France-based Mauna Kea Technologies has secured the US Food and Drug Administration (FDA) 510(k) approval of Cellvizio 100 series and all associated Confocal Miniprobes for visualisation of blood flow, when used with fluorescein, as a drug device combination.

Cellvizio is a multidisciplinary probe and needle-based confocal laser endomicroscopy platform and the current regulatory approval marks the company’s 17th US FDA 510(k) approval of the platform.

The FDA has approved the endomicroscopy system, used in combination with fluorescein, a fluorescent dye, with an additional indication for imaging blood flow in vascular areas, including microvasculature and capillaries.

Cellvizio approved for a range of applications in more than 40 countries

Cellvizio has been developed as an in vivo, real-time endomicroscopic visualisation technology platform for imaging of internal microstructure of tissues, for the identification of cells and vessels, and their organisation and architecture.

In addition, endomicroscopy system can be used in gastroenterology, pulmonology, and urology during endoscopic procedures, laparoscopic and robot-assisted surgeries, and image-guided percutaneous procedures, and has been approved in a wide range of applications in more than 40 countries.

Mauna Kea said that the FDA approval of the endomicroscopy system is supported by the 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 United States by allowing the fluorescein dye to be directly supplied with Cellvizio. This clearance is another step for Mauna Kea Technologies in an accelerated development of drug-device combination indications, enabling the clinical use of Cellvizio with highly specific molecular imaging markers.”