Summary: The FDA has cleared CLEWICU, CLEW Medical’s AI-based ICU solution, for predicting hemodynamic instability, marking the first such clearance. The system uses AI to monitor and predict patient risk levels, aiding early intervention and resource optimization in ICUs.

Key Takeaways:

Historic FDA Clearance: CLEWICU is the first AI-based ICU device to receive FDA clearance for predicting hemodynamic instability.
Predictive Capabilities: The system provides advance warnings of clinical deterioration, enhancing proactive patient care.


CLEW Medical announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance and authorized the use of “CLEWICU,” CLEW’s artificial intelligence (AI) based ICU solution, to predict hemodynamic instability in adult patients.

FDA Clearance for Predictive AI in ICU

The clearance is the FDA’s first for such a device, according to the company, and follows 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. 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.

CLEW’s Advanced AI Algorithms

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 intensive care unit (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.

“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.