Naitive Technologies’ OsteoSight Gains FDA Clearance for Early Osteoporosis Detection

UK-based Naitive Technologies has secured FDA 510(k) clearance for OsteoSight, its AI-driven software designed to evaluate bone mineral density (BMD) using standard X-rays. BMD loss underlies osteoporosis, a condition that weakens bones and increases fracture risk. Around 70% of patients with low BMD remain undiagnosed until a fracture occurs.

OsteoSight replicates the diagnostic accuracy of dual-energy X-ray absorptiometry (DEXA) scans and is indicated for evaluating the hip or pelvis in patients aged 50 years and older. Integrated into existing clinical workflows, it allows physicians to identify at-risk patients earlier and initiate timely interventions, such as prescribing bisphosphonates or parathyroid hormone analogs to preserve bone health.

With AI adoption in healthcare projected to reach $19bn by 2027, OsteoSight highlights AI’s growing impact on radiology by streamlining workflows and saving clinicians time. The tool is currently undergoing real-world validation at the UK’s Royal National Orthopaedic Hospital to support future NHS deployment.

15-09-2025