As the COVID-19 pandemic has periodically pushed ICUs around the world to the limit, practitioners have become acutely aware of the need for evaluative tools that can help them quickly and accurately identify whether or not a patient’s health conditions are likely to deteriorate.

To that end, the U.S. Food and Drug Administration (FDA) recently approved “CLEWICU,” an AI-based solution for ICU’s, developed by Tel Aviv-based CLEW Medical, that can help predict hemodynamic instability, a common COVID-19 complication, in adult patients.  The approval comes on the heels of the FDA's Emergency Use Authorization (EUA) for CLEWICU's respiratory deterioration model granted in June 2020, for the predictive screening of COVID-19 and other ICU patients.

"AI can be a powerful force for change in healthcare, enabling assessment of time-critical patient information and predictive warning of deterioration that could enable better informed clinical decisions and improved outcomes in the ICU," said Dr. David Bates, Medical Director of Clinical and Quality Analysis in Information Systems at Mass General Brigham healthcare system and CLEW Advisory Board member.

CLEWICU continuously monitors and categorizes patient risk levels, providing clinicians with physiological insight into a patient's likelihood of future hemodynamic instability. The system also identifies low-risk patients who are unlikely to deteriorate, thus enabling better ICU resource management and optimization.

"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 outcomes," stated Professor Craig Lilly, University of Massachusetts Medical School.

CLEWICU receives patient data from various sources, including EHR data and medical device data, then uses AI-based algorithms and machine-learning models trained to identify the likelihood of occurrence of significant clinical events for patients in the ICU. The data is analyzed in near real-time to present calculated insights and notifications for dedicated AI models and provides a picture of overall unit status.

”We are proud to have received this landmark FDA clearance and deliver a first-of-its-kind product for the industry, giving healthcare providers the critical data that they need to prevent life-threatening situations," said Gal Salomon, CLEW CEO.