Medical device maker Pulmera has secured 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its CBeam 3D imaging platform.
CBeam attaches to conventional 2D surgical C-arms via a position-sensor-based system. During a brief rotational scan, the platform captures a series of x-ray images and reconstructs them into a 3D dataset for intraoperative visualization, according to the company.
The device is intended for use in orthopedic and neurological procedures, including imaging of bones, joints, spine, pelvis, and upper and lower extremity fractures, Pulmera said.
