FDA approves CLEW Medical’s new Artificial Intelligence ICU solution

CLEW Medical recently made an announcement stating that FDA granted clearance and authorization for the use of its artificial intelligence-based ICU solution, used to predict hemodynamic instability in adult patients.The solution, CLEWICU, continuously monitors and categorizes patient risk levels. This information provides clinicians with physiological insight into a patient’s likelihood of future hemodynamic instability and risks.

The clearance follows FDA's emergency use authorization for CLEWICU's respiratory deterioration model granted in June 2020. The solution has been used for the predictive screening of COVID-19 and other ICU patients.CLEWICU uses artificial intelligence-based algorithms and machine learning models trained to identify the likelihood of significant clinical events and emergencies occurring in patients in the ICU.

The system receives patient data from sources such as electronic health records (EHR) and medical device data. Experts then analyze and evaluate the data in real-time to present insights for artificial intelligence models and provide overall unit status.CLEW's AI-based solution is a huge leap forward in ICU patient care, providing preemptive and potentially life-saving information that enables early intervention, reduces alarm fatigue and can potentially significantly improve clinical outcome.