Imaging: fractures and bone: what the evidence shows
Software that marks suspected fractures, dislocations and joint effusions on radiographs, or flags vertebral compression fractures on CT scans done for other reasons, for the reading clinician.
These tools read radiographs for fractures, dislocations and joint effusions, or read CT scans done for other reasons for vertebral compression fractures, and mark findings for the reading clinician. FDA created the main device type, radiological computer-assisted detection and diagnosis software for fracture, when it granted the De Novo request for OsteoDetect on May 24, 2018; later fracture tools were cleared by 510(k) under that classification.
Most evidence comes from reader studies, in which clinicians read enriched case sets with and without the software. A 2026 meta-analysis pooling 17 studies found AI assistance raised clinicians' sensitivity from 73% to 87%, with specificity of 94% unaided and 95% aided, and the largest gains among junior clinicians. All 16 studies in a meta-analysis of foot and ankle fracture detection were retrospective. Randomized trials in routine care have begun: a trial at three hospitals in Austria and Germany finished enrolling in April 2026 without published results, and a U.K. cluster randomized trial began recruiting in January 2026. Open questions include whether flagged findings change treatment, recalls for missed fractures and time in the emergency department.
The tools reviewed in this category
General information, not medical advice. Every fact links to its source, and the page shows the date it was last reviewed.