CurveBeam Gains CE Mark Approval for HiRise Weight-Bearing CT System for Lower Extremities

By Julie A. Vetalice

CurveBeam Gains CE Mark Approval for HiRise Weight-Bearing CT System for Lower Extremities

HiRise, the lower extremity weight-bearing CT imaging system from CurveBeam, gained approval under the CE Mark. FDA 510(k) clearance is expected in 4Q20.

CurveBeam markets the only systems that feature a wide platform that lets patients stand naturally on both feet during a scan. HiRise can scan anywhere along the lower extremity, from the hip/pelvis to the feet. Further, weight-bearing CT imaging of the hip and pelvis is not available in any other system.

The HiRise gantry tilts for upper extremity imaging and supine lower leg imaging.

CurveBeam’s systems utilize cone beam CT technology and are designed for orthopedic point-of-care settings. The HiRise plugs into a standard wall outlet, requires minimal shielding and is easy to operate.

CurveBeam also offers the weight-bearing pedCAT CT imaging system for the foot and ankle, LineUP for foot, knee and upper extremity and InReach for hand, wrist, elbow and lower extremities.

“At CurveBeam, we lead through innovation, driven by the clinical needs and research initiatives of our customers” said Director of European Affairs Guy Long. “In less than a decade after we introduced our first weight bearing CT system for foot & ankle, we are now launching our third-generation device which extends this groundbreaking technology to the hip.”

 

Product Labels: Lower Extremity

Tags: CE Mark, Regulatory