FDA issues landmark clearance to AI-driven ICU predictive tool

The U.S. Food and Drug Administration has authorized the use of CLEW Medical's artificial intelligence tool to predict hemodynamic instability in adult patients in intensive care units, the company announced on Wednesday.  

The tool, CLEWICU, uses AI-based algorithms and machine learning models to identify the likelihood of occurrence of significant clinical events for ICU patients.

CLEW says the clearance is the FDA's first for such a device.  

"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 and CLEW Advisory Board member, in a statement.  

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