Is Apple Watch ECG FDA Approved?

What is Apple’s ECG app called?

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG.

The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform..

Is Apple Watch FDA approved?

The Apple Watch Series 4 has received clearance from the U.S. Food and Drug Administration to operate as an over-the-counter ECG-monitoring device, becoming the first device available to consumers over the counter to offer the functionality.

Is ECG on Apple watch accurate?

The ability of the ECG app to accurately classify an ECG recording into AFib and sinus rhythm was tested in a clinical trial of approximately 600 subjects, and demonstrated 99.6% specificity with respect to sinus rhythm classification and 98.3% sensitivity for AFib classification for the classifiable results.

Is the ECG app available for Apple Watch?

Apple on Thursday released its ECG app for the Apple Watch Series 4 via a software update. The ECG app uses the watch’s digital crown and sensors along the bottom of the watch to monitor the electrical patterns of your heartbeat and analyzes it for potential issues.

Can Apple Watch 3 detect irregular heartbeat?

The irregular rhythm notification feature on your Apple Watch will occasionally look at your heartbeat to check for an irregular rhythm that might be suggestive of atrial fibrillation (AFib). … Irregular rhythm notifications are currently available only in certain countries and regions.

Can Apple Watch detect heart palpitations?

The Apple Watch can only detect irregular heart rhythms, which are a risk factor for stroke. As Apple’s website states: The ECG app can’t detect a heart attack, blood clots, stroke or other heart-related conditions, including high blood pressure, congestive heart failure, high cholesterol or other forms of arrhythmia.