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10/06/2026 17:45
DMS GROUP OBTAINS MARKETING AUTHORIZATION FOR ITS NEW ONYX RADIOLOGY MOBILEDMS GROUP OBTAINS MARKETING AUTHORIZATION FOR ITS NEW ONYX RADIOLOGY MOBILE
June 10, 2026 – 5:45 pm – Diagnostic Medical Systems (Euronext Growth Paris: FR0012202497 – ALDMS), a specialist in high-performance medical imaging systems for digital radiology and bone densitometry, is pleased to announce that it has obtained MDR (Medical Device Regulation) certification for its new ONYX mobile radiology system, paving the way for its commercialization on the European market. This approval, issued under the new European Medical Device Regulation, now authorizes the marketing of ONYX on the European market and marks a structuring step in DMS Group's development strategy. First deliveries of equipment are expected in Q3 2026.
A NEW STEP IN DMS GROUP'S MOVE UPMARKET WITH A TECHNOLOGICAL PLATFORM AT THE SERVICE OF HOSPITAL MOBILITY Designed to meet the growing mobility and flexibility needs of healthcare facilities, ONYX combines compactness, maneuverability, and advanced imaging performance. The system includes:
With its compact design and high mobility, ONYX meets the operational requirements of the most demanding hospital environments, including intensive care, emergency or mobile units. In addition to its clinical performance, ONYX is also an innovation with a strong economic impact for healthcare institutions thanks to:
Obtaining this MDR certification confirms DMS Group's ability to develop and industrialize innovative technological solutions that meet the most demanding regulatory standards. It also illustrates the move upmarket of the Group's product portfolio and its ambition to position itself sustainably among the leading technological players in digital medical imaging.
DMS GROUP: A GROWTH DYNAMIC SUPPORTED BY INNOVATION Winner of the 2024 Innovation Prize, awarded by the French Society of Radiology (SFR), ONYX illustrates DMS Group's innovation strategy and its ambition to offer differentiating solutions with high technological added value. Its development is part of DMS Group's MC2 project, which aims to develop new high-end imaging solutions, manufactured in France. The MC2 project benefits from funding from the French government as part of the Recovery Plan for Industry - Strategic Sectors, and the Investments for the Future Program (PIA). Beyond its own commercial networks, DMS Group also plans to offer ONYX to several industrial partners in white label collaborations, thus strengthening its positioning as a key player in the global medical imaging value chain. With the commercial launch of ONYX, DMS Group is strengthening its radiology offering and supporting its international growth dynamic. The Group thus confirms its desire to accelerate the deployment of innovative solutions with high technological value in its strategic markets. DMS Group confirms its strategy based on innovation, internationalization and the increase in value of its product offering. The Group intends to capitalize on the commercial launch of ONYX to accelerate its development in priority markets and continue to gradually improve its growth and profitability profile.
Samuel Sancerni, Chairman and Chief Executive Officer of DMS Group, comments: "Obtaining MDR certification for ONYX is a major milestone for DMS Group. This launch is the culmination of several years of investment in R&D around a particularly innovative and differentiating platform. ONYX has strong technological and commercial assets that allow us to address a dynamic and buoyant global market. With ONYX, we offer a new generation of equipment combining mobility, ergonomics, software intelligence and AI, fully meeting the new expectations of healthcare institutions. This new generation of mobile radiology is therefore an important lever for growth and value creation for the Group in the years to come.”
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