Adaptix, based at Oxford University Science Park, has now received 510(k) clearance from the US Food and Drug Administration, an important milestone that demonstrates that Adaptix’s device is safe, effective and marketable in the US.
Adaptix is transforming radiology through the development of innovative 3D imaging technologies. The first Adaptix medical product is a Digital Tomosynthesis Orthopedic imaging system. It is a portable, low-dose imaging system capable of delivering fast, lower-cost X-ray imaging at the point of patient care. It was developed specifically to offer 3D X-ray imaging of hands, elbows and feet at a fraction of the radiation dose and per-study price of traditional CT scanning systems.
Now that Adaptix has received 510(k) clearance, its technology can be marketed in the world’s largest healthcare market.