Tuesday, September 05, 2023
Medimaps Group, a globally recognized Swiss med-tech company specializing in AI-driven image-processing software for bone health assessment, is pleased to announce its successful attainment of the Medical Device Regulation (MDR) certification from BSI (CE 2797), its appointed regulatory body. This certification encompasses both its corporate management system and product portfolio.
Prof. Didier Hans, co-founder and CEO of Medimaps Group, expressed his pride in this achievement, stating, "We take immense pride in being among the earliest AI-focused companies to attain MDR certification. By successfully navigating the rigorous MDR requirements, our company demonstrates its capacity to deliver innovative and dependable solutions that adhere to the most stringent regulatory standards. This benefits patients, healthcare practitioners, and our medical industry partners."
Meinhard F. Schmidt, Chairman of the Board of Directors of Medimaps Group, underscored the significance of the MDR framework in overseeing their product development, manufacturing, marketing, and safety monitoring processes. He added, "Achieving this complex regulatory milestone after a two-year effort underscores our commitment to the highest manufacturing standards and product traceability for our medical software."
The new MDR, introduced in Europe in May 2021, marks a significant transformation in the European healthcare regulatory landscape. This certification ensures that medical device manufacturers adhere to the strictest quality standards when introducing their products to the European market. It builds upon the 93/42/EEC directive certification held by the company for many years, affirming its stability and reliability in delivering top-quality products. MDR compliance has allowed Medimaps Group to enhance its clinical evaluation, technical design, and post-market surveillance processes.
With this certification in hand, Medimaps Group can seamlessly continue supplying its certified TBS iNsight™ software, which seamlessly integrates with dual-energy X-ray absorptiometry (DXA) scanners, X-rays, and CT PACs systems, to its valued customers in Europe and other markets without interruption. TBS iNsight™ plays a crucial role in measuring bone mineral density (BMD) to detect bone fragility in osteoporosis patients, offering advanced bone texture analysis related to bone micro-architecture. It complements BMD measurements and clinical risk factors, refining osteoporosis management without the need for additional examinations or radiation.
TBS iNsight™ has garnered recommendations in over 30 medical guidelines worldwide and has been featured in over 1,000 peer-reviewed scientific articles. It holds CE marking and FDA approval, making it commercially available in 60 countries worldwide. Furthermore, it qualifies for reimbursement in certain countries, including dedicated CPT codes in the USA.