FDA clears software dedicated to sagittal balance and posture analysis


EOS imaging has announced that its next-generation sterEOS 3D imaging software, sterEOS 1.6, has received 510(k) clearance from the US Food and Drug Administration (FDA).

The sterEOS software provides 3D modelling of the spine and lower limbs based on scans taken with the EOS System, and automatically calculates more than 100 clinical parameters relevant to diagnosis and surgical planning. The new sterEOS 1.6 integrates a postural assessment feature dedicated to spine pathologies and associated surgeries that allows a fast analysis of a patient’s skeletal balance and helps the surgeon plan adequate spinal surgery to maintain or restore this balance, which is often modified or lost with ageing or scoliotic deformity. The new software will be made available to existing EOS customers as a software upgrade and will be included in all new EOS system sales.


Concurrent with the FDA clearance, the benefits of EOS and its software sterEOS were highlighted at the 49th Annual Meeting of the Scoliosis Research Society (SRS; 10–13 September, Anchorage, Alaska, USA) and during an associated EOS educational symposium that gathered more than 50 surgeons from all around the world.


The symposium, titled “Innovations in sagittal balance for scoliosis treatment” featured presentations from four leading orthopaedic surgeons from the United States and France. Additionally, medical communications by EOS users during the SRS congress also highlighted the importance of sagittal balance as well as the value of 3D visualisation in prognostic and surgical planning.


The EOS system provides full-body images of patients in a natural standing or seated position in both 2D and 3D with 50% to 85% less dose than Digital Radiology and 95% less dose than basic CT scans, in accordance with the ALARA (As Low As Reasonably Achievable) principle of radiation reduction.


Marie Meynadier, CEO of EOS imaging, says, “This new generation software release in the USA demonstrates our commitment to answer with EOS the medical needs of orthopaedic surgeons, amongst whom EOS users have widely contributed to a general recognition of the importance of global patient assessment and sagittal balance analysis in spine care. By continuously enhancing the capabilities of the EOS platform in support of our customers, we keep encouraging adoption by medical facilities throughout the USA.”