AI intră în spitalele din SUA fără teste pe pacienți. Majoritatea dispozitivelor medicale autorizate nu au studii clinice

A study from the University of Toronto reveals that most AI-based medical devices approved in the U.S. lacked clinical evaluation prior to authorization. Out of over 1,300 devices approved by the FDA, only 34 were included in registered clinical studies. The approval process allows devices to be authorized based on substantial equivalence to existing devices, without demonstrating actual health benefits. Only three devices were tested for their impact on patient outcomes. The researchers highlight that many studies were conducted in high-resource medical systems and often excluded certain patient groups. They call for a reform in the approval process to ensure comprehensive evaluations across diverse patient categories.