March 22, 2016 — Olea Medical announced U.S. Food and Drug Administration (FDA) clearance of Olea Sphere 3.0 medical imaging enterprise software package in the United States.
Olea Sphere is an image processing software package intended for picture archive, post-processing and communication. It helps standardize both viewing and analysis capabilities of functional and dynamic imaging datasets acquired with magnetic resonance imaging (MRI) and computed tomography (CT) across vendors. It features innovative image viewing, analysis and processing of most complex MR sequences as well as longitudinal analysis of multiple time points.
Olea Sphere is compliant with the DICOM standard and Windows or Linux operating systems. The software runs on any standard off-the-shelf workstation or it can be used through thin deployment. It maintains the traceability of patient data, through an automatic logout mode, a total connectivity and compatibility with LDAP and Microsoft Active Directory.
New advanced post-processing modules to be introduced on the U.S. market following the FDA clearance are IVIM (Intravoxel Incoherent Motion), Metabolic and Relaxometry. With this clearance, Olea Medical becomes the first manufacturer to provide advanced post-processing for IVIM imaging, integrating their proprietary Bayesian method. IVIM MRI is a powerful feature of diffusion MRI allowing the non-invasive evaluation of blood micro-circulation in tissues without the use of contrast agents.
Prof. Denis Le Bihan, Kyoto University, said, "I am thrilled to see that IVIM MRI, 30 years after its invention, is now available for clinical use. This is another major milestone for diffusion MRI which will extend further its benefits to many patients. I am especially grateful to Olea to have made it possible and proud to collaborate with Olea’s staff on this topic."
For more information: www.olea-medical.com
December 03, 2025 
