Low Ejection Fraction AI Notification
Reads an ECG and flags patients whose hearts may be pumping weakly, before anyone has ordered a heart scan.
This is the cleverest trick in cardiovascular AI, and it is easy to explain.
Ejection fraction means how much blood the heart pushes out with each squeeze. Low is bad, treatable, and often silent for years. Measuring it normally needs an echocardiogram, which someone has to order, and nobody orders one for a patient with no symptoms.
An ECG is cheap, quick, and already done constantly. It is not supposed to reveal pumping strength. It turns out that trained models can pick up a signal in the trace that human readers do not see.
So the software reads ECGs that were taken for other reasons and quietly says this person may have a weak heart. Go check.
That is finding disease in tests you already ran, which is the most efficient thing AI does in medicine.
Clearances per Year
What the FDA Actually Signed Off On
- FDA product code
- QYE
- FDA name for it
- Reduced Ejection Fraction Machine Learning-Based Notification Software
- Rule number
- 21 CFR 870.2380
- Risk class
- Class 2
- Medical field
- Cardiovascular
Before You Sign Anything
- Ask what share of flagged patients turn out to have a low ejection fraction on echo. That ratio drives the whole business case.
- Ask how you will handle the echo volume the flags generate, because the flags arrive before the capacity does.
- Ask how the model performs in the age groups and populations you actually serve.
Who Holds the Most Clearances Here
| Company | Cleared products |
|---|---|
| Anumana, Inc. | 2 |
| BunkerHill Health | 1 |
| Tempus AI, Inc. | 1 |
| Eko Health, Inc. | 1 |
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 |
|---|---|---|---|
| Bunkerhill ECG-EF | BunkerHill Health | September 19, 2025 | K250649 |
| ECG-AI Low Ejection Fraction (LEF) 12-Lead algorithm (1010) | Anumana, Inc. | July 28, 2025 | K250652 |
| Tempus ECG-Low EF | Tempus AI, Inc. | July 15, 2025 | K250119 |
| Eko Low Ejection Fraction Tool (ELEFT) | Eko Health, Inc. | March 28, 2024 | K233409 |
| Low Ejection Fraction AI-ECG Algorithm | Anumana, Inc. | September 28, 2023 | K232699 |
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.