Nov.10, 2025 — Medical imaging expertise firm Adaptix Ltd. has obtained 510(okay) clearance from the U.S. Meals and Drug Administration for its orthopedic 3D imaging product, the Adaptix Ortho350.
Based mostly within the Oxford College Science Park in the UK, Adaptix is on a mission to remodel radiology by providing inexpensive, low-dose 3D Digital Tomosynthesis (DT) imaging on the point-of-care.
The brand new Adaptix Ortho350 is a compact, cell, low-dose DT orthopedic imaging system able to delivering quick, lower-cost, 3D X-ray imaging on the point-of-care. Developed particularly to supply 3D X-ray imaging of higher and decrease extremities; arms, elbows, knees and ft, at a fraction of the radiation dose of conventional CT techniques. The Adaptix Ortho350 system supplies clinicians with clearer photos than 2D X-ray techniques, providing benefits when it comes to fewer acquisitions, accelerated affected person workflow and enhanced diagnostic accuracy.
Adaptix is already serving veterinary and industrial markets utilizing its revolutionary expertise within the type of the Adaptix VetSA3D veterinary imaging product and the Adaptix NDT3D industrial Non-Damaging Check merchandise. Receiving the FDA 510(okay) clearance will open up the human imaging marketplace for its expertise within the US and permit Adaptix to ship on its mission to remodel radiology by provision of revolutionary 3D imaging applied sciences into healthcare suppliers.
Sarah Small, Adaptix’s CEO, acknowledged, “Securing this FDA 510(okay) clearance represents a big milestone for Adaptix in our mission to remodel radiology. We have already got an excessive amount of curiosity from healthcare suppliers and clinicians for our revolutionary orthopedic imaging system. We’re wanting ahead to delivering “3D-First” enhanced orthopedic DT imaging throughout Main Care, Intensive Care and Emergency Departments all through the US and past.”
Extra data is accessible at www.adaptix.com.
