Revolutionizing Diagnostic Imaging: Planmed XFI® Receives FDA Clearance

In a landmark development for medical imaging, the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to the Planmed XFI® full-body cone-beam computed tomography (CBCT) scanner.

This breakthrough, announced on September 26, 2025, marks the arrival of the world’s first CBCT system capable of imaging the entire human body in upright, supine, or seated positions.

Developed by Finnish imaging innovator Planmed, the XFI system introduces a paradigm shift in orthopedic and trauma diagnostics.

Unlike conventional CT or 2D radiography, Planmed XFI allows clinicians to visualize anatomical structures under natural load—offering unprecedented insight into subtle fractures, joint misalignments, and dynamic pathologies that often elude traditional imaging.

Key Features of Planmed XFI®:

  • Full-body imaging in standing, seated, and lying positions
  • Cone-beam CT technology for ultra-high resolution 3D scans
  • Rapid point-of-care imaging for both pre- and postoperative assessments
  • Enhanced detection of conditions missed by 2D radiographs
  • Designed for orthopedic, trauma, and musculoskeletal applications

Jan Moed, Managing Director of Planmed Oy, emphasized the scanner’s versatility:

“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.”

The system’s ergonomic design and adaptability are expected to resonate with clinicians across North America, where Planmed USA, Inc. (Charlotte, NC) will oversee distribution and support.

Upcoming Showcase’s :


Planmed XFI will be unveiled at the RSNA Annual Meeting in Chicago, IL, starting November 30, 2025—offering attendees a firsthand look at this transformative technology.

Dr Sai Kiran
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