biospace med receives FDA 510(k) clearance for sterEOS 2D/3D workstation for pediatric use in spine applications

Mar 8 2010

biospace med (www.biospacemed.com) announced today that it has received 510(k) clearance from the FDA (Food and Drug Administration) to market the Company’s sterEOS 2D/3D workstation for pediatric use in spine applications. The Company’s EOS ultra-low-dose imager previously has been FDA-cleared for use in pediatrics and adults, while sterEOS has previously been FDA-cleared for adult use in spine.

“With this latest FDA clearance, we are establishing the ultra-low-dose EOS imager and its 3D bone-modeling sterEOS workstation as standard of care in the imaging of both pediatric and adult populations for all orthopedic indications that require a true weight-bearing assessment to ensure the best possible treatment-planning”

EOS can capture head-to-toe images of children and adults in a standing, weight-bearing position with a dramatic reduction in radiation dosage—up to 10 times less than a conventional x-ray and up to 1000 times less than a CT (Computed Tomography) scan. And, the full-length, weight-bearing imaging capabilities of EOS provide physicians with a global vision of balance and posture. Now, with additional 3D bone-modeling made possible by sterEOS, the relative positions of each vertebra are established, thereby enabling better preoperative and postoperative assessment for surgical-planning purposes.

“FDA clearance for sterEOS pediatric use in spine will have a significant impact on demand for EOS, as it will allow for the first time to visualize in 3D the spine deformations in the standing, weight-bearing position and retrieve fundamental clinical parameters for surgical planning. This is all done at a drastically reduced radiation exposure and enables repeat exams for a better follow-up from childhood to adulthood,” said Peter Newton, M.D., Rady Children’s Hospital, San Diego. “Reduction of radiation exposure is especially important for children and adolescents who have scoliosis or other types of musculoskeletal disorders that are being followed on a frequent basis and therefore need to have regular x-rays over a long period of time in order to watch the progression of their condition and treatment. A technology that can reduce radiation exposure up to 10 times compared to a conventional x-ray and up to 100 or more times compared to a CT scan is a major breakthrough for orthopedic imaging—especially for the pediatric population.”

“With this latest FDA clearance, we are establishing the ultra-low-dose EOS imager and its 3D bone-modeling sterEOS workstation as standard of care in the imaging of both pediatric and adult populations for all orthopedic indications that require a true weight-bearing assessment to ensure the best possible treatment-planning,” added Marie Meynadier, Ph.D., chief executive officer of biospace med.