Medical imaging device developer CurveBeam said today it won FDA 510(k) clearance for its LineUp multi-extremity weight bearing computed tomography system.
The newly cleared system is designed for the 3D visualization of bone detail in the lower extremities while the patient remains standing so that the anatomy can be assessed while in load bearing positions, the Warrington, Penn.-based company said. The device can perform bilateral scans of entire legs, from below the heel to above the knee, CurveBeam said.
“Difficulty in reproducing the same view of the joint over time impairs ability to detect joint disease, and the 2D nature of radiographs makes these images of overlapping bony anatomy very insensitive for detecting abnormalities until there is advanced joint damage,” Dr. Neil Segal of the University of Kansas, who oversaw research using a LineUP prototype, said in a prepared statement.
CurveBeam said that it introduced the PedCat system which allowed for bilateral weight bearing scans of feet and ankles in 2012, and has added to imaging services for foot and ankle sections since. The company’s Inreach system for hand, wrist and elbows received FDA clearance last year.
“CurveBeam continues to elevate the standard of care for orthopedic extremity imaging, and introduction of the LineUP device is another solid step upwards. The LineUP is best-in-class for field of view dimensions and image quality. Coupled with CurveBeam’s exemplary customer support & service, the LineUP is poised to revolutionize orthopedic care,” prez & CEO Arun Singh said in a press release.
Last mont, CurveBeam said it won CE Mark approval in the European Union for its LineUP and InReach orthopedic extremity CT scanning systems.