Mauna Kea Technologies, France has secured the US Food and Drug Administration (FDA) 510(k) approval for Cellvizio 100 series and all associated Confocal Miniprobes for visualisation of blood flow when used with drug combination fluorescein.
Cellvizio is a multidisciplinary probe and needle-based confocal laser endomicroscopy platform. The platform, developed as an in vivo, real-time endomicroscopic visualisation technology, identifies cells and vessels, and their organisation and architecture.
It is the company’s 17th US FDA 510(k) approval of the platform, supported in an extensive range of applications in more than 40 countries.
The company claims the FDA’s approval for the system, used in combination with fluorescein, a fluorescent dye and indication for imaging blood flow in vascular areas, is a significant milestone.
Endomicroscopy system can be employed in gastroenterology, pulmonology and urology while carrying out endoscopic procedures, laparoscopic and robot-assisted surgeries and image-guided percutaneous procedures.
FDA approval of the endomicroscopy system is supported by real-world data published in various medical journals.
Mauna Kea chief executive officer Robert L Gershon said: “This new FDA clearance of our Cellvizio platform in combination with a fluorescent dye is a major regulatory milestone for Mauna Kea Technologies. It validates the wealth of data that have been published over the past decade that demonstrates its important clinical contribution.
“This FDA clearance will greatly facilitate our commercial development in the United States by allowing the fluorescein dye to be directly supplied with Cellvizio. This clearance is another step for Mauna Kea Technologies in accelerated development of drug-device combination indications, enabling the clinical use of Cellvizio with highly specific molecular imaging markers.”
