FDA Approves Use of AI Tool Predicting Adverse Events In ICU

The FDA has agreed to a special authorization allowing a vendor to deploy its AI tool designed to predict adverse events in hospital ICUs.

The agency issued an Emergency Use Authorization for an ICU solution developed by CLEW Medical, whose CLEW-ICU uses predictive screening to identify patients with a higher likelihood of being diagnosed with serious conditions such as respiratory failure or hemodynamic instability. These conditions are frequently associated with COVID-19.

CLEW trained its AI using data on nearly 100,000 patients in ICUs. The AI-based algorithms are machine-learning models trained to predict such problems hours in advance. The product, CLEW-ICU, integrates care delivered by local and remote teams. According to the vendor, this clearance is the FDA’s first for technology in this category.

The FDA authorization follows a steadily increasing deployment of predictive tools in the emergency department, ICU and other hospital areas where patients might be at risk of sudden decline. These tools have been particularly popular as the pandemic has raged on, bringing in patients in particularly sensitive and volatile conditions.