Etiometry Receives First FDA Clearance for Automated Hospital-Specific Cardiogenic Shock Classification Tool
Etiometry, a provider of AI-driven clinical intelligence solutions, has received U.S. Food and Drug Administration (FDA) clearance (K254066) for its Cardiogenic Shock Tool, the first system authorised to automate hospital-specific cardiogenic shock classification and tracking using physiologic monitoring data.
The tool applies Society for Cardiovascular Angiography & Interventions (SCAI) guidelines to enable standardised classification and staging of cardiogenic shock across care settings.
It integrates high-fidelity physiologic monitoring with electronic health records, laboratory results, and device data to provide continuous assessment of haemodynamic and organ function status.
Designed for use across operating rooms, intensive care units, step-down units, and telemetry wards, the system supports coordinated care by delivering real-time insights into shock progression and therapeutic response.
It also enables longitudinal tracking of severity, improving situational awareness for multidisciplinary cardiac care teams.
Cardiogenic shock remains associated with high mortality, partly due to delayed recognition and under-documentation, with studies indicating that over half of cases may go unrecorded even at advanced stages.
Etiometry’s solution addresses this gap by automating classification and supporting more complete clinical documentation.
