Medimaps Group S.A., a global leader in AI-driven bone imaging solutions, has received FDA 510(k) clearance and MDR certification in the EU for the latest version of its Trabecular Bone Score (TBS) software, TBS Osteo. The next-generation software is set to transform how clinicians assess bone health, providing enhanced capabilities for evaluating bone microarchitecture and fracture risk.
The newly updated software broadens patient eligibility for bone health assessments, offering innovative tools to medical professionals. With expanded connectivity features and a user-friendly design, the software aims to improve workflows in clinical settings globally. Medimaps plans to roll out TBS Osteo’s latest version across its 90 existing markets.
The software is the only approved medical device for bone microarchitecture evaluation in clinical settings. Complementing bone mineral density (BMD) measurements, TBS Osteo analyses data from DXA scans to provide a more comprehensive fracture risk assessment. This allows clinicians to make more informed decisions, especially for patients at risk of osteoporosis and other bone-related conditions.
Professor Didier Hans, CEO and co-founder of Medimaps, explained the motivation behind the advancements. “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,” he said.
Medimaps has dedicated over 14 years to developing TBS Osteo, which is now supported by over 30 national and international clinical guidelines. It plays a critical role in fields such as women’s health, rheumatology, endocrinology, oncology, and sports medicine.
Key features of the next-generation TBS Osteo software include:
- Inclusive patient care: The software now evaluates patients beyond standard BMI ranges, using direct tissue thickness assessments to accommodate a broader and more diverse range of individuals.
- Seamless connectivity: It integrates with multiple DXA systems within medical facilities, enabling secure, remote access to data from any networked device and improving operational efficiency.
- Enhanced usability: A redesigned interface simplifies clinical workflows, making it easier for healthcare providers to adopt and use the software in routine practice.
Since 2022, TBS Osteo has benefited from four Category 1 reimbursement CPT codes in the United States, further supporting its accessibility for clinicians and patients. With over 4 million procedures performed annually, it has become a trusted tool for assessing and monitoring bone health.
Medimaps’ next-generation software is also used in pharmaceutical clinical trials to address bone fragility in conditions that impact bone integrity. The company’s commitment to advancing bone health technologies ensures TBS Osteo remains at the forefront of clinical innovation, helping to combat osteoporosis and related conditions worldwide.