Medimaps Achieves FDA Clearance for Enhanced Fracture Risk Software
Revolutionizing Fracture Risk Assessment
In a groundbreaking development, Medimaps group S.A., a leader in innovative imaging solutions for bone health, has achieved significant milestones with the recent clearance of their TBS Osteo software. This software has received both 510(k) clearance from the FDA and MDR certification in the European Union, marking a notable advancement in fracture risk assessment technologies.
Innovative Features of TBS Osteo
The latest iteration of TBS Osteo is designed to enhance the evaluation of bone microarchitecture and improve clinicians’ ability to assess fracture risk. The software aims to broaden patient eligibility, making advanced assessments accessible to a more diverse population, which is critical in today’s healthcare landscape.
Expanding Patient Eligibility
One of the most significant enhancements to TBS Osteo is its ability to assess a broader range of patient profiles. With the introduction of direct tissue thickness assessment, the software can now offer evaluations to patients outside traditional BMI limits. This development ensures that various groups can benefit from comprehensive fracture risk assessments, ultimately leading to improved patient outcomes.
Seamless Integration of Systems
The new TBS Osteo platform also emphasizes enhanced connectivity. By allowing integration between different DXA systems in medical facilities, the software promotes a more seamless exchange of data. Clinicians can access information remotely and securely, facilitating a more efficient workflow in radiology departments and ensuring clinicians have instant access to vital patient data.
User-Friendly Interface
To further support healthcare professionals, Medimaps has redesigned the user interface of TBS Osteo, making it more intuitive and easier to navigate. This focus on usability enables clinicians to incorporate TBS Osteo into their routine practice effortlessly, improving the efficiency and standard of care they provide.
The Trusted Solution in Bone Health Assessment
With over 4 million procedures performed annually, TBS Osteo has become a trusted tool for assessing and monitoring bone health, especially among patients at risk of osteoporosis. It is recognized and endorsed by more than 30 national and international clinical guidelines, solidifying its position as a reliable choice for healthcare providers.
Impact on Clinical Research and Practice
TBS Osteo's applications extend beyond routine clinical use; it is also utilized extensively in clinical research and drug trials. The software plays a vital role in researching women’s health, rheumatology, endocrinology, oncology, and sports medicine. Its contributions to understanding bone fragility are crucial in tackling health concerns related to patient bone integrity.
About Medimaps
Founded by a dedicated team of medical professionals and clinical researchers, Medimaps embodies a spirit of innovation enriched by Swiss expertise. The company focuses on advancing bone health management through AI-driven software that provides accurate assessments of bone microarchitecture.
Medimaps is committed to musculoskeletal health, leveraging scientific research, collaborations with top experts, and feedback from healthcare professionals and patients. This multifaceted approach ensures that their imaging applications are at the forefront of clinical and research advancements in bone health.
Frequently Asked Questions
What is TBS Osteo?
TBS Osteo is a next-generation software developed by Medimaps for evaluating bone microarchitecture, crucial for assessing osteoporotic fracture risk.
What certifications has TBS Osteo received?
TBS Osteo has achieved FDA 510(k) clearance and MDR certification in the EU, ensuring it meets rigorous standards for medical devices.
How does TBS Osteo improve patient care?
The software expands patient eligibility and provides actionable reports, enabling clinicians to deliver comprehensive fracture risk assessments effectively.
In which fields is TBS Osteo utilized?
TBS Osteo is used in various fields, including women’s health, rheumatology, and oncology, contributing significantly to clinical research and outcomes.
What is Medimaps' mission?
Medimaps is dedicated to advancing bone health management through innovative technology, benefiting healthcare professionals and patients worldwide.
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