09.25.14
EOS Imaging, a developer of 2-D/3-D orthopedic medical imaging, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the latest iteration of the company's sterEOS 3-D imaging software, sterEOS 1.6.
The sterEOS software provides 3-D modeling 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, according to the company. Version 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 aging or scoliotic deformity, company officials said. The new software will be available to existing EOS customers as a software upgrade, and will be included in all new EOS system sales.
The EOS system provides full-body images of patients in a natural standing or seated position in both 2-D and 3-D with 50 to 85 percent less dose than digital radiology and 95 percent less dose than basic computed tomography scans, in accordance with the ALARA (As Low As Reasonably Achievable) principle of radiation reduction.
Marie Meynadier, CEO of EOS imaging, said: “This new generation software release in the U.S. demonstrates our commitment to answer with EOS the medical needs of orthopedic surgeons, among 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 U.S.”
Paris, France-based EOS has facilities in Besançon, France; Cambridge, Mass.; Montreal, Canada; and Frankfurt, Germany. The company also has offices in Singapore.
The sterEOS software provides 3-D modeling 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, according to the company. Version 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 aging or scoliotic deformity, company officials said. The new software will be available to existing EOS customers as a software upgrade, and will be included in all new EOS system sales.
The EOS system provides full-body images of patients in a natural standing or seated position in both 2-D and 3-D with 50 to 85 percent less dose than digital radiology and 95 percent less dose than basic computed tomography scans, in accordance with the ALARA (As Low As Reasonably Achievable) principle of radiation reduction.
Marie Meynadier, CEO of EOS imaging, said: “This new generation software release in the U.S. demonstrates our commitment to answer with EOS the medical needs of orthopedic surgeons, among 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 U.S.”
Paris, France-based EOS has facilities in Besançon, France; Cambridge, Mass.; Montreal, Canada; and Frankfurt, Germany. The company also has offices in Singapore.