AgileMD receives US FDA clearance for eCART to predict in-hospital clinical deterioration across medical conditions

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AgileMD, Inc., an artificial intelligence (AI)-powered clinical decision support company, has announced that the US Food and Drug Administration (FDA) has granted 510(k) marketing clearance for its eCART Clinical Deterioration Suite.

eCART is a research-based, AI-driven software as a medical device (SaMD) that utilises a machine learning algorithm to continuously assess hospitalised patients’ risk of impending death or intensive care unit (ICU) transfer, assisting medical staff in swift and accurate recognition of patients requiring increased medical attention.

This clearance was based on clinical performance data in nearly two million hospitalisations from 21 hospitals, including an unprecedented level of real-world prospective data, to ensure consistent accuracy across geography, age, race, and top medical conditions.

eCART is the product of over a decade of research at the University of Chicago, US. The software is directly embedded into the electronic health record (EHR) and leverages up to 97 real-time variables, including labs, vital signs, and nursing assessments, to generate an eCART score and risk designation. From there, clinical staff are guided to embedded clinical pathways for care evaluation and management.