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.