Tempus ECG-AF
Overview
Tempus ECG-AF is an AI-based algorithm intended for use in analyzing recordings of 12-lead electrocardiogram (ECG) devices. Its primary purpose is to detect signs associated with a patient experiencing new onset atrial fibrillation and/or atrial flutter (collectively referred to as AF) within the subsequent 12 months.
The device is specifically designed for use on resting 12-lead ECG recordings collected at a healthcare facility from patients who are 65 years of age or older. Eligible patients must not have pre-existing or concurrent documentation of atrial fibrillation or atrial flutter, nor should they have a pacemaker or implantable cardioverter defibrillator, or have undergone cardiac surgery within the preceding 30 days.
Tempus ECG-AF only analyzes ECG data and provides results that should be interpreted in conjunction with other diagnostic information, including the patient’s original ECG recordings, other tests, symptoms, and clinical history. It is not intended to be a standalone diagnostic tool for AF, nor should its results be used as the sole basis for AF diagnosis or treatment. The device is also not for use in patients with a history of AF (unless post-cardiac surgery and resolved within 30 days) or to assess AF risk related to cardiac surgery.
The algorithm was developed using machine learning techniques trained on an extensive dataset of over 1.5 million ECGs from more than 500,000 patients across multiple hospitals and clinics. It is compatible with FDA authorized resting 12-lead ECGs from GE Medical Systems and Philips Medical Systems.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-based algorithm for 12-lead ECG analysis
- Detects signs associated with new onset Atrial Fibrillation (AF) within 12 months
- Intended for patients 65 years or older without pre-existing AF, pacemakers, ICDs, or recent cardiac surgery
- Results interpreted in conjunction with other diagnostic information and clinical history
- Compatible with FDA authorized resting 12-lead ECGs from GE Medical Systems and Philips Medical Systems
- Trained on over 1.5 million ECGs from over 500,000 patients
Use Cases
- Early identification of patients at increased risk for new onset AF
- Supporting clinicians in considering the need for follow-up to detect AF
- Reducing underdiagnosis of AF to prevent AF-related complications like stroke
- Integrates with EHR and patient clinical data for filtering eligible patients
- Facilitating precision pathways at the point of care
- Tracking patients for further referral or diagnostic follow-up consistent with clinical care guidelines
What Physicians Need to Know
Tempus ECG-AF is an FDA-cleared AI tool designed to identify patients aged 65 or older without a known history of AF who are at increased risk of developing AF within the next 12 months. It serves as a valuable screening tool to proactively identify at-risk individuals, enabling earlier intervention and management. Physicians should interpret the results in conjunction with the patient's original ECG recordings, other diagnostic information, symptoms, and clinical history, as it is not intended as a standalone diagnostic tool or the sole basis for treatment decisions. It should not be used for patients with a history of AF (unless specific post-cardiac surgery conditions are met) or for patient monitoring.
Tempus ECG-AF integrates with existing medical systems, including Electronic Health Record (EHR) systems and hospital information systems. It receives input data, such as 12-lead ECG tracings, patient age, and sex, via standard communication protocols like API and file exchange. The analysis results ('increased risk,' 'no increased risk,' or 'unclassifiable') are then returned to these systems for display to clinicians, streamlining the workflow for identifying at-risk patients.
Details
| Category | Cardiology AI |
| Pricing |
Contact vendor
|
| Deployment | Software solution, integrated into healthcare facility systems with advanced cardiology algorithms. |
| Compliance | |
| BAA Available | Yes AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
Yes AI-estimated Tempus ECG-AF received 510(k) clearance (K233549) from the U.S. Food and Drug Administration (FDA) on June 26, 2024. It is noted as the first FDA clearance for an AF indication in the 'cardiovascular machine learning-based notification software' category. |
| Integrations | |
| EHR | Not specified |
| Specialties | Cardiology, Geriatrics, Internal Medicine |
What the Web Says
Tempus ECG-AF is an AI-powered software designed to analyze 12-lead ECG recordings to predict the one-year risk of atrial fibrillation (AF) or flutter in patients aged 65 and older without a prior history of AF or certain other conditions. It received FDA clearance in 2024 and has undergone multi-site validation studies demonstrating its ability to consistently predict AF across varied clinical environments. The software aims to shift cardiac care towards earlier risk detection to minimize serious complications like stroke and heart failure.
Overall: MixedStrengths
- AI-enabled early risk detection of AF, even in ECGs interpreted as normal.
- FDA-cleared in 2024 for predicting one-year risk of AF or flutter.
- Validated in multi-center clinical studies across diverse environments.
- Can help clinicians identify hidden AF risks sooner, potentially reducing complications like stroke.
- Integrates with existing ECG platforms and EHRs.
- First FDA-cleared ECG-AI device in Tempus' cardiovascular diagnostic portfolio.
Limitations
- Not for use in patients with a history of AF (unless resolved after cardiac surgery within 30 days) or those with pacemakers/defibrillators.
- Results should be interpreted with other diagnostic information and not as the sole basis for diagnosis or treatment.
- Performance of repeated testing over time has not been evaluated and should not be used for patient monitoring.
- Tempus as a company has received mixed employee reviews, with some reporting disorganized management and poor work-life balance.
- Low customer satisfaction for Tempus products in general, based on a limited number of reviews.
Based on reviews from: Tempus.com, Investing.com, Heart Rhythm, Intellectia.AI, Cardiac Rhythm News, accessdata.fda.gov, Reddit, Business Wire, Stock Titan, PMC, Capterra, Indeed.com
Last updated: 2026-07-19
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