FDA approves ICU AI to predict the lethal COVID-19 related complications

  |   June 09, 2020

The FDA recently granted an emergency authorization to the CLEW Medical’s remote data monitoring system that will help to predict and identify the virus affected patients under intensive care who are most likely at risk for insufficient blood flow or a potential respiratory failure. CLEWICU, the company’s artificial intelligence software, takes in a wide range of patient data by linking itself to the electronic medical records, all the connected medical devices, and the vital sign monitors, with absolutely no need for additional data entry to be done by the ICU staff. It helps save a lot of time as well. Along with alerting the providers about a patient’s potentially deteriorating health as a diagnostic aid, the real-time risk classification model of the system also helps predict which patients may or may not require any kind of interventions within an eight-hour period. 

The FDA also stated that the standalone CLEWICU software, based within the hospital premises or in the cloud, can significantly help in reducing the contact between the healthcare professionals and the virus affected patients with the help of remote monitoring. According to the FDA, by identifying the high-risk patients, prioritizing the treatment on the basis of patient acuity, and reducing the false alarm rate remarkably, the software provides better and efficient care for the patients and highly reduces the strain on the ICU personnel. 

According to the previous validation studies of CLEW, the system was capable of providing accurate positive alerts predicting a hemodynamic instability or an impending respiratory failure in a patient by a median of three-and-a-half hours. The company also has previously submitted an application for a full 510(k) FDA clearance while the system underwent testing at the tele-ICU facilities at UMass Memorial Medical Center and the WakeMed health system in Raleigh in North Carolina.

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