CurveBeam Gains CE Mark for Specialized Extremity Imaging

By Julie A. Vetalice

CurveBeam received CE Mark approval for LineUP and InReach orthopaedic extremity CT imaging systems.

The compact systems require minimal shielding and minimize patient exposure to radiation, and can be plugged into a standard wall outlet—an ideal feature for point-of-care facilities.

LineUP supports scans with the patient in weight bearing position and can perform bilateral scans of the entire leg; further, an adaptive chair can be used to scan the hand, wrist and elbow. InReach is designed for hand, wrist and elbow in non-load bearing positions.

InReach received FDA 510(k) clearance in 2017. The company's pedCAT system for bilateral weight bearing scans of the foot and ankle received FDA clearance in 2012.

Sources: CurveBeam; ORTHOWORLD Inc.

CurveBeam LineUP Extremity CT System

CurveBeam LineUP. Image courtesy of CurveBeam.

Product Labels: Shoulder Replacement, Elbow/Radial Head Replacement, Finger/Hand/Wrist Replacement, Knee Replacement, Ankle Replacement

Tags: CE Mark, Regulatory