CLEW Medical Earns FDA Clearance for ICU Patient-Assessment Tool

CLEW Medical has received 510(k) clearance for CLEWICU, an artificial intelligence-based device that is used to predict hemodynamic instability — abnormal or unstable blood pressure — in adult intensive care patients.

The technology continuously monitors and categorizes patient risk levels using electronic health records and medical device data, offering clinicians insights into a patient’s risk of future hemodynamic instability.

The system gives notifications of clinical deterioration up to eight hours in advance, enabling early intervention. It also identifies low-risk patients unlikely to have blood pressure complications.