Summary: AgileMD announced that the FDA has granted 510(k) marketing clearance for its eCART Clinical Deterioration Suite, an AI-powered software designed to assess hospitalized patients’ risk of death or ICU transfer. The software leverages real-world clinical performance data to ensure accuracy across various patient demographics and medical conditions.

Key Takeaways:

  • FDA Clearance: AgileMD’s eCART Suite has been approved by the FDA, ensuring its reliability and safety for clinical use in predicting patient deterioration.
  • Real-World Data: The clearance was based on extensive data from nearly two million hospitalizations, demonstrating the software’s consistent accuracy and effectiveness across diverse patient populations.

AgileMD, Inc., an AI-powered clinical decision support company, announced that the U.S. FDA has granted 510(k) marketing clearance for its eCART Clinical Deterioration Suite.

FDA Clearance for eCART Clinical Deterioration Suite

eCART is a research-based, AI-driven software as a medical device (SaMD) that utilizes 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.

All-Cause Clinical Deterioration Prediction

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 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.”

Decade of Research

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.

“This landmark clearance delivers on the need and the importance of real-world clinical performance data,” said 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.”