Medimaps receives CE MDR certification for TBS Reveal, bringing opportunistic bone-fragility assessment to routine x-rays
Medimaps, the creator of TBS (Trabecular Bone Score) – the global standard in bone microarchitecture assessment, has announced that TBS Reveal has received CE certification as a Class IIa medical device under EU MDR 2017/745, making it available for clinical use across Europe.
Osteoporosis affects more than 500 million people worldwide, yet often goes undetected until a fracture occurs as more than 70 per cent of patients with fragility fractures are never tested or treated. At the same time, millions of patients undergo routine x-ray imaging every year for unrelated reasons, representing 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, surfacing fragility risk before a first fracture rather than after one.
TBS Reveal is AI software that analyses routine x-rays to generate a TBS value and bone-fragility classification, trained using DXA-derived TBS and osteoporosis classification as clinical ground truth. It is designed to support opportunistic case-finding alongside, not in place of, established clinical assessment pathways.
“Every day, patients at risk of fracture pass through radiology departments without their bone health ever being assessed,” said Professor Didier Hans, CEO and co-founder of Medimaps. “With TBS Reveal, the x-rays we already take become an opportunity to find these patients earlier — before the first fracture, not after it.”
TBS Reveal has been validated through international, multi-centre cohort studies, including a study recently published in eClinicalMedicine (part of The Lancet Discovery Science) demonstrating strong performance for identifying bone-fragility risk from conventional radiographs.
“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 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.
This news story has been sponsored by the companies concerned and does not represent the views or opinions of RAD Magazine.
