BoneView

By Gleamer
AI-powered fracture detection software (Gleamer) that flags and localizes suspected fractures on standard adult and pediatric radiographs, as a second-reader aid for emergency and orthopedic imaging.
Diagnostic
Radiology
Regulatory status
Deployment
Clinical role
Adjunct (decision support)
Headquarters
AI type
Diagnostic

Precise indication

BoneView (Gleamer) is a computer-aided detection software that helps detect and localize fractures on standard radiographs (X-ray). It flags suspected fractures on the image to support the reader, in adult and pediatric patients.

Scope: conventional radiography only (trauma, emergency and orthopedic settings). It does not analyze CT or MRI, and it does not cover pathologies other than fractures.

Use: second-reader (adjunctive) tool. It does not replace the radiologist or emergency physician, who remain responsible for the final diagnosis.

Related product: ChestView, a separate Gleamer product for chest radiographs, has its own indication and clearance and is not covered by this fiche.

Regulatory status

Clinical evidence

Vendor-supported
Independent

Real-world deployment

Interoperability

European status

Editorial verdict

Limits and uncertainties

– Sensitivity gain is well established and consistent across studies. The specificity effect is uncertain: it rose in some studies, fell in others and stayed stable in others.
– High risk of bias in 5 of the 8 studies included in the independent systematic review (Kwee et al., 2025), mainly patient selection. Results also vary markedly between studies (heterogeneity, p ≤ 0.0001).
– The founding study (Duron et al., Radiology, 2021) was retrospective and published with the vendor’s support.
– Designed as a second-reader tool, not a substitute for the radiologist or emergency physician, who keep responsibility for the final diagnosis.
– Standard radiographs only: no CT or MRI, and no pathology other than fractures.
– The deployment figure (2,500+ clinical sites for Gleamer products) is declared by the vendor and has not been independently audited.
– CE marking not confirmed from the public sources reviewed. PACS/RIS integration details are not independently verified: confirm both with Gleamer before any deployment decision.

Sources

FDA clearance of BoneView (Gleamer press release, PRNewswire, April 2022): https://www.prnewswire.com/news-releases/gleamer-receives-fda-clearance-for-its-artificial-intelligence-software-to-help-detect-and-localize-fractures-301493376.html Founding study, Duron et al., Radiology, May 2021 (vendor summary of results): https://www.gleamer.ai/insights/radiology2021 Independent systematic review, Kwee et al., European Journal of Radiology, 2025: https://www.sciencedirect.com/science/article/abs/pii/S0720048X2500316X Deployment figure, 2,500+ sites (vendor page, declared, not audited): https://www.gleamer.ai/benefits/hospitals

This profile is not medical advice or an endorsement. Hospitals should perform their own due diligence (regulatory compliance, GDPR, cybersecurity, integration, local clinical validation). How we evaluate

At a glance
Vendor
Gleamer
Headquarters
AI type
Diagnostic
Specialty
Clinical role
Adjunct (decision support)
CE marking
Notified body
EU AI Act
Data hosting
Last verified
Reviewed by
How we evaluate

Every profile documents the precise indication, regulatory status, vendor-supported and independent evidence, real-world deployment, limits and dated sources.

A independent systematic review or prospective multicentre study · B at least one independent peer-reviewed study · C peer-reviewed, vendor-supported · D vendor claims only.

Read the methodology →

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