Medimaps Group, a distinguished Swiss/Global medical technology company specializing in AI-powered image-processing software for evaluating bone health, proudly announced today that it has received certification under the Medical Device Regulation (MDR) from its notified body BSI (CE 2797), encompassing its management system and product portfolio.

Prof. Didier Hans, co-founder and CEO of Medimaps Group, expressed their pride in being among the early AI companies to attain MDR certification. He stated, "By successfully meeting the stringent requirements of the Medical Device Regulation, our company demonstrates its capacity to deliver innovative and trustworthy solutions that adhere to the highest regulatory standards, benefiting patients, healthcare professionals, and medical industry partners."

Meinhard F. Schmidt, Chairman of the Board of Directors of Medimaps Group, emphasized the importance of the MDR framework, which guides their processes in developing, manufacturing, marketing, and ensuring the safety of their products. He highlighted the two-year effort invested in navigating this intricate regulatory process, resulting in elevated manufacturing standards and product traceability for their medical software.

The new MDR, effective in Europe since May 2021, represents a significant transformation in the European healthcare regulatory landscape. This certification confirms that Medimaps Group complies with the most rigorous quality standards required to market their products in Europe. It supersedes the 93/42/EEC directive certification, which the company has held for years, affirming its strength and reliability in delivering top-quality products. Through the MDR, Medimaps Group has enhanced the robustness of its clinical assessments, technical designs, and post-market surveillance.

With this certification in place, Medimaps Group can continue to provide its valued customers in Europe and other markets with certified TBS iNsight™ software at the highest standard. TBS iNsight™ is a medical image processing solution seamlessly integrated into dual-energy X-ray absorptiometry (DXA) scanners, X-ray machines, and CT PACs systems. It is used to measure bone mineral density (BMD) for detecting bone fragility in osteoporosis patients. This software offers in-depth bone texture analysis related to bone micro-architecture, enhancing BMD measurements and clinical risk assessment to refine the management of osteoporosis without additional examinations or radiation exposure.

TBS iNsight™ is endorsed in more than 30 medical guidelines globally and has been featured in over 1,000 peer-reviewed scientific articles. It holds CE marking, FDA approval, enabling commercial availability in 60 countries worldwide. In certain countries, it qualifies for reimbursement, including dedicated Current Procedural Terminology (CPT) codes in the USA.

 

Source: businesswire.com

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