Tempus ECG-Low EF
Overview
Tempus ECG-Low EF is an AI-powered software intended to analyze resting, non-ambulatory 12-lead ECG recordings. Its primary purpose is to detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). The software is designed for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older who are at risk of heart failure. This patient population includes, but is not limited to, individuals with conditions such as atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease.
Tempus ECG-Low EF provides a binary output for interpretation and is not intended to be a stand-alone diagnostic tool for cardiac conditions. It should not be used for patient monitoring or on ECGs with paced rhythms. Results from the software should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, other tests, symptoms, and clinical history. A positive result may suggest the need for further clinical evaluation, such as an echocardiogram, to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated according to current medical practice standards using all available clinical information.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-powered algorithm for ECG analysis
- Detects signs of low Left Ventricular Ejection Fraction (LVEF u226440%)
- Analyzes resting, non-ambulatory 12-lead ECG recordings
- Provides a binary output (Low LVEF Detected / Not Detected)
- Aids in identifying patients 40+ years at risk of heart failure
- Trained on a large dataset of over 930,000 ECGs from 170,000+ patients
- Intended for use in clinical diagnostic settings at healthcare facilities
Use Cases
- Early identification of patients at risk for serious cardiovascular conditions
- Supporting clinicians in the evaluation of patients for low LVEF
- Enhancing heart failure risk assessment in at-risk populations
- Guiding further clinical evaluation, such as echocardiograms
What Physicians Need to Know
Physicians should interpret Tempus ECG-Low EF results in conjunction with comprehensive clinical information, including the patient's original ECG, other diagnostic tests, symptoms, and clinical history. The tool is not a stand-alone diagnostic for low LVEF, nor should it be used for patient monitoring or to initiate therapy. A 'Low LVEF Detected' result warrants consideration of further diagnostic workup, such as an echocardiogram, and more frequent follow-up. The software is not validated for patients under 40 years of age or for ECGs with paced rhythms. A 'Low LVEF Not Detected' result does not rule out current or future low LVEF, and patients should continue to be evaluated according to standard medical practice.
Tempus ECG-Low EF is part of Tempus' suite of FDA-cleared ECG-AI devices and leverages EHR integrations to identify and filter eligible patients based on its intended use criteria. This allows for seamless integration into existing clinical workflows for identifying patients at risk for cardiovascular conditions.
Details
| Category | Cardiology AI |
| Pricing | Contact vendor |
| Deployment | Software, integrated into healthcare facility workflows |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Tempus ECG-Low EF received 510(k) clearance (K250119) from the U.S. Food and Drug Administration (FDA) on July 15, 2025. The clearance is for software that detects signs associated with having a low left ventricular ejection fraction (LVEF ≤40%) in resting, non-ambulatory 12-lead ECG recordings from patients 40 years of age or older at risk of heart failure. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Emergency Medicine, Internal Medicine |
What the Web Says
Tempus ECG-Low EF is an AI-powered software that analyzes 12-lead ECG recordings to identify patients aged 40 and older who may have a left ventricular ejection fraction (LVEF) of 40% or less, a key indicator for serious cardiovascular conditions. It received FDA 510(k) clearance in July 2025, making it Tempus's second FDA-cleared ECG-AI device. The software is intended to help clinicians identify at-risk patients earlier in their care journey, but it is not a standalone diagnostic tool and results should be interpreted with other clinical data.
Overall: PositiveStrengths
- Aids in early identification of patients at risk for serious cardiovascular conditions like heart failure, cardiomyopathy, or post-heart attack damage.
- Analyzes standard 12-lead ECG recordings, integrating into existing clinical workflows and EHRs.
- Second FDA-cleared ECG-AI device from Tempus, demonstrating a commitment to AI-driven cardiology.
- Trained on a large dataset of over 930,000 ECGs from more than 170,000 individuals.
- Can help uncover patterns in ECGs that may be missed by the human eye.
Limitations
- Not a standalone diagnostic tool; requires interpretation in conjunction with other clinical information.
- Should not be used for patient monitoring or on ECGs with paced rhythms.
- Not evaluated for patients younger than 40 years of age.
- A positive result suggests the need for further evaluation, not a definitive diagnosis.
- Some general employee reviews for Tempus AI (the parent company) mention a toxic work environment, poor pay, and lack of upward mobility, though these are not specific to the ECG-Low EF product.
- Not intended to replace other diagnostic tests or be used to initiate therapy.
Based on reviews from: Investing.com, Xtalks, Medical Product Outsourcing, Medical Device Network, 24X7mag, Practical Patient Care, accessdata.fda.gov, Tempus, BioSpace, PubMed, Eko Health, Indeed.com, Capterra
Last updated: 2026-07-20
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Tempus Scores FDA Clearance for AI ECG Software to Flag Low LVEF.
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