10th Nov 2025 11:04
(Alliance News) - Avingtrans PLC on Monday said its subsidiary Adaptix Ltd has received 510(k) clearance from the US Food & Drug Administration for its 3D orthopaedic X-ray product.
This means the product, Adaptix Ortho350, can move into the human market in the US. Its technology has been commercialised already for veterinary and industrial applications.
Shares in Chatteris, England-based engineering company Avingtrans rose 7.1% to 508.75 pence on Monday morning in London.
It described Ortho350 as a digital tomosynthesis imaging system for hands, elbows, knees and feet offering "fast, lower-cost, 3D X-ray imaging at the point-of-care."
The company suggested that Ortho365 improves on the clarity of 2D imaging systems, and that it works "at a fraction of the radiation dose" seen in traditional X-rays.
Avingtrans Chief Executive Steve McQuillan commented: "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."
Adaptix CEO Sarah Small added: "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."
By Holly Munks, Alliance News reporter
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