Versatile Full-Body Cone-Beam CT Scanner Gets FDA Clearance

Offering a combination of enhanced image resolution and adaptability with patient positioning, the Planmed XFI cone-beam CT (CBCT) device has received 510(k) clearance from the Food and Drug Administration (FDA).

The full-body weightbearing Planmed XFI is currently the only CBCT device allow upright and supine patient positioning, according to Planmed, the manufacturer of the device.

Providing ultra-high resolution and 3D imaging capability at the point of care, the company said the Planmed XFI device is particularly adept at detecting subtle fractures and misalignments.

“Planmed XFI is the first and only full-body CT system in the world that can image seated, supine, and standing patients. We are excited that this innovative, low-dose orthopedic imaging system is now available in the U.S. We are confident that it will be well received,” stated Jan Moed, the managing director of Planmed Oy.