AgileMD, Inc., an AI-powered clinical decision support company, has received 501(k) marketing clearance from the FDA for its eCART Clinical Deterioration Suite – a research-based, AI-driven software as a medical device (SaMD) that uses machine learning to continuously assess hospitalized patients’ risk of impending death or ICU transfer.
The clearance was based on clinical performance data in nearly two million hospitalizations from 21 hospitals, including real-world prospective data, to ensure consistent accuracy across geography, age, race and top medical conditions, including COPD.
Approximately 10% of hospitalized patients deteriorate during their hospital stay and while sepsis is the leading cause of clinical deterioration, more than half decline for other reasons. The eCART system captures risk across all ward patients, including those who are septic, allowing clinical teams a streamlined approach to assessing the patients on their watch.
“eCART was designed to maximize early identification of at-risk patients, minimize false alarms and decrease clinician workload, rather than add to it,” said Dana Edelson, MD, chief medical officer and co-founder of AgileMD.
According to AgileMD, the eCART suite was developed for more than a decade by researchers at the University of Chicago. It is directly embedded into the electronic health record and leverages up to 97 real-time variables including labs, vital signs and nursing assessments to generate an eCART score and risk designation.
