Shares in Avingtrans PLC (AIM:AVG) jumped 8% to 514.5p after its medical imaging subsidiary Adaptix Limited secured FDA 510(k) clearance for its Ortho350 orthopaedic imaging system, a key step towards commercial rollout in the United States.
The Adaptix Ortho350 is a compact, mobile 3D Digital Tomosynthesis (DT) device designed to provide rapid, low-cost and low-dose 3D X-ray imaging at the point of care.
Targeted at orthopaedic applications for the hands, elbows, knees and feet, it delivers significantly lower radiation exposure than traditional CT scans while offering higher image clarity than conventional 2D X-rays.
The system aims to enhance diagnostic accuracy and efficiency in clinical environments such as primary care, intensive care and emergency departments.
Adaptix has already commercialised its DT technology for veterinary and industrial applications, with the FDA clearance marking its formal entry into the human healthcare market.
Sarah Small, Adaptix’s chief executive, said the clearance represented “a pivotal moment” for the business, citing strong early interest from healthcare providers.
Steve McQuillan, chief executive of Avingtrans, described the approval as a “major regulatory milestone” that validates Adaptix’s technology and opens the door to the substantial US orthopaedic imaging market.
Avingtrans, which supplies advanced systems and components across the energy, medical and industrial sectors, said the development underscores its strategy of backing innovative technologies with strong commercial potential.