CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System

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CurveBeam announced it has received FDA 510(k) clearance for its LineUP Multi-extremity weight bearing CT system.

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. The LineUP can perform bilateral scans of entire legs, from below the heel to above the knee. Accessories permit scanning of the hand, wrist and elbow as well.

“CurveBeam continues to elevate the standard of care for orthopedic extremity imaging, and introduction of  the LineUP device is another solid step upwards,” CurveBeam President & CEO Arun Singh said. “The LineUP is best-in-class for field of view dimensions and image quality. Coupled with CurveBeam’s exemplary customer support and service, the LineUP is poised to revolutionize orthopedic care.”

The LineUP system can be plugged into a standard wall outlet and has minimal shielding requirements. Radiation dose to the patient is also significantly less than a conventional CT scan.

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

CurveBeam was founded in 2009 and is privately owned and operated. CurveBeam’s corporate office is located in Warrington, Pennsylvania.

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