CT imaging company CurveBeam revealed on Monday the receipt of the US FDA's 510(k) clearance for its LineUP Multi-extremity weight bearing CT system for launch in the orthopedic extremity imaging market.
The company said the compact system enables radiologists and orthopedic specialists to visualize three-dimensional bone detail of the lower extremities, while the patient is standing, so anatomy can be assessed while in the "weight bearing" or "load bearing" position.
In conjunction, the LineUP can perform bilateral scans of entire legs, the hand, wrist as well as elbow The LineUP system can be plugged into a standard wall outlet and has minimal shielding requirements. Radiation dose to the patient is significantly less than a conventional CT scan.
According to the company, the weight bearing CT imaging for body extremities became commercially available in 2012. The device has been added to the imaging services of numerous hospital foot & ankle sections, orthopedic clinics and podiatry offices worldwide. Its InReach system for hand, wrist and elbow received FDA clearance in 2017. Specialists extol the ability to confirm a scaphoid fracture diagnosis or distal radius fracture diagnosis at the point-of-care.
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