Olea Medical® Receives FDA 510(k) Clearance for Olea Sphere v2.3 Medical Imaging Software

Olea Sphere 2.3 receives FDA 510(k) Clearance Olea Medical®, a medical technology developer with headquarters at La Ciotat, France, and offices in Cambridge, MA, US, has obtained FDA 510(k) clearance to market the 2.3 version of Olea Sphere medical imaging enterprise software package in the US.

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La Ciotat, France (PRWEB) January 10, 2014

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 and analysis, processing of perfusion weighted image post-processing, permeability computation, as well as diffusion weighted image/tensor image post-processing, fiber tracking post-processing, and longitudinal analysis of multiple time points. It is compliant with the DICOM standard and Windows, Macintosh or Linux operating systems. It runs on any standard off-the-shelf workstation or it can be used through a thin deployment with a server. Olea Sphere 2.3 was CE marked in October 2013 and received FDA 510(k) clearance end of December 2013.

“The FDA clearance of this new version of our image processing software package is an important milestone for Olea Medical®. Indeed, among other significant new features, this package includes now our Bayesian post-processing proprietary algorithm, the result of over 3 years of investment in research and innovation,” said Fayçal Djeridane, President and CEO of Olea Medical®. “Such an accomplishment reinforces our confidence in our science-based strategy and positions us as the worldwide leader in CT and MR perfusion imaging post-processing. But, most importantly, such innovative applications will lead the way towards standardized image post-processing in routine clinics, greatly facilitating doctors’ reading work and image interpretation for the utmost benefit to patients,” he added.

Along with the Bayesian post-processing method, Olea Sphere 2.3 also features a T1 mapping plug-in and a unique subtraction option dedicated to lesion progression follow-up in patients with long-term diseases.

About Olea Medical®:
Olea Medical® designs and markets innovative medical imaging applications that significantly improve diagnostic processes and treatment evaluation. Olea Medical® aims to become the leading provider of safe and accurate medical imaging software. More information at http://www.olea-medical.com.

CONTACT:     
Anca Mitulescu
Olea Medical®
+33 (0) 4 42 71 71 64
anca.mitulescu(at)olea-medical(dot)com


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