REG - Avingtrans PLC - Adaptix receives FDA 510(K) clearance

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RNS Number : 7459G  Avingtrans PLC  10 November 2025

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:

 

 Avingtrans plc                                          01354 692 391
 Roger McDowell, Chairman

 Steve McQuillan, Chief Executive Officer

 Stephen King, Chief Financial Officer

 Singer Capital Markets (Nominated Adviser and Broker)   020 7496 3000
 Sara Hale

 Alex Bond

 Oliver Platts

 IFC Advisory (Financial PR)                             020 3934 6630
 Graham Herring

 Tim Metcalfe

 Zach Cohen

 

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

 

 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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