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FDA clears CurveBeam LineUp Multi-extremity weight bearing CT

por John R. Fischer, Senior Reporter | May 18, 2018
LineUp Multi-extremity weight
bearing CT system
Fans of CurveBeam technology can soon look forward to a new tool for assessing lower extremities, following the FDA’s clearance of the enterprise’s LineUp Multi-extremity weight bearing CT system.

Assessing patients while they stand, the compact solution provides users with 3D bone details of the lower extremities at the point-of-care as well as the ability to perform bilateral scans of entire legs, reducing the burden of sending patients to additional departments and enabling treatment to begin sooner.

“If the LineUP is placed at the point-of-care, the specialist could order and obtain a CT scan for the patient during the same visit, rather than the patient having to travel to another department or facility, resulting in a delay of hours, days or even weeks,” Vinti Singh, marketing manager for CurveBeam, told HCB News. “This permits the doctor to discuss the diagnosis and initiate treatment much faster; in addition to preventing multiple copays and deductibles, and in many cases preventing an aggravation of the condition.”

Non-weight-bearing positions can often lead to missed diagnoses of meniscal damage by traditional CT and MR images.

Though plain radiographs can be acquired when patients are in weight-bearing positions, the optimal degree of knee flexion and X-ray beam angulation for quality visualization of joint surface is specific to each individual. The 2D nature of radiographs can prevent accurate detection of joint disease, leading to the occurrence of advanced joint damage.

Three-dimensional weight-bearing is valuable for assessing a range of conditions from complex hindfoot misalignment to routine bunion deformities. It also holds potential for early detection of osteoarthritis.

Using cone beam CT technology, the system projects a wide area X-ray beam onto a flat panel detector to compute 3D volumetric images of the orthopedic extremities.

The use of cone beam CT imaging optimizes the system for high-resolution and high-contrast imaging of osseous structures. Radiation dose is also significantly less than that of conventional CT scanners.

LineUP is equipped with accessories to assess wrists, elbows and hands, has minimal shielding requirements and can be plugged into standard wall outlets.

Singh says the solution is geared toward a variety of providers due to its different capabilities, and could have major impacts on diagnosis, pre-surgical planning and post-surgical evaluations.

“The LineUP is compact, self-shielded, and plugs into a standard wall outlet, and hence, is ideally suited for the point-of-care,” she said. “The LineUP can be implemented in an orthopedic practice or the orthopedic department of a larger institution. Because it offers the unique advantage of a 3D, weight-bearing scan of the bilateral lower extremities, the LineUP would be a valuable addition to any hospital-based radiology department or outpatient imaging center. It could also be used in research labs that focus on biomechanical aspects of the lower extremities.”

CurveBeam recently received FDA clearance for its InReach system for hand, wrist and elbow, which provides specialists the ability to confirm scaphoid fracture diagnosis or distal radius fracture diagnosis at the point-of-care.

A LineUP prototype was first used for research purposes at the University of Iowa. It is currently in use for the same reasons at the University of Kansas.

Both LineUP and InReach are CE-marked. LineUp is also cleared for use in Australia.

The system is now available for sale among U.S. consumers.

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