FDA clears Biospace med’s new 3D x-ray imaging system


Biospace med has announced that it has received 510(k) clearance from the FDA to market the company’s EOS x-ray imager along with its new image workstation, sterEOS, which enables 3D skeletal reconstruction.

 According to Biospace med, EOS is particularly well-suited for clinical indications such as spine pathologies and hip and knee arthropathies, where a weight-bearing assessment is necessary to ensure optimal treatment. EOS can capture head-to-toe images of patients in a standing, weight-bearing position with a dramatic reduction in radiation dosage – up to ten times less than a conventional x-ray and up to 1000 times less than a computed tomography (CT) scan. Additionally, the new sterEOS 3D reconstruction and measurement workstation is designed to reduce surgical planning time and help establish the most effective course of treatment.

Currently, the only possibility for 3D planning for orthopaedic surgery is a CT scan, which is not reflective of a weight-bearing, functional position of the spine. Using diagnostic images made in the supine position leads to significant changes in relative position of the bones and joints to one another, and ultimately changes the clinical parameters and measurements that are made for preoperative planning purposes, making them potentially inexact.