AI-based predictive analytics tool receives FDA 510(k) clearance

Feb. 17, 2021

CLEW Medical, a developer of predictive analytics using artificial intelligence (AI), announced that the U.S. Food and Drug Administration (FDA) has given 510(k) clearance for the use of CLEW’s AI-based ICU solution, which predicts hemodynamic instability in adult patients, according to a press release from the company.

The clearance follows the FDA’s emergency use authorization (EUA) in June 2020 for CLEWICU’s respiratory deterioration model, which was granted for the predictive screening of COVID-19 and other ICU patients.

The company said that 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 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, the company said.

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