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Olea Medical Receives FDA Clearance for Olea Sphere 3.0

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March 21, 2016: Olea Medical, a provider of advanced MR and CT perfusion imaging post-processing announces FDA clearance of Olea Sphere® 3.0 medical imaging enterprise software package in the US.

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 MRI and 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. Olea Sphere® 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 US 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 of evaluation blood micro-circulation in tissues without the use of contrast agents.

"The FDA clearance of this new version of Olea Sphere®, including new advanced post-processing modules, is a confirmation of our capacity of innovation. It is with great pride that we introduce these new developments on a highly demanding market. We believe such new options will add significant value in the day-to-day clinical practice for the highest benefit to patients worldwide." says Fayçal Djeridane, president and CEO of Olea Medical.

Professor Denis Le Bihan, Kyoto University: "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."

About Olea Medical: Olea Medical®, a Toshiba Medical Systems Group Company, is a provider of advanced MR and CT perfusion imaging post-processing, designs and markets a suite of innovative medical imaging applications, Olea Sphere®, significantly improving diagnostic process and follow-up assessment. The company has established a strong credibility through the domestication of cutting-edge technology and partnerships with leading institutions worldwide. With proprietary Bayesian algorithms and optimization methods applied to medical imaging, today Olea Medical® is the recognized leader in standardized, vendor-neutral, advanced MR quantitative and qualitative image post-processing. Covering both morphologic and functional imaging, Olea Medical® post-processing solutions bring complex Mathematics into clinical practice for easy access to accurate and robust biomarkers for enhanced diagnostic confidence and response-to-treatment assessment.

More information at www.olea-medical.com

About Toshiba Medical Systems Corporation
Toshiba Medical Systems Corporation is a leading worldwide provider of medical diagnostic imaging systems and comprehensive medical solutions, such as CT, X-ray and vascular, ultrasound, nuclear medicine and MRI systems, as well as information systems for medical institutions. Toshiba Medical Systems Corporation has been providing medical products for over 80 years. Visit Toshiba Medical Systems Corporation's website at www.toshibamedicalsystems.com.

Olea Medical and Olea Sphere are trademarks of Olea Medical SA.
Windows is a registered trademark of Microsoft Corporation in the United States and other countries.
Linux is a registered trademark of Linus Torvalds in the United States and other countries.

Contact information

Press Contact:
Anca Mitulescu: +33 (0) 4 42 71 24 20
VP Clinical Affairs & Marketing
Olea Medical
anca.mitulescu@olea-medical.com

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