Mauna Kea Technologies announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Cellvizio® 100 series and all associated Confocal Miniprobes™ for the additional indication of visualization of blood flow when used in conjunction with a fluorescent dye, fluorescein, as a drug device combination. This marks the 17thU.S. FDA 510(k) clearance of the Cellvizio® p/nCLE platform. The Mauna Kea Technologies Cellvizio in vivo, real-time endomicroscopic visualization technology platform is intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture. The endomicroscopy system is used in the fields of gastroenterology, pulmonology, and urology during endoscopic procedures, laparoscopic and robot-assisted surgeries, and image-guided percutaneous procedures. FDA clearance of the endomicroscopy system in combination with a fluorescent dye, fluorescein, and the addition of the indication for imaging blood flow in vascular areas, including microvasculature and capillaries, represents a pivotal milestone for the Company. Real-world data, published in multiple peer-reviewed medical journals by leading investigators, paved the way for this new FDA clearance. Cellvizio has, for sometime, been an important adjunct to traditional biopsy and histopathological examination.