FDA's AI medical device list shows authorization, not proven clinical benefit

The US FDA maintains a list of AI-enabled medical devices, which the author counted at 1,614 entries as of late October 2026, with about 76% in radiology. The FDA itself notes the list is not comprehensive, since devices were identified mainly through AI-related terms in their authorization summaries. Authorization reflects a regulatory process and does not establish that a tool improves patient outcomes in real clinical settings. The UK's NICE has placed some imaging-related AI tools, including four echocardiography tools, in an early-use category pending stronger evidence. The article argues the field's central question is shifting from whether AI works in a lab to whether it improves care in practice.