The US Food and Drug Administration (FDA) has granted 510(k) approval to Olea Medical's Olea Sphere medical imaging enterprise software.
Olea Sphere provides display, analysis and post-processing functionality for viewing perfusion weighted or diffusion weighted MRI, CT scan images as well as facilitates medical professionals to manipulate and process MRI and CT images.
Olea Medical said it has chosen US-based medical device consultancy, Emergo Group, to gain FDA registration.
Olea Medical president and CEO Fayçal Djeridane said it seemed important to the company to benefit from the expertise of a specialist in the medical device regulatory field.
"The result of our investment in teaming with Emergo Group was that we got our 510(k) clearance without delays," Djeridane added.
Emergo Group senior consultant Fabio De Pasquale said the FDA’s 510(k) premarket notification process can be complex and labor-intensive for US-based as well as foreign manufacturers.
"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," Pasquale added.