Olea Medical Wins FDA 510(k) Clearance for Olea Sphere Medical Imaging Software

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Medical device manufacturer expands US market presence with support from Emergo Group.

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Olea Medical, a Marseilles, France and Boston, Mass.-based medical technology developer, has obtained FDA 510(k) clearance to market its Olea Sphere medical imaging enterprise software package in the US.

Designed to run on Windows, Macintosh and Linux operating systems, Olea Sphere provides display, analysis and post-processing functionality for viewing MRI, CT scan and other medical images, such as perfusion weighted or diffusion weighted images. Using Olea Sphere, medical professionals can not only view but also manipulate and process MRI and CT images. Olea Medical obtained FDA 510(k) clearance with assistance from Austin, Texas-based medical device consultancy Emergo Group.

“It seemed important to us to benefit from the expertise of a specialist in the medical device regulatory field,” Fayçal Djeridane, President and CEO of Olea Medical, explains. “Such an approach usually helps us gain a lot of time with 510(k) file submissions.”

Olea Medical chose to partner with Emergo Group due to the consultancy’s reputation and high level of expertise. “Emergo Group consultants have worked with the FDA on many 510(k) files, so they definitely have the appropriate skills to lead successful submissions,” says Djeridane. “They know exactly the FDA’s expectations and point of view. The result of our investment in teaming with Emergo Group was that we got our 510(k) clearance without delays.”

“The FDA’s 510(k) premarket notification process can be complex and labor-intensive for US-based as well as foreign manufacturers alike,” says Fabio De Pasquale, senior consultant at Emergo Group. “By choosing Emergo Group to provide US FDA registration assistance, Olea Medical was able to bring an innovative medical technology to market in the US quickly and straightforwardly, with no complications.”

About Olea Medical
Olea Medical designs and markets innovative perfusion imaging applications that significantly improve diagnostic processes. Olea Medical aims to become the leader in providing safe and accurate medical imaging software allowing physicians to make faster and improved diagnoses. More information at http://www.olea-medical.com.

About Emergo Group
Emergo Group is a global medical device consulting firm providing a wide range of services for medical device compliance including FDA approval and registration,QMS compliance, clinical trial management, in-country representation, reimbursement and distributor search consulting. Emergo Group can be found online at http://www.emergogroup.com

Additional information:
Caroline Lene
Quality & Regulatory Affairs Manager
Olea Medical

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