Health IT Innovation

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.  


Hemodynamic instability is a common COVID-19 complication, so CLEWICU’s predictive capabilities could prove especially useful during the ongoing pandemic – particularly given ICUs’ strained resources around the country.

By analyzing patient data from various sources, including electronic health records and medical devices, CLEWICU provides a picture of overall unit status and helps identify individuals whose conditions are likely to deteriorate.

According to the company, the system notifies users of clinical deterioration up to eight hours in advance, enabling early intervention. The system also identifies low-risk patients who are unlikely to deteriorate, thus potentially 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 lifesaving information that enables early intervention, reduces alarm fatigue and can potentially significantly improve clinical outcomes,” said Dr. Craig Lilly of University of Massachusetts Medical School in a statement.  


The FDA granted emergency use authorization to CLEWICU back this past June. The tool was among several AI-powered technology innovations developed, or modified, in response to the ongoing pandemic.   

Mayo Clinic Chief Information Officer Cris Ross said in December that AI has been crucial in understanding the pandemic. He noted the variety of COVID-19-specific use cases, while he also flagged the risk of algorithmic bias.

“We know that Black and Hispanic patients are infected and die at higher rates than other populations. So we need to be vigilant for the possibility that that fact about the genetic or other predisposition that might be present in those populations could cause us to develop triage algorithms that might cause us to reduce resources available to Black or Hispanic patients because of one of the biases introduced by algorithm development,” said Ross.  


“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, in a statement.

Kat Jercich is senior editor of Healthcare IT News.
Twitter: @kjercich
Healthcare IT News is a HIMSS Media publication.

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