APPRAISE-HRI

by The Surgeon General, Department of the Army (TSG-DA)  · Based in United States → — AI-enabled Hemorrhage Risk Stratification for Military Trauma Care
Critical Care Emergency Medicine General Surgery
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Not applicable for direct purchase; licensed for military applications.
Regulatory Status Disclosed

Overview

APPRAISE-HRI (Automated Processing of the Physiological Registry for Assessment of Injury Severity-Hemorrhage Risk Index) is an artificial intelligence-enabled mobile health application developed by the U.S. Army Medical Research and Development Command’s (USAMRDC) Biotechnology High Performance Computing Software Applications Institute (BHSAI). It is designed for military healthcare providers to screen U.S. Service Members for hemorrhage risk after a physically traumatic event.

The Android application collects heart rate, systolic blood pressure, and diastolic blood pressure data from an external vital-sign monitor (e.g., ZOLL Propaq M) via Bluetooth. It then analyzes these patterns using AI to stratify the patient’s hemorrhage risk into three levels: Low (I), Average (II), or High (III).

APPRAISE-HRI is intended to provide situational awareness and inform the clinical management of potentially hemorrhagic casualties by identifying those at the greatest risk, thereby assisting medics in triaging casualties in prolonged field care scenarios with limited resources. It is not intended to diagnose or direct treatment.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • AI-powered hemorrhage risk stratification
  • Analyzes heart rate, systolic blood pressure, and diastolic blood pressure
  • Provides three risk levels: Low (I), Average (II), and High (III)
  • Mobile health application (Android)
  • Connects via Bluetooth to external vital-sign monitors (e.g., ZOLL Propaq M)
  • Offers situational awareness for clinical management
  • Rapid assessment (within 10 minutes)
  • Not for diagnosis or direct treatment

Use Cases

  • Triage of combat casualties at the point of injury
  • Screening U.S. Service Members for hemorrhage risk after traumatic events
  • Stratifying casualties for immediate attention and emergency evacuation
  • Informing clinical management in prolonged field care scenarios
  • Assisting medics with limited resources

What Physicians Need to Know

Key Capabilities
Screens U.S. Service Members for hemorrhage risk after traumatic events and stratifies them into low (I), average (II), or high (III) risk levels. It analyzes heart rate and blood pressure data from external vital-sign monitors, providing an output every minute.
Clinical Utility
Aids military healthcare providers in triaging casualties for immediate attention and evacuation, optimizing decision-making in resource-limited, prolonged field care scenarios. It improves situational awareness by identifying those at greatest risk of hemorrhage, which is a leading cause of preventable death on the battlefield.
Integration Options
Operates as an Android smartphone application that connects via Bluetooth to compatible external vital-sign monitors, such as the ZOLL Propaq M, to continuously pull and process data. The technology is being actively licensed to commercial partners for broader integration.
Compliance Status
Received FDA 510(k) clearance as a Class II Software as a Medical Device (SaMD) in 2024, making it the first AI-enabled SaMD from the DoD for assessing hemorrhage risk in trauma patients. It conforms to ISO 14971:2019 and IEC 62304:2016 standards and underwent cybersecurity testing.
Pricing Model
The U.S. Army holds three U.S. patents for APPRAISE-HRI and is actively seeking to license the technology to interested commercial partners. Specific end-user pricing models are not publicly available as it is currently in the licensing phase.
User Experience
Usability tests with DoD medics indicated that the device was easy to use and helpful, with 93.3% of participants correctly interpreting the outputs. The risk score is designed for easy interpretation, and tailored training programs are available for users.
Support Quality
Developed by the U.S. Army Medical Research and Development Command (MRDC)'s BHSAI with robust regulatory support from MRDC's Office of Regulated Activities and RQMIS throughout its FDA clearance process. Future support will likely be provided by commercial licensing partners.
Implementation Complexity
Requires an Android smartphone and a compatible vital-sign monitor. Implementation involves user training, which is expected for intended users (e.g., Army medics). The development adhered to a Quality Management System for design control and risk management.
Evidence Base
Developed over two decades, trained on 1,659 trauma patients (540 hours of data), and independently validated with vital-sign data from nearly 6,000 additional trauma patients across nine sites. Clinical studies demonstrated its effectiveness in stratifying hemorrhage risk, with results published in NEJM AI.
Physician Tip

