CurveBeam’s Weight-Bearing CT System Gets FDA Clearance

CurveBeam has obtained FDA 510(k) clearance for HiRise, a weight-bearing computed tomography (CT) imaging system.

The device is cleared for imaging the entire lower extremity and allows patients to stand naturally on their feet during a scan. It can tilt to conduct scans for the upper extremity and supine lower leg imaging.

HiRise is able to scan anywhere along a patient’s lower extremity, from the hip and pelvis to the feet, and is the first system able to conduct weight-bearing CT scans of the hip and pelvis, the company said. The device was granted the CE mark in October.