CurveBeam Receives FDA Clearance for InReach Cone Beam CT Imaging for Upper Extremities

By Julie A. Vetalice

CurveBeam received FDA 510(k) clearance for InReach, a Cone Beam CT imaging system designed for the hand, wrist/elbow and lower extremities in non-weight bearing positions. The ultra-compact scanner provides high-contrast 3D datasets of bony anatomy that could potentially replace radiographs as a first line of diagnosis. Its small footprint and standard power requirements are ideal features for use by point-of-care facilities.

InReach is supplemented by CubeVue, CurveBeam's custom visualization software that yields multi-planar slices and anatomic 3D renderings, while the Insta-X feature provides Digitally Reconstructed Radiographs, potentially eliminating the need for radiographic exams.

InReach represents the second extremity CT imaging system from CurveBeam, following the pedCAT that launched in 2012. The pedCAT CT system allows for bilateral, true weight bearing imaging of the lower extremities. CurveBeam's pipeline includes the LineUP next generation multi-extremity device, which will provide bilateral weight-bearing images of knees, feet, hand, wrist and elbow. CurveBeam anticipates that LineUP will be submitted for FDA review in early 3Q17.

Source: CurveBeam