022, the USPSTF found the evidence too limited to judge whether screening for atrial fibrillation does more good than harm, which it calls an I statement.66
- The statement covers adults 50 or older with no atrial fibrillation diagnosis or symptoms and no earlier stroke or transient ischemic attack.66
What the sources say a provider asks about or uses
- A record of how often and when symptoms occur, what is felt and whether this changes over time, which NHLBI calls important clues for diagnosis.67, 68
- Heart rhythm readings from a device, which NHLBI says may be emailed to a provider.55
- Medical history, including symptoms, lifestyle and other health conditions, which MedlinePlus says a provider will ask about.56
- Family history of AFib, which MedlinePlus says a provider will ask about.57
Questions to ask
- Does my watch alert point to atrial fibrillation, and which test would confirm it?
- The FDA summary says the feature is not meant for people under 22 or people already diagnosed with AFib; does that apply to me?
- If my watch gives no alert, does that say anything about my heart?
- Would an EKG, a heart monitor or another test help sort out what the alert found?
- Would the history of alerts on my phone, or a record of my symptoms, help you?
- Can readings from my device be sent to you, and in what form?
- Do the results of the Apple Heart Study apply to someone like me?
- Does the 2022 task force statement on screening change anything for me?
Sources
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)
- FDA De Novo DEN180042: Irregular Rhythm Notification Feature (openFDA record)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
-
Applies to Adult
- People aged 22 or older who lived in the United States, owned a compatible iPhone and Apple Watch, had no self-reported diagnosis of atrial fibrillation or atrial flutter, and were not on anticoagulation therapy (registry exclusion criteria).
- Remote and siteless. People consented and took part through a smartphone app with no on-site visits. After a notification, the study started a telemedicine visit and mailed an ECG patch to the participant.
- United States (the registry lists only the United States as a country)
- Adults aged 22 or older (registry minimum age). The abstract reports one result separately for participants aged 65 or older.
Limitations. Single-group study with no comparison group, using the study's own research app. The result is not about the FDA-authorized feature itself, and the sources read do not say how the two relate. The registry lists as outcomes the share of notified participants with AF on the ECG, agreement between the app and the ECG, and contact with a health care provider. It lists no stroke or other clinical outcome, so the study does not show that notifications prevent strokes. Only 450 of the 2161 notified participants returned analyzable patches. The abstract gives the 34% (97.5% CI) and the 0.84 (95% CI) as separate measures, and they are not the same quantity. The registry enrollment (419927) and the abstract recruitment count (419,297) differ and are not reconciled. Participants were self-selected owners of a compatible phone and watch, and the abstract does not describe their health or demographics. Abstract only; the PMC copy is not in the Open Access subset and the full text was not read.
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Supports Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Background Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Background Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Background Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Background Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Background Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Background Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Large-Scale Assessment of a Smartwatch to Identify Atrial Fibrillation
- Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- Apple Heart Study: Assessment of Wristwatch-Based Photoplethysmography to Identify Cardiac Arrhythmias
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- De Novo Classification Request for Irregular Rhythm Notification Feature (FDA decision summary, DEN180042)
- Atrial Fibrillation | AFib (MedlinePlus)
- Atrial Fibrillation | AFib (MedlinePlus)
- Atrial Fibrillation Diagnosis (NHLBI)
- Atrial Fibrillation Diagnosis (NHLBI)
- Atrial Fibrillation Diagnosis (NHLBI)
- Atrial Fibrillation Diagnosis (NHLBI)
- Atrial Fibrillation | AFib (MedlinePlus)
- Atrial Fibrillation | AFib (MedlinePlus)
- Atrial Fibrillation | AFib (MedlinePlus)
- Atrial Fibrillation | AFib (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
- Arrhythmia | Irregular Heartbeat (MedlinePlus)
-
Applies to Adult
- Adults aged 50 or older with no diagnosis or symptoms of atrial fibrillation and no earlier transient ischemic attack or stroke, as the abstract defines the population. The abstract describes the recommendation as concerning asymptomatic adults.
- Not stated in the abstract.
- United States (a USPSTF recommendation)
- Adults aged 50 or older
Limitations. An I statement means the evidence is too thin to support a recommendation either way. It is not advice against screening, and it does not say that screening finds nothing or that anticoagulation does not help. The statement updates a 2018 recommendation. Only the PubMed abstract and the date line of the USPSTF page were read. No recommendation record is written, because this atlas has no record for atrial fibrillation screening itself.
- Supports Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement
- Supports Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement
- Supports Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement
- Background Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement
- Background Screening for Atrial Fibrillation: US Preventive Services Task Force Recommendation Statement
- Atrial Fibrillation Symptoms (NHLBI)
- Atrial Fibrillation Symptoms (NHLBI)
About this guide
- Written for
- Adults whose smartwatch has flagged an irregular rhythm, and the people with them
- What it covers
- Written from an FDA summary, a study abstract, a registry entry, a task force statement and four US government health pages. The FDA summary covers one 2018 authorization, for Apple's feature. Other watches and later versions of the feature are not covered. The guide describes what the sources say. It gives no advice for one person.
- Pages it explains
- Sources checked
- 2026-10-15
- Next check due
- 2027-04-15
- Reading level
- Estimated grade 9.9
Every sentence cites a source. Words in quotation marks are the source's own; the rest is the atlas's summary.
https://cardio.openmedicalatlas.org/guides/watch-irregular-rhythm/ · Release f4600233112e1c27, built 2026-10-15