Tempus ECG-AF
Tempus
Analyzes 12-lead ECG data to estimate a patient's risk of developing atrial fibrillation within a defined future window, in patients not currently in AF.
At A Glance
- Manufacturer
- Tempus
- Medical specialty
- Cardiology
- Clearance route
- FDA authorized
- Year authorized
- 2024
- Modality
- ECG
- Role in workflow
- Risk prediction
Prediction is a harder regulatory and clinical category than detection, because the reference standard is an event that has not happened. A device that says a currently normal ECG carries elevated future risk cannot be validated against the present study, only against follow-up.
Where It Is Used
- Identifying candidates for rhythm monitoring
- Cryptogenic stroke workup prioritization
- Targeted anticoagulation assessment discussions
Limitations Worth Knowing
A risk score changes management only if there is an action attached to it, and the evidence that acting on predicted AF improves outcomes is still developing. Risk models also degrade when applied to populations unlike their training cohort, and cardiology cohorts skew heavily toward the populations that generate the most ECGs.
Regulatory status, indications, and labeling change over time. Confirm current status on the FDA's AI/ML-Enabled Medical Devices list and in the manufacturer's current instructions for use before relying on anything stated here.