Apple—Apple Watch received FDA clearance for ECG and atrial fibrillation detection, first consumer device to offer OTC heart monitoring
In September 2018, Apple received FDA clearance for the Apple Watch Series 4 with electrocardiogram (ECG) capability, making it the first consumer device to offer over-the-counter heart rhythm monitoring. The ECG feature achieved 99.3% specificity and 98.5% sensitivity for detecting atrial fibrillation. The Stanford-partnered Apple Heart Study validated the approach. In 2024, the FDA approved Apple Watch's heart monitoring tool for use in clinical trials under the Medical Device Development Tools (MDDT) program — the first digital health tool to receive this qualification. The feature has been credited with detecting previously undiagnosed heart conditions in users worldwide.
Scoring Impact
| Topic | Direction | Relevance | Contribution |
|---|---|---|---|
| Healthcare Access | +toward | primary | +1.00 |
| Overall incident score = | +0.885 | ||
Score = avg(topic contributions) × significance (high ×1.5) × confidence (0.59)
Evidence (1 signal)
FDA cleared Apple Watch ECG for atrial fibrillation detection with 99%+ accuracy
Apple received FDA clearance for the Apple Watch Series 4 ECG app in September 2018, making it the first consumer over-the-counter electrocardiogram device. The ECG achieved 99.3% specificity and 98.5% sensitivity for AFib detection. The Stanford-partnered Apple Heart Study validated the approach. In 2024, FDA approved it for clinical trial use under the MDDT program — the first digital health tool qualified.