FDA Lists More Than 1,500 AI-Enabled Medical Devices as Oncology Applications Expand

oncodaily - The U.S. Food and Drug Administration (FDA) has listed more than 1,500 artificial intelligence-enabled medical devices authorized for marketing in the United States, reflecting the growing integration of AI across […]

AI Summary: The FDA catalogued more than 1,500 AI‑enabled medical devices, spurring criticism that most were cleared without direct evidence they improve patient outcomes. Regulators and clinicians face mounting calls for post‑market studies and transparency, balancing enthusiasm for AI innovation against the sober question: do these devices actually help patients?