- TBS Reveal™ receives CE MDR certification as a Class IIa medical device, now available for clinical use across Europe
- TBS Reveal™ uses AI to identify bone-fragility risk from routine X-rays already being taken — no new scan, no new visit
Geneva, Switzerland — June 25, 2026
Medimaps — the creator of TBS® (Trabecular Bone Score®), the global standard in bone microarchitecture assessment — today announced that TBS Reveal™ has received CE certification as a Class IIa medical device under Regulation (EU) 2017/745 on Medical Devices (EU MDR), following conformity assessment under Annex IX (Chapters I and III).
Addressing osteoporosis, the silent disease
Osteoporosis affects more than 500 million people worldwide, yet it often goes undetected until a fracture occurs. More than 70% of patients with fragility fractures are never tested or treated for osteoporosis.¹
At the same time, millions of patients undergo routine X-ray imaging every year for unrelated reasons, which represents an untapped opportunity to assess bone health from images that already exist.
TBS Reveal™ is designed to help shift bone care from reaction to prevention: To surface fragility risk before the first fracture, rather than diagnosing osteoporosis only after a break has occurred.
TBS Reveal™ is an AI software that analyses routine X-ray images to provide a TBS® value related to trabecular bone microarchitecture and a classification of bone fragility, generating structured bone-health outputs for clinical review. Trained using DXA-derived Trabecular Bone Score® and osteoporosis classification as clinical ground truth, it is designed to support opportunistic case-finding and to complement — not replace — established clinical assessment pathways.
“Every day, patients at risk of fracture pass through radiology departments without their bone health ever being assessed. With TBS Reveal, the X-rays we already take become an opportunity to find these patients earlier — before the first fracture, not after it,"
said Didier Hans, CEO and Co-founder of Medimaps.
Backed by strong clinical evidence
TBS Reveal™ has been validated through international, multi-centre cohort studies. A study published in eClinicalMedicine (part of The Lancet Discovery Science) in 2026 demonstrated strong potential for identifying bone-fragility risk from conventional radiographs.²
“This certification validates years of rigorous clinical development. Fragility fractures cost European health systems an estimated €57 billion annually, and the imaging needed to intervene earlier is, in many cases, already being performed,"
said Gino Fiore, Chief Commercial Officer at Medimaps.
TBS Reveal™ reads routine X-rays within existing radiology workflows. It was added to Medimaps’s MDR certificate (no. C831120, issued by DNV Product Assurance AS, notified body 2460) on 25 June 2026. The certification makes TBS Reveal™ available for clinical use across Europe, enabling clinicians to identify bone-fragility risk from X-rays already being captured in routine care. FDA clearance is pending; TBS Reveal™ is not available for clinical use in the United States.
What’s next for TBS Reveal
CE certification is a milestone, not a destination. Because TBS Reveal™ draws its insight from imaging that is already being performed, it points toward a future in which bone fragility can be identified opportunistically, wherever an X-ray is taken, long before a first fracture forces the question.
Realizing that future means widening access: continuing to build the clinical evidence base and pursuing further regulatory clearances, including in the United States.
"An osteoporotic fracture should be the thing we prevent, not the event that finally prompts a diagnosis. Certification in Europe is the first step toward putting opportunistic bone-health assessment within reach of every clinician who already relies on X-ray, and toward an era where healthy bones are the norm,"
said Didier Hans.
TBS Reveal™ is intended exclusively for healthcare professionals and is not available for purchase by the general public. TBS Reveal is a Class IIa medical device, CE marked under EU MDR 2017/745 (CE 2460). FDA clearance is pending; TBS Reveal is not available for clinical use in the United States. Manufacturer: Medimaps Group SA, Chemin du Champ-des-Filles 36A, 1228 Plan-les-Ouates, Geneva, Switzerland. Always follow the instructions for use.
References:
1. Compston, J. (2020). Reducing the treatment gap in osteoporosis. The Lancet Diabetes & Endocrinology, 8(1), pp.7–9. doi:10.1016/S2213-8587(19)30378-X
2. Gatineau, G., De Gruttola, M., Hind, K., Davies, M., Krueger, D., Binkley, N., Kužma, M., Payer, J., Guglielmi, G., Fahrleitner-Pammer, A., Chun, K., Bencardino, J., Sherman, A., Jones, K. and Hans, D. (2026). Validation of a deep learning model for bone fragility detection from conventional radiographs: an international cohort study. eClinicalMedicine, 95, p.103974. doi:10.1016/j.eclinm.2026.103974