FDA 510(k) Clearance For Olea Sphere Medical Imaging Software

In short

Imaging specialist Olea Medical, has obtained FDA 510(k) clearance to market its Olea Sphere medical imaging enterprise software package in the US.


Olea Medical, with facilities in Marseilles and Boston, designs and markets innovative perfusion imaging applications that it claims significantly improve diagnostic processes. The company is aiming to become the leader in providing safe and accurate medical imaging software allowing physicians to make faster and improved diagnoses.

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 chose to partner with Emergo Group for its 510(k) submission.

Company comments

“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. 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.”

Source: Olea Medical, PR Web