Olea Medical krijgt fiat van FDA voor Olea Sphere 3.0
LA CIOTAT, Frankrijk–(BUSINESS WIRE)– 21 maart 2016: Olea Medical, aanbieder van geavanceerde nabewerking van MR- en CT-beelden van doorbloeding, heeft vandaag bekendgemaakt dat de FDA zijn zakelijke beeldsoftwarepakket Olea Sphere 3.0 heeft goedgekeurd in de Verenigde Staten.
Olea Sphere is een pakket met beeldverwerkingssoftware voor beeldarchieven, nabewerkingen en communicatie. Het helpt bij de standaardisering van kijk- en analysefuncties van MRI- of CT-datasets voor functionele en dynamische weergaven. Het ziet, analyseert en bewerkt op innovatieve wijze de meest complexe MR-sequenties, maar zorgt ook voor analyses van meerdere tijdpunten over een lange periode. Olea Sphere voldoet aan de DICOM-standaard en werkt met de besturingssystemen Windows en Linux.
Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.
Contacts
Press Contact:
Anca Mitulescu: +33 (0) 4 42 71 24 20
VP Clinical Affairs & Marketing
Olea Medical
anca.mitulescu@olea-medical.
Olea Medical Receives FDA Clearance for Olea Sphere 3.0 |
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LA CIOTAT, France–(BUSINESS WIRE)– 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 Olea Medical and Olea Sphere are trademarks of Olea Medical SA. View source version on businesswire.com: http://www.businesswire.com/news/home/20160321005041/en/ Contacts Press Contact: |
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