FDA Approves World’s First Weight-Bearing Full-Body Cone-Beam CT Scanner from Planmed

The U.S. Food and Drug Administration (FDA) has granted approval for the world’s first cone-beam CT scannercapable of imaging full-body anatomy in weight-bearing positions, marking a major advancement in orthopedic imaging. The approved device, Planmed XFI, was developed by Planmed, a Finnish company specializing in advanced medical imaging technologies.

Announced Wednesday, the FDA’s clearance allows Planmed XFI to be introduced into U.S. clinical settings, offering unprecedented flexibility in how CT exams are conducted. Unlike traditional CT systems, Planmed XFI allows patients to be scanned while standing, seated, or lying down, which can significantly improve comfort for individuals who have difficulty remaining supine.

The system is designed primarily for orthopedic imaging, where capturing the body under natural, weight-bearing conditions can offer deeper clinical insights. This is especially relevant for evaluating joint spaces, spinal alignment, and biomechanical function—critical data that can help providers make more precise diagnoses and potentially avoid unnecessary surgeries.

“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,” said Jan Moed, managing director of Planmed Oy.

Technically, the scanner features a spacious 85-centimeter opening, a broad field of view, and offers 360-degree imaging. It delivers ultrahigh-resolution 3D scans at up to 75 microns, providing clinicians with clear, precise images for confident decision-making. The system also includes Planmeca’s Ultra Low Dose protocol, enabling diagnostically viable scans with the lowest possible radiation exposure—a key concern in orthopedic and repeat imaging scenarios.

Planmed USA, the company’s U.S. subsidiary, will manage all sales, marketing, and technical support for the new device in the United States. The Planmed XFI will also be featured at the 2025 Radiological Society of North America (RSNA) Annual Meeting, which begins November 30 in Chicago, giving clinicians and imaging professionals an early look at this breakthrough technology.

With FDA approval secured, Planmed XFI is positioned to fill a key gap in orthopedic diagnostics, providing a more natural and versatile imaging experience that may redefine how musculoskeletal conditions are assessed and treated.