Clew Medical recently received FDA emergency use authorization for its ClewICU System for use in intensive care units.
The EUA covers the company’s ClewICUServer and ClewICUnitor. The system is a standalone software that is designated as a medical device. It uses commonly recorded vital signs, nursing assessments, flowsheet data, medications and lab data to compute patient status indexes.
Data defined by the system includes CLEWRF, which is a measure of a patient’s predicted physiologic condition within the next eight hours based on the aggregate statistical risk of respiratory deterioration or failure, and CLEWHI, which is a measure of a patient’s predicted physiological condition within the next eight hours based on the aggregate statistical risk of hemodynamic instability.
The system is cleared for use in adults in ICU while treating COVID-19 as a diagnostic aid with the early identification of patients who are likely to experience respiratory failure or hemodynamic instability. This software is designed to be used as a decision support tool and to be used with a patient’s clinical history, continuous monitoring data, diagnostic test results and clinical judgement.
Clew Medical said the system is not able to predict sudden deterioration, but rather analyzes trends in data that occur over time.