Sam Brusco, Associate Editor02.04.21
The U.S. Food and Drug Administration (FDA) has given 510(k) clearance and authorized use of CLEWICU, CLEW Medical's artificial intelligence (AI) based ICU solution, to predict hemodynamic instability in adult patients. According to the company this is the FDA's first clearance for such a device. It follows last June’s FDA authorization for CLEWICU's respiratory deterioration model for predictive screening of COVID-19 and other ICU patients.
CLEWICU continuously monitors and categorizes patient risk levels, providing physiological insight into likelihood of future hemodynamic instability. The system notifies of clinical deterioration up to eight hours in advance, enabling early evaluation and subsequent intervention. The system also identifies low-risk patients unlikely to deteriorate, allowing for improved ICU resource management and optimization.
The analytical software product uses AI-based algorithms and machine-learning models trained to identify likelihood of occurrence of significant clinical events for ICU patients. CLEWICU receives patient data from both EHRs and medical devices, which is analyzed in near real-time to show 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," Gal Salomon, CLEW CEO told the press.
"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.
"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 continuously monitors and categorizes patient risk levels, providing physiological insight into likelihood of future hemodynamic instability. The system notifies of clinical deterioration up to eight hours in advance, enabling early evaluation and subsequent intervention. The system also identifies low-risk patients unlikely to deteriorate, allowing for improved ICU resource management and optimization.
The analytical software product uses AI-based algorithms and machine-learning models trained to identify likelihood of occurrence of significant clinical events for ICU patients. CLEWICU receives patient data from both EHRs and medical devices, which is analyzed in near real-time to show 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," Gal Salomon, CLEW CEO told the press.
"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.
"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.