DMS GROUP OBTAINS MARKETING AUTHORIZATION FOR ITS NEW ONYX RADIOLOGY MOBILE

10 Jun 2026 17:45 CEST

DMS GROUP OBTAINS MARKETING AUTHORIZATION FOR ITS NEW ONYX RADIOLOGY MOBILE

• Obtaining certification under the European Medical Device Regulation (MDR)

• Commercial launch of ONYX, a new generation of ultra-mobile and intelligent radiology mobile

• First deliveries expected in Q3 2026

• DMS Group strengthens its position in the global mobile radiology market

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:

• a next-generation X-ray tube based on carbon nanotube (CNT) technology, enabling miniaturization and significant reduction in system weight;
• a "zero gravity" arm offering precise and effortless positioning;
• an X-Tech Cell® lithium-ion battery for extended battery life and ultra-fast charging;
• the artificial intelligence features of the ADAM software, optimizing image quality and dose reduction.

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:

• Reduced maintenance costs;
• Better operational continuity;
• Extended life of critical components;
• Workflow optimization.

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.”

UPCOMING EVENTS^* :

• 15/06/2026 General Assembly
• 20/07/2026 Q2 2026 revenue
• 28/09/2026 2026 half-year results

The publications will take place after the close of the Euronext market in Paris.
*Provisional schedule subject to change. Visit the DMS Group website.

Find financial information on our investor area: www.dms.com

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ABOUT DMS GROUP
DMS Group is a French digital radiology manufacturer, internationally oriented, recognized as a key player and a key partner in the value chain, both for the quality of its solutions, and for its flexibility, ingenuity and responsible values.
In 2025, DMS Group achieved a consolidated revenue of €50 million, of which more than 75% was international, with a presence on all continents through a network of more than 140 national distributors.
DMS Group is listed on the Euronext Growth Paris market (ISIN: FR0012202497 - ticker: ALDMS) and is eligible for the PEA PME-ETI.
DMS Group is part of the ETIncelles program for SMEs that have the ambition and the desire to become mid-caps.

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