- FDA 510(k) clearance and EU MDR certification secured for the next-generation TBS Osteo™ software
- TBS Osteo's next generation expands fracture risk assessment capabilities to assist a broader range of patient profiles
- Advanced connectivity and usability features streamline operations across medical facilities
Geneva, Switzerland — January 27, 2025
Medimaps — the creator of TBS® (Trabecular Bone Score®), the global standard in bone microarchitecture assessment — today announced 510(k) clearance from the FDA and MDR certification in the EU for the latest version of its flagship software, TBS Osteo™. This next-generation software is designed to enhance bone microarchitecture evaluation, broaden patient eligibility, and improve connectivity within medical facilities. The company plans to roll out the next generation of TBS Osteo™ across its current 90 markets worldwide.
"At Medimaps, we understand the growing pressures faced by radiology departments. 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."
said Univ.-Prof. Dr. Didier Hans, CEO and Co-founder of Medimaps.
TBS Osteo™ remains the only approved medical device software for evaluating bone microarchitecture using TBS® in clinical settings. Since 2022, it has benefited from four Category 1 reimbursement CPT codes in the US.
By converting DXA scan data into precise, actionable reports, TBS Osteo™ complements bone mineral density measurements and clinical risk factors, providing clinicians with a comprehensive tool for assessing osteoporotic fracture risk. Medimaps has dedicated over 14 years to the ongoing development of TBS Osteo™, striving to meet the evolving needs of both patients and clinicians. TBS Osteo™ next generation introduces significant advancements:
- Inclusive patient care: expanded eligibility beyond standard BMI ranges with direct tissue thickness assessment, ensuring a broader, more diverse patient population benefits from fracture risk evaluation.
- Seamless connectivity: the new platform integrates multiple DXA systems within medical facilities, offering secure, remote access to data from any networked computer and streamlining clinical operations.
- Enhanced usability: a redesigned, user-friendly interface simplifies the integration of TBS Osteo™ into routine clinical workflow.
With over 4 million procedures performed annually and endorsements from more than 30 national and international clinical guidelines, TBS Osteo™ has become a trusted tool in the assessment and monitoring of bone health in patients developing osteoporosis. Its role extends to research and pharmaceutical clinical trials in women’s health, rheumatology, endocrinology, oncology, and sports medicine, addressing bone fragility as a critical concern in pathologies impacting bone integrity.