APPRAISE-HRI is a valuable AI-enabled tool for early hemorrhage risk assessment in trauma patients, particularly in austere or resource-limited environments. Remember it's a risk stratification tool to enhance situational awareness and inform clinical management, not for definitive diagnosis or treatment direction. Familiarize yourself with the three risk levels (Low, Average, High) and integrate its output with your clinical judgment and other vital sign parameters. Its origin in military medicine suggests robust design for high-stress scenarios, with potential applicability in civilian mass casualty events.

Currently, APPRAISE-HRI integrates with vital-sign monitors like the ZOLL Propaq M via Bluetooth to an Android smartphone application. As the U.S. Army is seeking commercial licensing partners, future integrations may expand to other medical devices and broader healthcare IT systems, potentially contributing to a more comprehensive 'Common Operating Picture' in both military and civilian trauma care settings.

Details

Category Triage & ER/ICU AI
Pricing Not applicable for direct purchase; licensed for military applications. — N/A
DeploymentMobile application (Android)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

Received FDA 510(k) clearance (K233249) on April 5, 2024, as the first AI-enabled software from the DoD for assessing hemorrhage risk in trauma patients. It is classified as a Class II device (21 CFR 870.2220) for Adjunctive Hemodynamic Indicator With Decision Point for Military Use.
Integrations
EHR Not specified
Specialties Critical Care, Emergency Medicine, General Surgery

What the Web Says

APPRAISE-HRI is an AI-powered software designed to assess hemorrhage risk in trauma patients using vital sign data. It has received FDA clearance, indicating its effectiveness as a tool to aid in discriminating hemorrhage risk. The system can stratify patients into low, average, and high-risk categories within 10 minutes, which is particularly beneficial in prolonged field care scenarios with limited resources.

Overall: Positive

Strengths

  • FDA-cleared as a useful tool for discriminating hemorrhage risk.
  • Highly effective in classifying patients into three risk categories.
  • Can stratify hemorrhage risk within 10 minutes.
  • Aids medics in triaging casualties in resource-limited scenarios.
  • Uses routinely measured vital signs (heart rate, systolic and diastolic blood pressure).
  • Validated in independent clinical utility studies with large patient datasets.

Limitations

  • No specific cons were found in the provided search results regarding the APPRAISE-HRI software itself from the perspective of physicians, healthcare IT, or tech reviewers.
  • Some general challenges in the FDA clearance process for AI-enabled software were noted, focusing on clinical benefit and patient risk over algorithm development.

