Planmed XFI® weight-bearing CT scanner receives CE MDR certification

Planmed Oy, a leading provider of advanced medical imaging solutions, is proud to announce that its Planmed XFI® imaging system has successfully obtained CE marking under the EU Medical Device Regulation (MDR), with certification covering upper and lower extremities as well as head and neck imaging.

This milestone underscores Planmed’s commitment to delivering safe, effective, and innovative diagnostic tools in accordance with the strict requirements of the EU MDR (2017/745).

The Finnish medical imaging company Planmed is pleased to introduce and bring Planmed XFI® to the European market. Planmed XFI will bring views previously not seen in diagnostic imaging to the disposal of medical professionals, helping them in their most important task – making an accurate diagnosis.

Planmed XFI is the newest member of the renowned Planmed cone-beam computed tomography (CBCT) family. The scanner has been designed to find subtle fractures and misalignments during the first visit to the clinic. CBCT technology offers insights into conditions that are commonly missed when only using conventional methods, such as 2D radiography.

Planmed XFI is a unique solution to the challenge of detecting problems that are not apparent when the body is at rest; 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 that this innovative, low dose orthopedic imaging system is now available both in the U.S. and in Europe. With the experience that we have from the USA, we are confident that it will be well-received in Europe as well,” states Jan Moed, Managing Director of Planmed Oy.

Planmed’s products are well-known for their exquisite design, user ergonomics, and image quality. “We are very pleased to expand our CT imaging equipment line. Many of our customers in Europe have been looking forward to this certification,” continues Moed.

Planmed XFI will be on display at the ECR – European Radiology Congress in Vienna, March 4–8, 2026.