May 12, 2025 - 8:00 AM - Diagnostic Medical Systems (Euronext Growth Paris: FR0012202497 - ALDMS et FR001400IAQ8 - DMSBS), a specialist in high-performance medical imaging systems for Digital Radiology and Bone Densitometry, announces that it has obtained FDA (Food and Drug Administration) clearance for the commercialization of the !M1 mobile radiology solution in the U.S. market.
This decisive regulatory milestone follows the strategic agreement signed with Medlink Imaging, a subsidiary of the listed Korean company Vieworks, for the distribution of the !M1 in the United States (PR 06/11/2024). Effective immediately, Medlink Imaging is initiating first deliveries across the U.S., leveraging its nationwide distribution network and the integration of Vieworks detectors within the !M1 system.
Samuel SANCERNI, Chairman and CEO of DMS Group, commented:
"The FDA clearance represents a major strategic milestone for our Group. It confirms our ambition to accelerate international expansion, particularly in the U.S.-the world's most dynamic market for mobile Radiology. The immediate start of commercialization with our partner Medlink Imaging marks a new chapter for the !M1 system. This milestone also highlights and validates the strategic relevance of our acquisition of Solutions for Tomorrow, whose technological excellence is now a key growth lever for DMS Group."
A STRATEGIC AND HIGH-POTENTIAL MARKET
The U.S. market represents more than 1,200 mobile radiology units sold annually. FDA clearance therefore opens the door to significant commercial potential for DMS Group, which aims to establish itself as a leading player in this segment.
The !M1 solution, developed by SFT (Solutions for Tomorrow), stands out for:
- its mobility,
- compactness,
- clinical performance,
- and adaptability to the most demanding hospital environments.
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ABOUT DMS GROUP
The DMS Group is a French manufacturer of digital radiology solutions with an international focus, recognized as a key player and essential partner in the value chain due to the quality of its solutions, flexibility, ingenuity, and responsible values.
In 2024, the DMS Group achieved consolidated revenue of €46.1 million, with 75% generated internationally, and has a presence on all continents through a network of over 140 national distributors.
The DMS Group is listed on the Euronext Growth Paris market (ISIN: FR0012202497 - Ticker: ALDMS) and is eligible for the PEA-PME Investment plan.
On June 13, 2023, the DMS Group issued Warrants (BSA) listed on the Euronext Growth Paris market (ISIN: FR001400IAQ8 - Ticker: DMSBS), exercisable until September 12, 2025.
The DMS Group is part of the ETIncelles program, supporting SMEs aiming to scale into mid-cap companies.
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CONTACTS
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Press Relations
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https://www.actusnews.com/documents_communiques/ACTUS-0-91610-cp_12_05_2025_dms-group_clearance_commerzialisation_m1_en.pdf
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