FDA clears world's first upright cone-beam CT scanner

The U.S. Food and Drug Administration has just approved the world’s first cone-beam weight-bearing CT scanner. 

Planmed, a Finnish company that specializes in medical imaging solutions, announced the approval of Planmed XFI on Wednesday. The full-body scanner enables patients to complete their exams either standing or in a supine position, offering increased flexibility for those who may struggle to lay on their back. 

The scanner is intended for use in orthopedics, where weight-bearing imaging can make a significant difference in diagnosis and treatment. Makers of XFI say the system will help providers make more informed decisions regarding patient management. This could potentially prevent some patients from undergoing unnecessary surgery. 

The system has a wide 85-centimeter opening and a broad field; it offers a 360-degree view of anatomy, resulting in ultrahigh-resolution 3D images up to 75 microns. It comes with the Planmeca Ultra Low Dose protocol software already integrated, ensuring exams are completed using the lowest radiation dose that is diagnostically feasible. 

“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,” Jan Moed, managing director of Planmed Oy, said in an announcement on the approval. 

Planmed’s U.S. subsidiary, Planmed USA, will be handling sales, marketing and tech support stateside. The scanner will be on display at this year’s Radiological Society of North America Annual Meeting starting on Nov. 30 in Chicago.