First Automated Hospital-Specific Cardiogenic Shock Classification Tool for Critical Care Teams

Etiometry has received FDA clearance (K254066) for the Etiometry Cardiogenic Shock Tool: the first-ever automated solution for hospital-specific cardiogenic shock classification and tracking (aligned with each institution’s own protocols) using physiologic monitoring data. This is Etiometry’s 11th FDA clearance overall, and the only solution that automates SCAI staging directly from physiologic monitoring data.

For cardiac critical care teams, that means continuous, standardized situational awareness across the full care continuum, OR, ICU, step-down, and telemetry, without relying on manual documentation or retrospective chart review.

What the Cardiogenic Shock Tool Does

The Etiometry Cardiogenic Shock Tool integrates high-fidelity physiologic data with EHRs, laboratory values, and device inputs to give cardiac care teams a continuous, consolidated view of hemodynamic and organ function status. Using Society for Cardiovascular Angiography & Interventions (SCAI) guidelines and staging (aligned with each institution’s own protocols) it supports hospital-wide surveillance of shock progression, continuous stage tracking, and evaluation of therapeutic response.

Critically, it also automates documentation, supporting more accurate coding and reimbursement, an area where the gap between clinical reality and what gets captured has real financial consequences for health systems.

Why This Matters: The Limits of EHR-Based Shock Detection

EHR-based detection lags behind evolving physiology. High-frequency physiologic data that reflects a patient’s current hemodynamic state often goes uncaptured, and with it, the ability to classify and respond to shock progression in a timely way.

Recent data illustrates the scale of this gap: patients up-classified by Etiometry had 1.6× higher mortality and 1.9× higher readmission risk than EHR documentation alone would have indicated. Each additional hour of undetected hypotension increases mortality risk by approximately 11%. And even in the most severe cases , SCAI Stage E, EHR documentation captured only around 52% of patients.

More than 50% of cardiogenic shock cases go undocumented even at advanced stages. For high acuity monitoring teams, that’s not just a clinical gap, it’s a quality reporting and reimbursement gap.

This is where clinical intelligence software built around continuous physiologic data makes a meaningful difference.

Part of a Broader Clinical Intelligence Platform

This clearance adds a meaningful layer to Etiometry’s existing clinical intelligence platform, which already spans respiratory and hemodynamic trajectory tracking.

Shane Cooke, President and CEO of Etiometry, on the clearance:

“Cardiogenic shock classification adds a pivotal layer to our platform, giving care teams continuous visibility into shock progression alongside intelligent respiratory and hemodynamic trajectory tracking. Together, these capabilities provide clinicians with a more comprehensive and timely operational picture for managing some of the most complex patients they treat.”

In observational studies at select sites, implementation of the Etiometry Platform has been associated with reduced length of stay, fewer ICU readmissions, and shorter durations of critical therapies. Results vary by site and are not designed to prove causality.

The Etiometry Cardiogenic Shock Tool supports institution-defined cardiogenic shock classification within Etiometry’s existing Clinical Pathways framework, providing longitudinal stage visualization for clinician review. It is intended as adjunctive clinician support.

In observational studies at select sites, implementation was associated with reductions; results vary by site; not designed to prove causality.

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