Atrial Fibrillation Risk Prediction AI
Predicts which patients are likely to develop an irregular heartbeat, before it has happened.
Read the device name twice, because it says something unusual: risk prediction.
Most cleared AI finds something that is already present. This is cleared to say a patient looks likely to develop atrial fibrillation in the future, when they do not have it yet.
That matters because atrial fibrillation causes strokes, and a stroke prevented is worth more than a stroke treated well.
It also raises a fair question that the clearance does not answer for you. What do you do with a person who has an elevated risk and no condition? That is a clinical policy decision, and it should be made before the software is switched on.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- SBQ
- FDA name for it
- Atrial Fibrillation Risk Prediction Machine Learning-Based Notification Software
- Rule number
- 21 CFR 870.2380
- Risk class
- Class 2
- Medical field
- Cardiovascular
Before You Sign Anything
- Ask what the prediction window is. Likely within twelve months and likely within five years call for very different responses.
- Ask what the recommended action is for a flagged patient, and who signs it off locally.
- Ask how the model was validated for people who were already on heart medication.
Every Cleared Product, Newest First
Each row links to the FDA's own record. The number in the last column is the clearance number, which is the single best thing to ask a vendor for.
| Product | Company | Cleared | FDA record |
|---|---|---|---|
| Tempus ECG-AF | Tempus AI, Inc. | June 21, 2024 | K233549 |
Clearance data comes from the FDA's public 510(k) and device classification records through openFDA. A clearance means the FDA agreed the product is close enough to something already on the market, not that the FDA tested it in your hospital. It says nothing about accuracy in your patient mix, your scanners, or your workflow. Confirm the current status and the exact cleared indication on the FDA record before you buy.