ANNOUNCING FDA 510(K) CLEARANCE FOR TEMPUS ECG-LOW EF /// READ MORE ANNOUNCING FDA 510(K) CLEARANCE FOR TEMPUS ECG-LOW EF /// READ MORE
ORDER A TEST Log In Contact Us
Tempus ECG-AI Solutions

Tempus accelerates cardiac care with AI-powered solutions designed to support clinicians in identifying patients who may be at risk for a variety of cardiovascular conditions.

Schedule a demo
image description image description

Tempus ECG-AI devices integrate with advanced cardiology algorithms to detect signs associated with certain cardiovascular conditions and notify care teams for patient follow up

  • Step 1: Patient Filtering
    Step 1: Patient Filtering

    Tempus employs EHR integrations and patient clinical data to filter patients that may be eligible for Tempus ECG-AI device use based on IFU criteria.

  • Step 2: Patient Diagnosis
    Step 2: Patient Diagnosis

    Tempus is pursuing development of Tempus ECG-AI based cardiology algorithms that can analyze physiological inputs using machine learning models, and detect signs associated with certain cardiovascular conditions for further referral or diagnostic follow-up.

  • Step 3: Patient Follow Up
    Step 3: Patient Follow Up

    Tempus uses AI to identify and contextualize patients in their journey, surface precision pathways at the point of care and track patients for further referral or diagnostic follow-up consistent with clinical care guidelines.

FDA Cleared, Tempus ECG-AI Devices

All Tempus ECG-AI solutions are designed to work with existing ECG platforms and EHRs to enable advanced AI deployment  and insights within clinical workflows.

Tempus ECG-AF

Intended Use

Tempus ECG-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation or flutter within the next 12 months.  Tempus ECG-AF is for use on resting 12-lead ECGs from patients 65 years and older without pre-existing or concurrent documentation of AF, who do not have a pacemaker or ICD, and who did not have cardiac surgery in the preceding 30 days.1

Learn more

Algorithm Design

The Tempus ECG-AF model was trained on data from >1,500,000 ECGs and >450,000 patients.2

Results

For patients receiving a positive result from the Tempus ECG-AF test, AF would be observed in approximately 1-in-5 patients within the next 12 months.1

Tempus ECG-Low EF

Intended Use

The Tempus ECG-Low EF is software intended for use to analyze 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF ≤40%) in patients 40 years of age or older at risk of heart failure. It is not intended as a stand-alone diagnostic and positive results may suggest the need for further clinical evaluation.3

Learn more

Algorithm Design

The Tempus ECG-Low EF model was trained on data from >930,000 ECGs and >170,000 patients.3

Results

For patients receiving a positive result from the Tempus ECG-Low EF test, LVEF (≤40%) would be observed in approximately 2-in-5 patients when tested by echocardiogram.3

CPT Coding for ECG-AI Devices

  • Effective January 1, 2025, CPT4 +0764T and 0765T are listed under the Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS) as Category III codes to describe assistive algorithmic electrocardiogram assessments for cardiac dysfunction.

    Learn more
image description

Predictive ECG Algorithms for Undiagnosed Disease

Tempus’ portfolio aims to support clinicians in identifying patients who may be at risk for a variety of cardiovascular conditions.

image description image description

Pipeline current as of 7/2025

OUR RESEarch

Advancing cardiac care through algorithm development, validation, and scaled clinical adoption.

ALERT Study: Addressing undertreatment and health equity in aortic stenosis and mitral regurgitation using an integrated EHR platform

ACTIVE STUDY

This multi-center, prospective, cluster-randomized controlled trial will evaluate automated notifications as an intervention to support identification and evaluation of patients possibly indicated for a transcatheter or surgical procedure to treat aortic stenosis or mitral regurgitation.

Learn more

MOMENTOUS Study: Assessing the clinical impact of an ECG algorithm to increase the diagnosis of pulmonary hypertension

ACTIVE STUDY

Tempus is sponsoring a multi-site study of an investigational AI algorithm that analyzes the results of a 12-lead electrocardiogram (ECG) to find patients at increased risk of having undetected pulmonary hypertension (PH). Clinicians will evaluate the AI’s ability to detect patients at risk of undiagnosed PH, and will track clinical outcomes of patients who are identified for further evaluation.

Learn more

NOTABLE Study

ACTIVE STUDY

The NOTABLE (NOrthwestern Tempus AI-enBLed Electrocardiography) study will examine rates of new disease diagnosis, therapeutic interventions, and cardiovascular outcomes in patients managed by clinicians at Northwestern Medicine who use ECG predictive models compared to patients managed by clinicians at Northwestern Medicine who do not use the ECG predictive models.

Learn more

ECG AID Study

CLOSED FOR RECRUITING

This study, which recently completed enrollment, will investigate the prospective performance of our algorithms for atrial fibrillation and structural heart disease.

Learn more

Research as a service

Automated methods to find patients indicated for trials.

Publications and conference abstract support.

Learn more about joining a study or partnering with Tempus on research.

Learn more
image description

Featured News and Content

view all news
  • UPCOMING WEBINAR:

    Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-Low EF Software

    Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-Low EF (ejection fraction) algorithm, which uses AI to detect signs associated with having a low left ventricular ejection fraction (LVEF ≤40%) in patients 40 years of age or older at risk of heart failure.

    Link
  • UPCOMING WEBINAR:

    The Cardiac Wire Show: Improving Diagnosis and Care with ECG and AI

    In the latest Cardiac Wire Show, Tempus AI’s Chris Scotto DiVetta explores how AI-based analysis of ECG and EHR data can help identify more at-risk patients and bridge gaps in cardiovascular care pathways.

