CE Class IIa (MDR 2017/745, EU) and FDA Class II 510(k) (US), both confirmed. Shortlisted by NICE’s Early Value Assessment (UK) — not yet a formal clinical recommendation.
Clinical evidence
Vendor-supported
Vendor content on azmed.co.
Independent
Independent prospective study (Technical University of Munich, 2025, 1,037 patients / 2,926 radiographs) comparing Azmed, Gleamer and Radiobotics: AUC 84.9% (all fractures), 61.9% (dislocations), 58.0% (effusions). Conclusion: adjunct tools, not a replacement for the radiologist.
Real-world deployment
No exact figure found, but NICE shortlisting suggests active NHS interest.
Interoperability
European status
Editorial verdict
Limits and uncertainties
Weaker and more heterogeneous performance on complex scenarios (dislocations, effusions) than on simple fractures; NICE assessment is not yet a definitive clinical recommendation.
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
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.