In 2021, an AI system did something no artificial intelligence had done before: it earned FDA clearance to help diagnose cancer. Built by a company called Paige — now part of Tempus AI — the technology doesn’t replace pathologists. It works alongside them, scanning digitized biopsy slides and flagging regions a human eye might miss. Independent studies show real gains in cancer detection. But the evidence also reveals what’s still unproven — from patient outcomes to training-data transparency. Here’s what the research actually shows.