    Link
  • UPCOMING WEBINAR:

    AI algorithms in cardiology: Navigating the path from research to practice

    Speakers David Ouyang, MD from Cedars Sinai and Brandon Fornwalt, MD PhD and John Pfeifer, MD, MPH from Tempus discussed the importance of ECG AI algorithms, the journey through algorithm development and validation and the implications for cardiology clinical practice.

    Watch replay
  • UPCOMING WEBINAR:

    Tempus Receives U.S. FDA 510(k) Clearance for Tempus ECG-AF, an AI-based Algorithm that Identifies Patients at Increased Risk of AFib

    Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Tempus ECG-AF device that uses AI to help identify patients who may be at increased risk of atrial fibrillation/flutter (AF).

    Link
  • UPCOMING WEBINAR:

    New CMS Decision Provides Medicare Coverage for the Clinical Use of the Tempus ECG-AF Device

    Tempus AI, Inc. (NASDAQ: TEM), a technology company leading the adoption of AI to advance precision medicine and patient care, today announced the impact of a new decision by the Centers for Medicare and Medicaid Services (CMS) that will allow reimbursement for assessments of cardiac dysfunction using the Tempus ECG-AF algorithm.

    Link
  • UPCOMING WEBINAR:

    Tempus and Northwestern Medicine Announce Collaboration to Bring Practical Application of AI to Healthcare

    Tempus, a leader in artificial intelligence and precision medicine, and Northwestern Medicine, Chicago’s premier integrated academic health system, today announced a collaboration that aims to explore the application of artificial intelligence in clinical care and research.

    Link

Our Science

view all
  • UPCOMING WEBINAR:

    Enhancing Diagnostic Accuracy and Treatment Appropriateness in Cardiac Transthyretin Amyloidosis Through Natural Language Processing: A Retrospective Analysis

    Read more
  • UPCOMING WEBINAR:

    Development of Machine Learning Models Incorporating Clinical, Demographic, and Echocardiography Variables for Predicting Left Ventricular Systolic Dysfunction in Patients With Isolated Left Ventricular Dilation

    Read more
  • UPCOMING WEBINAR:

    Implementation of EHR-Integrated Notifications on Patients at Risk for Sudden Cardiac Arrest. Kelley, T, Rink, C, Sotelo, M. et al.

    Read more
  • UPCOMING WEBINAR:

    Development and validation of a moderate aortic stenosis disease progression model

    Read more
  1. INDICATIONS FOR USE: Tempus ECG-AF is intended for use to analyze recordings of 12-lead ECG devices and detect signs associated with a patient experiencing atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the next 12 months. It is for use on resting 12-lead ECG recordings collected at a healthcare facility from patients: 65 years of age or older, without pre-existing or concurrent documentation of atrial fibrillation and/or atrial flutter, who do not have a pacemaker or implantable cardioverter defibrillator, and who did not have cardiac surgery within the preceding 30 days. Performance of repeated testing of the same patient over time has not been evaluated and results SHOULD NOT be used for patient monitoring. Tempus ECG-AF only analyzes ECG data. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. Tempus ECG-AF is not for use in patients with a history of AF, unless the AF occurred after a cardiac surgery procedure and resolved within 30 days of the procedure. It is not for use to assess risk of occurrence of AF related to cardiac surgery. Results do not describe a person’s overall risk of experiencing AF or serve as the sole basis for diagnosis of AF, and should not be used as the basis for treatment of AF. Results are not intended to rule-out AF or the need for follow-up. Link to IFU: https://www.tempus.com/ifu-ecg-af/
  2. Raghunath, S., Pfeifer, J. M., Ulloa-Cerna, A. E., Nemani, A., Carbonati, T., Jing, L., vanMaanen, D. P., Hartzel, D. N., Ruhl, J. A., Lagerman, B. F., Rocha, D. B., Stoudt, N. J., Schneider, G., Johnson, K. W., Zimmerman, N., Leader, J. B., Kirchner, H. L., Griessenauer, C. J., Hafez, A., … Haggerty, C. M. (2021). Deep neural networks can predict new-onset atrial fibrillation from the 12-lead ECG and help identify those at risk of atrial fibrillation-related stroke. Circulation, 143(13), 1287–1298. https://doi.org/10.1161/CIRCULATIONAHA.120.047829
  3. INDICATIONS FOR USE: Tempus ECG-Low EF is software intended to analyze resting, non-ambulatory 12-lead ECG recordings and detect signs associated with having a low left ventricular ejection fraction (LVEF less than or equal to 40%). It is for use on clinical diagnostic ECG recordings collected at a healthcare facility from patients 40 years of age or older at risk of heart failure. This population includes but is not limited to patients with atrial fibrillation, aortic stenosis, cardiomyopathy, myocardial infarction, diabetes, hypertension, mitral regurgitation, and ischemic heart disease. Tempus ECG-Low EF only analyzes ECG data and provides a binary output for interpretation. Tempus ECG-Low EF is not intended to be a stand-alone diagnostic tool for cardiac conditions, should not be used for patient monitoring, and should not be used on ECGs with paced rhythms. Results should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings and other tests, as well as the patient’s symptoms and clinical history. A positive result may suggest the need for further clinical evaluation in order to establish a diagnosis of low LVEF. Patients receiving a negative result should continue to be evaluated in accordance with current medical practice standards using all available clinical information. Link to IFU: https://www.tempus.com/ifu-ecg-low-ef/
  4. CPT® Copyright 2024 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. Applicable FARS/DFARS Restrictions Apply to Government Use. Fee schedules, relative value units, conversion factors, and/or related components are not assigned by the AMA, are not part of CPT®, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein.

Partnering with Tempus is investing in the future

We believe that AI-enabled solutions can help shorten the diagnostic odyssey and improve the lives and outcomes of patients with cardiovascular disease.