Medimaps Breaks New Ground in Fracture Risk Assessment with FDA Clearance and MDR Certification for TBS Osteo Next Generation Software

GENEVA--(BUSINESS WIRE)--medimaps group S.A., a global leader in AI-driven bone microarchitecture imaging solutions, proudly announces 510(k) clearance from FDA and MDR certification in EU for the latest version of its flagship Trabecular Bone Score (TBS) 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 is planning to rollout the next generation of TBS Osteo in 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"

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“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 in clinical settings. Since 2022 it benefits 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 risks in patients. 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 enables to integrate 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 the field of women’s health, rheumatology, endocrinology, oncology, and sports medicine, addressing bone fragility as a critical health concern in pathologies impacting bone integrity.

About Medimaps

Founded by medical practitioners and clinical researchers, Medimaps combines Swiss innovation with a global presence to lead in bone health management.​ We provide healthcare professionals worldwide with advanced AI-driven software that enables comprehensive bone microarchitecture assessment.

Our passion for musculoskeletal health is underpinned by scientific knowledge, collaborations with world-class academics, clinicians, industry partners, and direct patient engagement. The science behind our cutting-edge imaging applications and clinical evidence forms the core of our company’s DNA.​

Learn more at www.medimaps.ai