DMS Group Targets the American Market Following European MDR Certification
DMS Group announces the acquisition of the MDR (Medical Device Regulation) certification for its entire range of STRATOS and STRATOS DR bone densitometers. This compliance with the latest European regulatory standards is part of the French group's international expansion strategy, specializing in medical imaging systems.
Achievement of MDR Certification
The group has obtained the MDR certification, which replaces the MDD Directive that has been in effect for 25 years. This certification confirms the compliance of the osteodensitometry solutions with the most demanding European standards in terms of safety, clinical performance, and quality. It represents a significant milestone in the execution of DMS Group's regulatory roadmap and ensures the continued marketing of its systems in the European market. DMS Group remains the only European manufacturer of osteodensitometry equipment, competing against two North American players and one South Korean player.
Expansion into the US Market
Following this certification, DMS Group recently submitted a pre-submission file to the Food & Drug Administration (FDA) in the United States for its bone densitometers. This preliminary step aims to initiate discussions with the American authority in anticipation of the future submission of the registration dossier. The United States accounts for about 40% of the global osteodensitometry market, a market in which DMS Group is not currently present with its range of bone densitometers. Concurrently, the group continues regulatory procedures related to its new mobile radiology system ONYX, with MDR certification expected in the second quarter of 2026. With this new platform, DMS Group intends to strengthen its medical imaging offerings and meet the evolving needs of healthcare facilities in terms of mobility and flexibility.
