eCARTv5 Clinical Deterioration Suite (“eCART”)

by AgileMD  · Based in United States → — FDA Cleared Clinical Deterioration Early Warning & Workflow
Critical Care Emergency Medicine Hospital Medicine
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Overview

The eCARTv5 Clinical Deterioration Suite (“eCART”) by AgileMD is an AI-powered Software as a Medical Device (SaMD) designed to continuously assess the risk of impending clinical deterioration in hospitalized adult ward patients, specifically predicting death or Intensive Care Unit (ICU) transfer. Integrating directly into the Electronic Health Record (EHR) system, eCART leverages up to 97 real-time variables, including vital signs, laboratory data, and nursing assessments, to generate an eCART score and risk designation. This early warning system aims to maximize early identification of at-risk patients, minimize false alarms, and decrease clinician workload. Beyond prediction, the suite includes embedded clinical pathways to guide medical staff in the evaluation and management of patient care, ensuring timely and appropriate escalation. Developed from over a decade of research, eCART is a cloud-based platform that supports standardized workflows and provides robust reporting and benchmarking capabilities to drive quality improvement.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered clinical deterioration prediction
  • Continuous patient risk assessment (death or ICU transfer)
  • EHR integration with real-time data (up to 97 variables)
  • Embedded clinical pathways for care guidance
  • Early warning system (alerts hours before critical illness)
  • Risk stratification (eCART score and risk designation)
  • Minimizes false alarms and clinician workload
  • Reporting and benchmarking capabilities
  • Customizable protocols and pathways
  • Cloud-based SaaS platform

Use Cases

  • Early identification of at-risk hospitalized patients
  • Preventing failure to rescue
  • Improving timely ICU transfers
  • Reducing clinical variation and standardizing care
  • Optimizing resource utilization
  • Guiding medical staff in evaluating and managing patient care

What Physicians Need to Know

Evidence Base
eCARTv5 is built upon over a decade of research from the University of Chicago. It utilizes a gradient-boosted machine model and analyzes up to 97 real-time variables from electronic health records (EHR), including laboratory results, vital signs, and nursing assessments. The model predicts the likelihood of ICU transfer or death within 24 hours.
Clinical Validation Studies
eCARTv5 has undergone extensive multicenter retrospective and prospective observational studies. The development cohort included over 900,000 admissions, the retrospective validation cohort included nearly 1.8 million admissions, and the prospective validation cohort included over 200,000 admissions across multiple health systems and 21 hospitals. In retrospective validation, eCARTv5 demonstrated superior performance with an AUROC of 0.834, outperforming eCARTv2 (0.775), NEWS (0.766), and MEWS (0.704). Its performance remained high across diverse patient demographics and clinical conditions. The FDA clearance for eCARTv5 was based on this clinical performance data.
Alert Fatigue Management
eCARTv5 was designed to minimize false alarms and decrease clinician workload. One study indicated that eCARTv5 would have caught over 300 more deteriorating patients than the Epic Deterioration Index while alerting on nearly 48,000 fewer.
Clinical Workflow Integration
eCARTv5 is a cloud-based software device that integrates directly into the electronic health record (EHR) system. It provides an eCART score and risk designation, and then guides clinical staff to embedded clinical pathways for evaluation and management of patient care. The system is designed to provide a streamlined approach to patient assessment.
Decision Audit Trail
Embedded workflow features allow users to acknowledge risk predictions and record next steps for medical management based on their independent clinical judgment.
Physician Tip

eCARTv5 is an AI-powered tool that integrates into the EHR to provide real-time risk assessment for clinical deterioration in adult ward patients. It is designed to aid in early identification of at-risk patients and guide clinical teams to appropriate pathways, potentially reducing delays in care escalation. While it provides valuable information, it serves as a clinical decision support device and does not replace standard of care or clinical judgment. Physicians should utilize the tool's insights in conjunction with their expertise and patient-specific clinical context.

eCARTv5 is designed for direct integration into Electronic Health Record (EHR) systems. It requires an EHR connection and data interfaces to transmit necessary patient data for its operation. The software leverages real-time data from the EHR, including vital signs, laboratory results, and nursing assessments, to generate risk scores and guide clinical pathways.

Details

Category Clinical Decision Support & Reference, Triage & ER/ICU AI
Pricing Contact vendor
DeploymentSaaS (Software as a Service).
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, Hospital Medicine

What the Web Says

eCARTv5 Clinical Deterioration Suite is an AI-powered software designed to identify early clinical deterioration in hospitalized ward patients. It integrates with Electronic Health Records (EHR) to analyze real-time patient data, including vital signs, lab results, and demographics, to predict the risk of ICU transfer or death within 24 hours. The software has undergone extensive validation and has received FDA 510(k) marketing clearance.

