CurveBeam Announces FDA 510(k) Clearance for LineUP Weight Bearing Multi-Extremity CT System
WARRINGTON, Pa., May 14, 2018 /PRNewswire/ -- 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 & 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.
Traditional CT and MR images are acquired in a non-weight bearing position, leading to "missed diagnoses of meniscal damage," according to Dr. Neil Segal, MD, MS, who has been overseeing research efforts using a LineUP prototype, first at the University of Iowa and currently at the University of Kansas.
Although plain radiographs can be acquired while the patient is in a full weight-bearing position, the optimal degree of knee flexion and X-Ray beam angulation to best visualize the joint surface is person specific.
"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. Segal said.
CurveBeam introduced the pedCAT system, which permits bilateral weight bearing scans of the feet and ankles in 2012. Since then, the device has been added to the imaging services of numerous hospital foot & ankle sections, orthopedic clinics and podiatry offices worldwide.
CurveBeam's 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.
CurveBeam designs and manufactures Cone Beam CT imaging equipment for the orthopedic and podiatric specialties. CurveBeam was founded in 2009 and is privately owned and operated. CurveBeam's corporate office is located in Warrington, Pennsylvania, USA.
CONTACT: Vinti Singh, email@example.com
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