Medimaps group S.A., a Swiss developer of artificial intelligence (AI)-driven bone microarchitecture imaging, has received U.S. Food and Drug Administration (FDA) 510(k) clearance and MDR certification in the EU for the latest version of its flagship TBS Osteo trabecular bone score (TBS) software.

The next-gen software was designed to enhance evaluation of bone microarchitecture, expand patient eligibility, and improve connectivity in medical facilities. Medimaps plans to release the next-gen of TBS Osteo in its current 90 markets across the world.

TBS Osteo converts DXA scan data into precise, actionable reports to complement bone mineral density measurements and clinical risk factors. This way, clinicians have a comprehensive tool to evaluate osteoporotic fracture risks.

The software’s role extends to research and pharmaceutical clinical trials in the fields of women’s health, rheumatology, endocrinology, oncology, and sports medicine, addressing bone fragility as a critical health concern in pathologies impacting bone integrity.

The next-gen software expands eligibility beyond standard BMI (body mass index) ranges with direct tissue thickness assessment. Multiple DXA systems can be integrated in medical facilities. A redesigned interface simplifies integrating TBS Osteo into routine clinical workflow, the company said.

“At Medimaps, we understand the growing pressures faced by radiology departments,” said Univ.-Prof. Dr. Didier Hans, co-founder and CEO of medimaps. With the next generation of TBS Osteo, we’re equipping clinicians with the tools they need to deliver exceptional care efficiently, without compromising clinical standards.”

TBS Osteo remains the only approved medical device software for evaluating bone microarchitecture in clinical settings. Since 2022, it benefits from four Category 1 reimbursement CPT codes in the U.S.