Etiometry Receives a First-Ever FDA Clearance for Automating Hospital-Specific Cardiogenic Shock Classification and Tracking

BOSTON--(BUSINESS WIRE)--Etiometry, a leader in AI-driven clinical intelligence, today announced it has received FDA clearance (K254066) for the first-ever solution for automation of hospital-specific cardiogenic shock classification and tracking by directly utilizing data from physiologic monitoring, the Etiometry Cardiogenic Shock Tool.

Cardiogenic shock remains a critical challenge, with delayed identification contributing to poor outcomes and persistently high mortality rates, despite advances in care. Etiometry’s Cardiogenic Shock Tool addresses this gap by enabling hospital-wide surveillance using Society for Cardiovascular Angiography & Interventions (SCAI) guidelines and staging, while aligning with institutional protocols, equipping cardiogenic shock teams with the continuous, standardized situational awareness needed to coordinate care effectively across the enterprise.

The platform provides cardiac care teams with a continuous, consolidated view of hemodynamic and organ function status by integrating high-fidelity physiologic data with electronic health records (EHRs), alongside laboratory and device inputs. This enables clinicians to assess shock progression, evaluate therapeutic response and make informed decisions using standardized data and analytics. The solution supports shock classification and SCAI staging across the continuum of care, from the OR and ICU to step-down units and telemetry, enabling more coordinated management of cardiogenic shock across care teams and health systems.

Recent data show that 50% or more of cardiogenic shock cases go undocumented, even at advanced stages, delaying life-saving interventions and limiting hospitals’ ability to capture patient acuity for quality performance and reimbursement fully. Etiometry addresses this challenge by delivering real-time, automated, hospital-specific classification and longitudinal tracking of shock severity, facilitating earlier identification of deterioration and more complete, accurate documentation.

In addition to enhancing clinical decision-making, the Etiometry Platform has been associated with improved operational outcomes, including reduced length of stay, fewer ICU readmissions and shorter durations of critical therapies.¹

"This FDA clearance reinforces Etiometry's commitment to delivering a complete clinical decision support solution for cardiac care," said Shane Cooke, president and CEO of Etiometry. "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."

Etiometry continues to advance AI-driven clinical intelligence solutions that empower clinicians, improve hospital performance and support the delivery of high-quality, cost-effective care. For more information, visit www.etiometry.com.

Disclaimers:

• Adjunctive clinician-support only; not for alarm notification, active patient monitoring or sole-source clinical decision-making.
• The cleared update supports institution-defined cardiogenic shock classification within Etiometry’s existing Clinical Pathways framework, providing longitudinal stage visualization for clinician review.

About Etiometry

Founded in 2010, Etiometry offers an AI-driven clinical intelligence platform designed to help critical care clinicians make data-driven, proactive decisions. By leveraging advanced analytics and AI-powered insights, the company empowers care teams to detect subtle changes in patient conditions, prevent complications, and improve recovery times.

Etiometry has received 11 FDA clearances and is trusted by leading healthcare institutions worldwide, including top-ranked academic medical centers and pediatric hospitals. The company is committed to advancing patient safety, improving clinical efficiency, and lowering the cost of care through smarter data utilization. To learn more, visit www.etiometry.com.

¹ In observational studies at select sites, implementation was associated with reductions; results vary by site; not designed to prove causality.