Regulatory

Planmed XFI Weight-Bearing CT Scanner Nabs MDR Certification

The scanner is designed to find subtle fractures and misalignments during the first clinic visit.

By: Michael Barbella

Managing Editor

The Planmed XFI imaging system. Photo: Planmed Oy.

Planmed Oy has landed MDR certification for its Planmed XFI imaging system; covering upper and lower extremities as well as head and neck imaging.

Planmed XFI will bring views previously not seen in diagnostic imaging to medical professionals, helping them make an accurate diagnosis, according to the company Planmed XFI is the newest member of the Planmed cone-beam computed tomography (CBCT) family. The scanner is designed to find subtle fractures and misalignments during the first clinic visit. CBCT technology offers insights into conditions that are commonly missed when only using conventional methods, such as 2D radiography.

Planmed XFI is billed as a unique solution to the challenge of detecting problems that are not apparent when the body is at rest, as it provides fast 3D imaging at the point of care. The scanner delivers ultra-high resolution and patient adaptability and can be used for both pre-and postoperative imaging.

“We are excited this low-dose orthopedic imaging system is now available both in the U.S. and in Europe. With the experience that we have from the U.S., we are confident it will be well-received in Europe as well,” Planmed Oy Managing Director Jan Moed stated. “We are very pleased to expand our CT imaging equipment line. Many of our customers in Europe have been looking forward to this certification.”

Planmed XFI will be on display at the ECR – European Radiology Congress in Vienna, March 4–8.

Planmed Oy develops and manufactures advanced imaging equipment and accessories that provide a combination of image quality and ease of use for medical imaging professionals. The company offers products for mammography and orthopedic imaging. Planmed Oy is part of the Finnish Planmeca Group, which consists of several healthcare technology brands, each committed to innovation and design. With 4,400 employees worldwide, Planmeca Group companies achieved a combined turnover of €1.2 billion in 2024.

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