AI-Based ICU Solution for Predicting Patient Deterioration Becomes Industry’s First Ever Device to Receive FDA Clearance

A new artificial intelligence (AI) based ICU solution for predicting the likelihood of patient deterioration up to eight hours in advance has become the industry’s first ever device to receive clearance from the US Food and Drug Administration (FDA).

The FDA has given 510(k) clearance and authorized the use of “CLEWICU,” an AI-based ICU solution from CLEW Medical (Netanya, Israel), to predict hemodynamic instability in adult patients. The clearance is the FDA’s first for such a device, and follows the FDA’s Emergency Use Authorization (EUA) for the company’s respiratory deterioration model granted in June 2020, for the predictive screening of COVID-19 and other ICU patients.

The COVID-19 pandemic has underscored the critical need for quick and accurate decision-making in intensive care units, as ICU capacity has faced unprecedented volumes. Conducting effective risk evaluation to improve patient identification and subsequent care plans requires the use of advanced tools that can provide comprehensive, predictive data to help medical professionals identify patients whose health conditions are likely to deteriorate, in addition to patients whose conditions are unlikely to deteriorate.

CLEWICU continuously monitors and categorizes patient risk levels, providing clinicians with physiological insight into a patient’s likelihood of future hemodynamic instability. The system provides notification of clinical deterioration up to eight hours in advance, enabling early evaluation and subsequent intervention for prompt, proactive patient care. The system also identifies low-risk patients who are unlikely to deteriorate, thus enabling better ICU resource management and optimization.

The analytical software product uses AI-based algorithms and machine-learning models trained to identify the likelihood of occurrence of significant clinical events for patients in the ICU. CLEWICU receives patient data from various sources, including Electronic Health Record (EHR) data and medical device data. 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.

“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.

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