Based on reviews from: U.S. Army, PubMed, PMC, Capterra, G2

Last updated: 2026-07-20

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Press & Coverage

HJF
HJF Supported Program Receives FDA Clearance for First AI Software for Hemorrhage Triage
The U.S. FDA has cleared APPRAISE-HRI, an AI application for hemorrhage triage of combat casualties, developed by the U.S. Army Medical Research and Development Command (MRDC)'s BHSAI and HJF Research Scientists. This first-of-its-kind software helps medics automatically screen and stratify Service members for hemorrhage risk after traumatic events.
2024-04
U.S. Army
FDA clears first AI software for hemorrhage triage of combat casualties | Article - U.S. Army
The FDA has cleared APPRAISE-HRI, an AI-powered smartphone application developed by the U.S. Army Medical Research and Development Command, which uses vital-sign data to assess hemorrhage risk in trauma patients. This marks a significant milestone, allowing for military licensing to potentially save lives by rapidly identifying those at risk of massive blood loss.
2024-04
U.S. Army Medical Research & Development Command
APPRAISE-HRI, an artificial intelligence enabled decision-support application for military health care providers to stratify hemorrhage risk of US Service Members after a traumatic event, cleared by the U.S. FDA
The U.S. Army Medical Research and Development Command's Biotechnology High Performance Computing Software Applications Institute obtained FDA clearance for APPRAISE-HRI, an AI-enabled mobile health application. It is designed to help military healthcare providers screen U.S. Service Members for hemorrhage risk and prioritize immediate attention and evacuation.
2024-04
U.S. Army Medical Research and Development Command
FDA Clears First AI Software for Hemorrhage Triage of Combat Casualties
The FDA has cleared APPRAISE-HRI, the first AI software for hemorrhage triage of combat casualties, developed by the U.S. Army Medical Research and Development Command. This system can stratify hemorrhage risk within 10 minutes, significantly aiding medics in prolonged field care scenarios.
2026-01
Defense Health Agency Research & Development
APPRAISE Lands Publication in New England's Top Medical Journal
Dr. Jaques Reifman's case report on APPRAISE-HRI, an FDA-cleared AI-driven tool for hemorrhage triage, was published in the November 2025 issue of the New England Journal of Medicine-Artificial Intelligence. This publication highlights the system's scientific foundation and potential for broader adoption in clinical practice.
2026-01
PubMed Central (PMC)
A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma - PMC
This case study details the FDA 510(k) clearance of APPRAISE-HRI as a Class II device in 2024, making it the first software as a medical device approved for assessing hemorrhage risk in trauma patients. The software helps military healthcare providers triage service members by stratifying hemorrhage risk.
2025-10
Clinical Decision Technology Laboratory
Clinical Decision Technology Laboratory
The Clinical Decision Technology Laboratory co-authored a publication in NEJM AI detailing the development and FDA clearance of APPRAISE-HRI, an AI-enabled clinical decision support tool for assessing hemorrhage risk in trauma patients. This represents a significant milestone as one of the first FDA-cleared AI software systems for real-time risk stratification in acute care.
2026-05
PubMed
APPRAISE-HRI: AN ARTIFICIAL INTELLIGENCE ALGORITHM FOR TRIAGE OF HEMORRHAGE CASUALTIES - PubMed
This study, published in August 2023, describes the development of the APPRAISE-HRI algorithm, which uses routinely measured vital signs to identify trauma patients at the greatest risk of hemorrhage. The algorithm stratifies hemorrhage risk into low, average, and high categories, providing a new capability for medics.
2023-08

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Frequently Asked Questions

APPRAISE-HRI is a mobile health application that receives continuous heart rate and blood pressure data from a standard vital-sign monitor via Bluetooth. It then uses an AI algorithm to analyze these patterns and stratify a patient's hemorrhage risk into low, average, or high levels within minutes. This provides healthcare providers with a rapid risk assessment to inform triage and clinical management decisions.
APPRAISE-HRI primarily uses three routinely measured vital signs: heart rate (HR), systolic blood pressure (SBP), and diastolic blood pressure (DBP). The application continuously pulls and processes this data, generating an updated hemorrhage risk level every minute, allowing for rapid situational awareness in trauma scenarios.
Yes, APPRAISE-HRI has obtained FDA 510(k) clearance as a Class II Software as a Medical Device (SaMD). This clearance signifies that the FDA has determined the device to be safe and effective for its intended use as a risk assessment tool, though it is not intended to diagnose or direct treatment.
APPRAISE-HRI is intended as a risk assessment tool to inform clinical management, not to diagnose or direct treatment. It was validated on adult trauma patients (18-90 years) and its performance was consistent across subgroups, except for ruling in hemorrhage patients with penetrating injury due to low numbers in the study population.
Traditionally, hemorrhage risk assessment relies on physician evaluation and established clinical protocols, often activated once a patient reaches a hospital. APPRAISE-HRI offers an automated, AI-driven approach to stratify risk using routine vital signs, which is particularly beneficial in prehospital or resource-limited settings for rapid identification of high-risk patients.
While specific pricing for civilian healthcare systems is not detailed, the U.S. Army Medical Research and Development Command's Medical Technology Transfer Office is actively seeking commercial partners to license APPRAISE-HRI. This indicates that commercial availability and associated costs would be established through these future licensing agreements.

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Suggest an Edit → | Last Verified: 2026-04-20 | First Added: 2026-04-20
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