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A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index
Andrew Frock1,2, Jeffrey T Robbins1,2, Francisco G Vital-Lopez1,2
1Department of Defense Biotechnology High Performance Computing Software Applications Institute, Defense Health Agency Research and Development, Medical Research and Development Command, Fort Detrick, MD.
NEJM AI
|March 16, 2026
Summary
Combat medics can now better identify trauma casualties at high risk for hemorrhage. The APPRAISE-HRI software, a novel artificial intelligence tool, received FDA clearance for assessing hemorrhage risk, improving battlefield triage and care.
Area of Science:
- Medical Technology
- Artificial Intelligence in Medicine
- Trauma Care
Background:
- Hemorrhage is a primary cause of preventable battlefield deaths.
- Combat medics currently lack decision support systems for hemorrhage risk stratification in trauma patients.
Purpose of the Study:
- To independently validate the Automated Processing of the Physiological Registry for Assessment of Injury Severity - Hemorrhage Risk Index (APPRAISE-HRI) software.
- To obtain U.S. Food and Drug Administration (FDA) clearance for APPRAISE-HRI as a medical device.
Main Methods:
- Collected vital sign and trauma registry data from 5895 trauma patients across eight medical centers.
- Utilized likelihood ratios to assess APPRAISE-HRI's ability to stratify hemorrhage risk.
- Defined study outcome as hemorrhagic injury, confirmed by documented injuries and blood transfusion.
Main Results:
- Hemorrhagic patients were 6.88 times more likely than controls to be classified at HRI level III (high risk).
- Hemorrhagic patients were 0.18 times as likely as controls to be at HRI level I (low risk).
- APPRAISE-HRI achieved FDA 510(k) clearance (K233249) as an AI-enabled Class II medical device.
Conclusions:
- APPRAISE-HRI effectively stratifies hemorrhage risk in trauma patients.
- This AI-powered tool is the first FDA-approved software for assessing combat-related hemorrhage risk.
- The device facilitates improved triage and identification of casualties requiring immediate attention and evacuation.
