ICU Artificial Intelligence Care Tool Given First-Ever ‘OK’ By FDA

Artificial Intelligence (AI) technology is already transforming the healthcare industry, providing doctors and researchers with new ways of predicting, diagnosing, and treating illnesses. In an intensive care unit setting, predictive technology has particularly advantageous applications, allowing healthcare professionals to better anticipate complications and adapt treatment accordingly.

One such tool is CLEW Medical’s AI-driven predictive care tool known as CLEWICU, which was given a groundbreaking authorization by the FDA on February 3rd, clearing the way for its use in intensive care units (ICUs) to predict hemodynamic instability in adult patients.

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"CLEW's AI-based solution is a huge leap forward in ICU patient care, providing preemptive and potentially life-saving information that enables early intervention, reduces alarm fatigue and can potentially significantly improve clinical outcomes," stated University of Massachusetts Medical School Professor Craig Lilly.

By leveraging machine learning models and AI-based algorithms to help identify ICU patients likely to experience significant clinical events during the course of their care, the analytical software product may assist ICUs in better managing limited resources during an unprecedented time of strain on emergency health care systems. In particular, the tool is capable of predicting hemodynamic instability, which occurs when a patient has abnormal or unstable blood pressure.

In COVID-19 patients, hemodynamic instability can be a common complication, making this development even more timely. The tool’s ability to analyze patient data from various sources, including their electronic health record (EHR) and other medical devices, could help pinpoint high-risk patients up to eight hours prior to an event as well as identify those at lower risk for complications, enabling clinicians to make data-driven decisions sooner and provide early interventions for those in the greatest need.

The CLEWICU tool was given emergency use authorization by the FDA in June 2020 and has been one of several AI-based medical devices developed or modified over the course of the pandemic. The 510(k) authorization by the FDA marks a groundbreaking moment in the development of AI-based tools as medical devices, leading the way to further development and use of the technology as a means of not just identifying, but actively treating illness.

Mayo Clinic Chief Information Officer Cris Ross, in an opening keynote at the HIMSS Machine Learning & AI for Healthcare Digital Summit, enumerated the many ways AI technology has helped uncover crucial information about the novel coronavirus. From predicting numbers of new infections, to supporting research on mutations, to identifying symptoms, to assisting vaccine development, algorithms have been at the forefront of the fight against COVID-19. By leveraging large datasets provided by EHR systems, AI technology is providing additional tools that were simply unavailable in past years and is showing that investments in efforts to digitize healthcare are paying off.