Tempus ECG-Low EF

JSON twin: https://www.healthaidb.com/software/tempus-ecg-low-ef.json

Company Name

Tempus

Product URL

https://www.tempus.com/cardiology/ecg-ai/

Company URL

https://www.tempus.com

Categories

• clinical Care
• diagnostic Support
• cardiology
• Clinical
• Diagnostic

Summary

Tempus ECG-Low EF is an AI-powered software that analyzes 12-lead ECG recordings to identify patients at risk for low left ventricular ejection fraction (LVEF), aiding early detection of heart failure.

Description

Tempus ECG-Low EF utilizes machine learning algorithms to process resting, non-ambulatory 12-lead ECG recordings from patients aged 40 and older, detecting signs associated with LVEF ≤40%. It integrates with existing ECG platforms and EHRs, providing a binary output to assist clinicians in early identification of heart failure risk. The software is not intended as a standalone diagnostic tool and should be used in conjunction with other clinical information. It received FDA 510(k) clearance on July 16, 2025.

Api Available

unknown

Certifications

• FDA 510(k) clearance

Company Founding

2015

Company Offices

• United States

Compliance

• HIPAA
• FDA 510(k) clearance

Customers

Data Residency

US

Data Standards

• ECG data standards

Deployment Model

• SaaS

Features

• AI-powered analysis of 12-lead ECG recordings
• Detection of low left ventricular ejection fraction (LVEF ≤40%)
• Integration with existing ECG platforms and EHRs
• Patient filtering based on clinical data
• Identification of patients at risk for heart failure
• Non-invasive assessment of cardiac function
• Scalable deployment within clinical workflows
• Support for clinicians in early detection of cardiovascular conditions
• FDA-cleared device for clinical use
• Intended for patients aged 40 and older
• Not intended as a stand-alone diagnostic tool
• Positive results suggest need for further clinical evaluation
• Not for use on ECGs with paced rhythms
• Not intended for patient monitoring
• Provides binary output for interpretation
• Results should be interpreted with other diagnostic information
• Supports clinicians in identifying patients at risk for serious cardiovascular conditions
• Designed to work with existing ECG platforms
• Provides clinicians with tools to detect low LVEF at scale
• Reflects Tempus' commitment to advancing AI-driven cardiology

Id

SW0203

Integration Partners

Integrations

• ECG platforms
• EHRs

Languages Supported

• English

Last Updated

2025-10-11

License

Commercial

Market Segment

• Enterprise
• SMB

Optional Modules

Os Platforms

• Web

Pricing Details

Contact vendor for pricing information.

Pricing Model

Subscription

Privacy Features

• Data anonymization
• Patient consent management

Product Code

SW0203

Product Name

Tempus ECG-Low EF

Ratings

Regions Available

• United States

Related Urls

• https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices

Release Year

Security Features

• Data encryption
• Access controls
• Audit logs

Specialties

• Cardiology

Support Channels

System Requirements

Target Users

• Clinicians
• Cardiologists
• Healthcare Providers

Training Options

Type

product

User Reviews

Version

1.0

Alternatives

See related products

Canonical JSON

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  "product_name": "Tempus ECG-Low EF",
  "company_name": "Tempus",
  "product_url": "https://www.tempus.com/cardiology/ecg-ai/",
  "company_url": "https://www.tempus.com",
  "related_urls": [
    "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices"
  ],
  "product_code": "SW0203",
  "summary": "Tempus ECG-Low EF is an AI-powered software that analyzes 12-lead ECG recordings to identify patients at risk for low left ventricular ejection fraction (LVEF), aiding early detection of heart failure.",
  "description": "Tempus ECG-Low EF utilizes machine learning algorithms to process resting, non-ambulatory 12-lead ECG recordings from patients aged 40 and older, detecting signs associated with LVEF ≤40%. It integrates with existing ECG platforms and EHRs, providing a binary output to assist clinicians in early identification of heart failure risk. The software is not intended as a standalone diagnostic tool and should be used in conjunction with other clinical information. It received FDA 510(k) clearance on July 16, 2025.",
  "categories": [
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  "market_segment": [
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    "SMB"
  ],
  "target_users": [
    "Clinicians",
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    "Healthcare Providers"
  ],
  "specialties": [
    "Cardiology"
  ],
  "regions_available": [
    "United States"
  ],
  "languages_supported": [
    "English"
  ],
  "pricing_model": "Subscription",
  "pricing_details": "Contact vendor for pricing information.",
  "license": "Commercial",
  "company_offices": [
    "United States"
  ],
  "company_founding": "2015",
  "deployment_model": [
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  "os_platforms": [
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  "features": [
    "AI-powered analysis of 12-lead ECG recordings",
    "Detection of low left ventricular ejection fraction (LVEF ≤40%)",
    "Integration with existing ECG platforms and EHRs",
    "Patient filtering based on clinical data",
    "Identification of patients at risk for heart failure",
    "Non-invasive assessment of cardiac function",
    "Scalable deployment within clinical workflows",
    "Support for clinicians in early detection of cardiovascular conditions",
    "FDA-cleared device for clinical use",
    "Intended for patients aged 40 and older",
    "Not intended as a stand-alone diagnostic tool",
    "Positive results suggest need for further clinical evaluation",
    "Not for use on ECGs with paced rhythms",
    "Not intended for patient monitoring",
    "Provides binary output for interpretation",
    "Results should be interpreted with other diagnostic information",
    "Supports clinicians in identifying patients at risk for serious cardiovascular conditions",
    "Designed to work with existing ECG platforms",
    "Provides clinicians with tools to detect low LVEF at scale",
    "Reflects Tempus' commitment to advancing AI-driven cardiology"
  ],
  "optional_modules": [],
  "integrations": [
    "ECG platforms",
    "EHRs"
  ],
  "data_standards": [
    "ECG data standards"
  ],
  "api_available": "unknown",
  "system_requirements": "",
  "compliance": [
    "HIPAA",
    "FDA 510(k) clearance"
  ],
  "certifications": [
    "FDA 510(k) clearance"
  ],
  "security_features": [
    "Data encryption",
    "Access controls",
    "Audit logs"
  ],
  "privacy_features": [
    "Data anonymization",
    "Patient consent management"
  ],
  "data_residency": "US",
  "customers": [],
  "user_reviews": [],
  "ratings": [],
  "support_channels": [],
  "training_options": [],
  "release_year": "",
  "integration_partners": [],
  "id": "SW0203",
  "slug": "tempus-ecg-low-ef",
  "type": "product",
  "version": "1.0",
  "last_updated": "2025-10-11",
  "links_json": {
    "self": "https://www.healthaidb.com/software/tempus-ecg-low-ef.json"
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}