Clinical decision support company AgileMD has obtained the US Food and Drug Administration (FDA) 510(k) marketing clearance for its eCART Clinical Deterioration Suite.
Powered by artificial intelligence (AI), the research-based eCART is a software as a medical device (SaMD) designed to predict in-hospital clinical deterioration across medical conditions.
It employs a machine learning algorithm to monitor hospitalised patients continuously, evaluating their risk of imminent death or transfer to the intensive care unit (ICU).
According to AgileMD, the technology aids healthcare professionals in promptly and accurately identifying patients who need increased medical attention.
eCART serves as an all-cause clinical deterioration prediction tool, capturing risk assessment for all ward patients, including those with sepsis. This allows clinical teams to use a more efficient approach in monitoring patients under their watch.
The FDA clearance was based on clinical performance data gathered from nearly two million hospitalisations across 21 hospitals.
The extensive dataset, comprising real-world prospective data, is said to guarantee consistent accuracy across geography, age, race, and prevalent medical conditions.
Additionally, the company said that the clinical deterioration suite successfully identified hospitalised high-risk patients in clinical trials for a variety of illnesses. These were for conditions such as heart failure, sepsis, and chronic obstructive pulmonary disease.
AgileMD chief medical officer and co-founder Dana Edelson said: “eCART was designed to maximise early identification of at-risk patients, minimise false alarms and decrease clinician workload, rather than add to it.
“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.”
According to the clinical decision support firm, eCART is the result of more than 10 years of research conducted at the University of Chicago.
The software integrates directly into the electronic health record (EHR) system and utilises up to 97 real-time variables to generate an eCart score and risk designation. These variables include laboratories, vital signs, and nursing assessments.
Based on the eCart score and risk designation, clinical staff are directed to embedded clinical pathways designed for the evaluation and management of patient care.
AgileMD was founded at the University of Chicago. In 2021, the company received a $2m Phase 2 National Institutes of Health (NIH) Small Business Innovation Research (SBIR) grant to develop the latest version of eCART.
