AgileMD, an AI-powered clinical decision support company, announced today that the FDA has granted 510(k) marketing clearance for its eCART Clinical Deterioration Suite. eCART is an AI-driven software as a medical device (SaMD) that uses a machine learning algorithm to continuously assess hospitalized 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 hospitalizations from 21 hospitals, including an unprecedented level of real-world prospective data, to ensure consistent accuracy across geography, age, race, and top medical conditions.
As an all-cause clinical deterioration prediction device, eCART captures risk across all ward patients, including those who are septic, allowing clinical teams to utilize a more streamlined approach to assessing the patients on their watch.
eCART is the product of over a decade of research at the University of Chicago. 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.
