Adaptix receives FDA 510(K) clearance
Summary by AI BETAClose X
10 November 2025
Avingtrans plc
("Avingtrans", the "Company", or the "Group")
Adaptix receives FDA 510(K) clearance
Avingtrans plc (AIM: AVG), which designs, manufactures and supplies critical components, modules, systems and associated services to the energy, medical and industrial sectors, is pleased to announce that its subsidiary Adaptix Limited ("Adaptix") has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for its orthopaedic 3D imaging product, the Adaptix Ortho350.
Adaptix is developing affordable, low-dose 3D Digital Tomosynthesis (DT) imaging systems designed for point-of-care use. The newly cleared Adaptix Ortho350 is a compact, mobile, low-dose DT orthopedic imaging system capable of providing fast, lower-cost, 3D X-ray imaging at the point-of-care. It is designed specifically for upper and lower extremity imaging (hands, elbows, knees and feet) at a fraction of the radiation dose associated with traditional CT systems. The Ortho350 delivers superior image clarity compared with 2D X-ray systems, improving diagnostic accuracy, workflow efficiency and patient outcomes.
Adaptix has already successfully commercialised its core technology in veterinary and industrial markets through the Adaptix VetSA3D and Adaptix NDT3D systems, respectively. The FDA 510(k) clearance now enables Adaptix to enter the human healthcare imaging market in the United States, marking a major milestone in its mission to transform radiology.
Sarah Small, CEO of Adaptix, commented: "Securing FDA 510(k) clearance represents a major achievement for Adaptix and a pivotal moment in our mission to transform radiology. We are excited by the strong interest we have already received from healthcare providers and clinicians for our revolutionary orthopaedic imaging system. The Adaptix Ortho350 will enable '3D-First' imaging in Primary Care, Intensive Care, and Emergency Departments across the US and beyond."
Steve McQuillan, CEO of Avingtrans plc, added: "We are delighted with this important regulatory milestone for Adaptix. This clearance opens the door for entry into the substantial US orthopaedic imaging market and validates the commercial potential of Adaptix's technology. This achievement represents another significant step forward for Adaptix."
Enquiries:
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Avingtrans plc |
01354 692 391 |
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Roger McDowell, Chairman Steve McQuillan, Chief Executive Officer Stephen King, Chief Financial Officer
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Singer Capital Markets (Nominated Adviser and Broker) |
020 7496 3000 |
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Sara Hale Alex Bond Oliver Platts |
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IFC Advisory (Financial PR) |
020 3934 6630 |
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Graham Herring Tim Metcalfe Zach Cohen |
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About Avingtrans plc:
Avingtrans designs, manufactures and supplies original equipment, systems and associated aftermarket services to the energy, medical and industrial markets worldwide.
Business units
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Hayward Tyler - Luton, East Kilbride UK, USA, China and India Specialises in the design, manufacture and servicing of performance-critical motors and pumps for challenging environments. Energy Steel, Inc - Rochester Hills, Michigan, USA Provider of custom fabrications for the nuclear industry, specialising in: OEM parts obsolescence; custom fabrications; engineering design solutions; product refurbishment; on-site technical support. Stainless Metalcraft Ltd - Chatteris, UK Provider of safety-critical equipment for the energy, medical, science and research communities, worldwide, specialising in precision pressure and vacuum vessels and associated fabrications, sub-assemblies and systems. Booth Industries - Bolton, UK Designs, manufactures, installs and services doors and walls which can be tailored to be: blast and explosion proof; fireproof; acoustically shielded; high security/safety; or combinations of the above. Ormandy Group - Bradford, UK Design, manufacturers and servicing of off-site plant, heat exchangers and other HVAC (heating, ventilation and air conditioning) products. Slack & Parr - Kegworth, UK, USA & China Design, manufacture and servicing of high-precision gear metering pumps, hydraulics flow dividers and industrial pumps. Composite Products Ltd - Buckingham, UK Centre for composite technology, parts and assemblies, serving customers in industrial markets. Adaptix Ltd - Oxford, UK Adaptix has developed novel 3D X-ray for Orthopaedic and Veterinary applications amongst others. Commercialisation of this system (and others) is on-going. Magnetica Ltd - Brisbane, Australia Magnetica Limited specialises in the development of next generation MRI technologies, including dedicated extremity MRI systems and MRI system components. Magnetica has successfully built and tested a compact, integrated 3 Tesla orthopaedic MRI system, demonstrating clinical-quality imaging. Commercialisation of this system (and others) is on-going. Magnetica's structure now includes two other business units: Scientific Magnetics - Abingdon, UK Designs and manufactures superconducting magnet systems and associated cryogenics for a variety of markets including MRI and provides services for Nuclear Magnetic Resonance instruments. Tecmag Inc - Houston, USA Designs, manufactures and installs instrumentation, including consoles, system upgrades, and probes, mainly for Magnetic Resonance Imaging (MRI) and Nuclear Magnetic Resonance (NMR) systems. |
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