Adaptix receives FDA 510(K) clearance
We are pleased to announce that our 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.”
