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2 stories found

A radiology scan passes through separate European and United States regulatory gates while two clocks show sharply different waits and shared evidence remains visible between them.
Social good & healthEuropean Union and United States+2 clusters01

Radiology AI faces a 14-month transatlantic approval gap

A peer-reviewed npj Digital Medicine study analyzed 239 AI-enabled radiology software devices with a European CE mark, United States Food and Drug Administration clearance, or both. Of the sample, 128 had only a CE mark, 95 received a CE mark before FDA clearance, and 16 received FDA clearance first. Among dual-authorized devices, the median wait for the second authorization was 17.5 months when the CE mark came first, compared with 3.5 months when FDA clearance came first. Radiograph-interpretation software was associated with a longer wait, while European Class IIa classification was associated with a shorter interval. The observational study identifies sequencing and association; it does not establish why every delay occurred or that one regulator's decision is superior. Its policy value is the asymmetry. Developers, hospitals, and regulators need clearer, comparable evidence requirements so validated safety information can travel across jurisdictions without converting coordination into weaker scrutiny.

5 min
A wall of 1,357 medical-device approval tiles narrows to three illuminated patient-outcome records beside an empty hospital evidence chart.
Social good & healthUnited States · Global implications+3 clusters02

Only three of 1,357 FDA-authorized AI medical devices were evaluated on patient outcomes

A PLOS Digital Health evidence census linked the FDA's 1,357 authorized AI and machine-learning medical devices through December 5, 2025 to prospective trials and publications. Thirty-four devices were linked to registered prospective trials, 12 had posted results, 12 had peer-reviewed publications, and only three evaluated patient-centered outcomes such as mortality, morbidity, or readmission. The review does not show that the remaining devices are ineffective; it shows that authorization and benchmark performance rarely answer the outcome question patients care about most. With 78 percent of the devices concentrated in radiology and vulnerable populations often excluded from studies, the validation gap can travel through hospitals and across countries long before durable benefit or equitable performance is known.

5 min