In a first, FDA authorizes AI-driven test to predict sepsis in hospitals

Bobby Reddy Jr. roamed a hospital as he built his start-up, observing how patient care began with a diagnosis and followed a set protocol. The electrical engineer thought he knew a better way: an artificial intelligence tool that would individualize treatment.

Now, the Food and Drug Administration has greenlighted such a test developed by Reddy’s company, Chicago-based Prenosis, to predict the risk of sepsis — a complex condition that contributes to at least 350,000 deaths a year in the United States. It is the first algorithmic, AI-driven diagnostic tool for sepsis to receive the FDA’s go-ahead, the company said in a statement Wednesday.