FDA grants 510(k) approval for LineUP multi-extremity weight bearing CT system. CurveBeam,

CurveBeam received FDA 510(k) marketing clearance for its LineUP multi-extremity weight bearing CT system. The system allows radiologists and orthopedic specialists to visualize three-dimensional bone detail of the lower extremities while the patient is standing so they can assess the anatomy in the weight-bearing position.

The LineUP can perform bilateral scans of legs from below the heel to above the knee and accessories enable scanning of hands, wrists and elbows. The system has minimal shielding requirements and the radiation dose to the patient is significantly lower than that of a conventional CT scan. The LineUP recently earned a CE Mark in Europe.

Comment:Weight bearing CT imaging for body extremities became commercially available in 2012. Since then, lower extremity specialists and radiologists have published numerous journal articles on the value of a three-dimensional weight bearing views for conditions ranging from complex hindfoot misalignment to a routine bunion deformity. Published research also suggests a three-dimensional weight bearing view of the knees could be instrumental in early detection of osteoarthritis.

Comment: Unlike conventional CTs, the devices can be placed in smaller spaces, do not require special shielding, and can be plugged into a regular power socket. Moreover, the amount of radiation absorbed by the patient is significantly reduced.