Overall: Positive

Strengths

  • Accurately identifies early clinical deterioration, outperforming other early warning scores like NEWS and MEWS.
  • Provides alerts significantly earlier than traditional methods, with a median of 5 hours in advance of clinical deterioration.
  • Validated through extensive clinical performance data from nearly two million hospitalizations across multiple hospitals.
  • Integrates directly into Electronic Health Records (EHR) for continuous, real-time patient assessment.
  • Reduces clinician workload and minimizes false alarms.
  • FDA 510(k) marketing clearance for use in identifying deterioration in hospitalized ward patients.

Limitations

No significant limitations found in public reviews. Consider checking vendor documentation or requesting a demo for a thorough evaluation.

Based on reviews from: researchgate.net, physicianaitools.com, nih.gov, medrxiv.org, healthaidb.com, withpower.com, innolitics.com, fda.gov, healthcarediscovery.ai, reaganudall.org

Last updated: 2026-10-28

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Press & Coverage

U.S. Food and Drug Administration
510(k) Summary: eCARTv5 Clinical Deterioration Suite (“eCART”)
The FDA cleared the eCARTv5 Clinical Deterioration Suite on June 21, 2024. This cloud-based software device is integrated into the electronic health record to anticipate clinical deterioration in adult ward patients, predicting outcomes such as death or ICU transfer.
2024-06
Orthogonal
SaMD Cleared by the FDA: The Ultimate Running List
AgileMD's eCARTv5 Clinical Deterioration Suite (“eCART”) was cleared by the FDA on June 21, 2024, and is included in a comprehensive list of FDA-cleared Software as a Medical Devices (SaMD).
2024-10
JAMA Network Open
Early Warning Scores With and Without Artificial Intelligence
This article, published in October 2024, discusses early warning scores, including those utilizing artificial intelligence, and is featured on AgileMD's publications page.
2024-10
Resuscitation
A novel structured debriefing program for consensus determinations of in-hospital cardiac arrest predictability and preventability
Published in 2024, this article explores a structured debriefing program for determining the predictability and preventability of in-hospital cardiac arrest.
2024
Critical Care Explorations
Causes, Diagnostic Testing, and Treatments Related to Clinical Deterioration Events Among High-Risk Ward Patients
This 2024 publication investigates the causes, diagnostic testing, and treatments associated with clinical deterioration events in high-risk ward patients.
2024
physicianaitools.com
eCARTv5 Clinical Deterioration Suite (“eCART”) — AI-powered clinical decision support for better healthcare outcomes and efficiency
The eCARTv5 Clinical Deterioration Suite by AgileMD is highlighted as an AI-powered Software as a Medical Device (SaMD) designed to improve healthcare outcomes and efficiency.
2026-04
Critical Care Explorations
Multicenter Development and Prospective Validation of eCARTv5: A Gradient Boosted Machine Learning Early Warning Score
This peer-reviewed article, anticipated for April 2025, details the multicenter development and prospective validation of eCARTv5, a machine learning early warning score.
2025-04
American Thoracic Society, American Journal of Respiratory and Critical Care Medicine
Infection Specific Versus General Early Warning Scores for Predicting Sepsis on a Medical-Surgical Ward: A Multicenter Analysis
This article, expected in 2025, presents a multicenter analysis comparing infection-specific versus general early warning scores for predicting sepsis on a medical-surgical ward.
2025

Videos

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Frequently Asked Questions

eCARTv5 is a cloud-based software device that integrates directly into Electronic Health Record (EHR) systems. It continuously analyzes real-time patient data, such as vital signs, lab results, and demographics, to identify hospitalized adult ward patients at risk of clinical deterioration, specifically predicting imminent death or the need for ICU transfer. The system then directs clinical teams to standardized guidance for next steps in care for elevated-risk patients.
eCARTv5 is FDA 510(k) cleared as a Class II medical device and is HIPAA compliant. It has undergone extensive validation, including a multicenter study comparing it to six other early warning scores, where it demonstrated superior performance in identifying clinical deterioration. The model was developed using data from over 900,000 admissions and validated retrospectively on over 1.7 million admissions and prospectively on over 200,000 admissions across multiple health systems.
While eCARTv5 shows high accuracy, its gradient-boosted machine learning model is complex and can be difficult to interpret, suggesting a need for explainable AI approaches to provide clinicians with insights into the variables driving a patient's risk. Additionally, eCART provides supplementary information and is not intended to replace standard clinical judgment or care. The device calculates risk only from validated EHR data, such as vital signs confirmed by a registered nurse, and does not use unvalidated streaming data from monitors.
eCARTv5 has demonstrated superior performance compared to other AI and non-AI early warning scores. In a study comparing six early warning scores, eCARTv5 had the highest area under the receiver operating characteristic curve (AUROC) of 0.895, outperforming the National Early Warning Score (NEWS) (AUROC 0.831) and the Epic Deterioration Index (AUROC 0.808). It identified more deteriorating patients with fewer false alarms and provided earlier alerts, with a median of 5 hours advance notice at the high-risk threshold.
The pricing model for eCARTv5 is not publicly available. For specific pricing information, it is recommended to contact AgileMD directly.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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