Avertisment despre dispozitivele medicale cu AI: Majoritatea nu au fost testate pentru efectele reale asupra pacienților

A recent analysis reveals that very few AI-based medical devices authorized in the U.S. underwent clinical trials prior to approval. Researchers examined over 1,300 devices to assess their health impact testing. Only 34 devices were included in registered clinical studies, with just three evaluated based on patient-centered outcomes. The study highlights potential inequalities in healthcare, as many devices may not be adequately tested for diverse populations. The authors suggest rethinking current approval policies to ensure efficacy across various patient groups and healthcare systems.