FDA clears biospace med's sterEOS 2D/3D workstation for pediatric use in spine
“The EOS ultra-low-dose imager along with the sterEOS 3D workstation is a major advance for pediatric imaging because it dramatically reduces radiation exposure for children and adolescents while also making possible the first weight-bearing 3D images for better surgical planning.” Peter Newton, M.D. Rady Children’s Hospital, San Diego
CAMBRIDGE,
Mass. & PARIS-(BUSINESS WIRE)-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.
About biospace med
biospace med was founded on a unique partnership between Nobel Prize-winning physicist Georges Charpak, Ph.D., and a team of biomedical engineers, orthopedic surgeons and radiologists who developed a complete orthopedic imaging solution. The Company’s lead product, EOS ultra-low-dose 2D/3D imager, allows full-body imaging of patients in a weight-bearing position that enables global assessment of balance and posture. The sterEOS workstation enables 3D bone-envelope-modeling in a weight-bearing position and provides over 100 clinical parameters to the orthopedic surgeon for pre- and post-operative surgical planning. EOS and sterEOS offer a total solution in orthopedic imaging now available in the U.S. since receiving FDA 510(k) clearance. The Company has corporate headquarters in Cambridge, Mass. (185 Alewife Brook Parkway, Suite 410; toll-free: +1-866-933-5301), and Paris, as well as an office in Montreal, and is targeting a $2 billion orthopedic imaging marketplace.