DMS Group Achieves European MDR Certification for STRATOS Densitometers

Diagnostic Medical Systems, specializing in digital radiology and bone densitometry, has obtained EU MDR certification for its STRATOS and STRATOS DR bone densitometers. This compliance confirms adherence to the latest safety, clinical performance, and quality standards. As the sole European bone densitometry equipment manufacturer, DMS Group maintains a unique position against North American and South Korean competitors, achieving €11 million in revenue in 2025 with an 8% growth rate.

Following this achievement, DMS Group has filed a pre-submission with the U.S. FDA for its bone densitometers, aiming to enter the US market, which represents nearly 40% of global demand. The company's radiology solutions have been successful in North America, with regional sales up by 71% in 2025.

In addition, DMS Group is seeking MDR certification for its new ONYX mobile radiology system, which is expected in 2026. This development aligns with the group's strategy to enhance its medical imaging offerings and support healthcare institutions' needs for flexible imaging solutions.