Sam Brusco, Associate Editor06.25.24
AgileMD, an artificial intelligence (AI)-powered clinical decision support company, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance for its eCart clinical deterioration suite.
eCart is a research-based, AI-driven software as a medical device (SaMD) that uses a machine learning algorithm to continuously evaluate hospitalized patients’ risk of impending death or intensive care unit (ICU) transfer. It can help medical staff quickly and accurately recognize patients needing increased medical attention.
The all-cause clinical deterioration prediction device eCare captures risk across all ward patients, including those who are septic. This way, according to AgileMD, clinical teams can employ a more streamlined approach to assessing patients on their watch.
The product of over a decade’s research at the University of Chicago, the software is embedded into the electronic health record (EHR) and leverages up to 97 variables to generate an eCart score and risk designation. These variables include labs, vital signs, and nursing assessments. From there, staff are guided to embedded clinical pathways to evaluate and manage care.
The FDA clearance was based on clinical performance data in almost two million hospitalizations from 21 hospitals. Agile MD said this includes an unprecedented level of real-world prospective data to ensure accuracy across geography, age, race, and top medical conditions.
“eCART was designed to maximize early identification of at-risk patients, minimize false alarms and decrease clinician workload, rather than add to it," said Dr. Dana Edelson, chief medical officer and co-founder of AgileMD. “We do that by marrying a best-in-class analytic with a highly intuitive user interface and well-tested clinical workflow, giving front line clinical teams the confidence and ability to escalate care when appropriate.”
“This landmark clearance delivers on the need and the importance of real-world clinical performance data,” added Borna Safabakhsh, AgileMD’s CEO and co-founder. “We believe that should be the standard for all AI-powered clinical models to ensure trust and safety.”
eCart is a research-based, AI-driven software as a medical device (SaMD) that uses a machine learning algorithm to continuously evaluate hospitalized patients’ risk of impending death or intensive care unit (ICU) transfer. It can help medical staff quickly and accurately recognize patients needing increased medical attention.
The all-cause clinical deterioration prediction device eCare captures risk across all ward patients, including those who are septic. This way, according to AgileMD, clinical teams can employ a more streamlined approach to assessing patients on their watch.
The product of over a decade’s research at the University of Chicago, the software is embedded into the electronic health record (EHR) and leverages up to 97 variables to generate an eCart score and risk designation. These variables include labs, vital signs, and nursing assessments. From there, staff are guided to embedded clinical pathways to evaluate and manage care.
The FDA clearance was based on clinical performance data in almost two million hospitalizations from 21 hospitals. Agile MD said this includes an unprecedented level of real-world prospective data to ensure accuracy across geography, age, race, and top medical conditions.
“eCART was designed to maximize early identification of at-risk patients, minimize false alarms and decrease clinician workload, rather than add to it," said Dr. Dana Edelson, chief medical officer and co-founder of AgileMD. “We do that by marrying a best-in-class analytic with a highly intuitive user interface and well-tested clinical workflow, giving front line clinical teams the confidence and ability to escalate care when appropriate.”
“This landmark clearance delivers on the need and the importance of real-world clinical performance data,” added Borna Safabakhsh, AgileMD’s CEO and co-founder. “We believe that should be the standard for all AI-powered clinical models to ensure trust and safety.”