Mauna Kea Technologies Receives FDA 510(k) Clearance of Cellvizio® with a Fluorescent Dye, Fluorescein, as Drug Device Combination
(WorldNews Europe)

The Cellvizio® 100 series system with all its different Confocal MiniprobesTM is now cleared for use with the fluorescein dye to image blood flow in the microvasculature and capillaries Mauna Kea Technologies today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Cellvizio® 100 series and all associated Confocal MiniprobesTM for the additional indication of visualization of blood flow when used in conjunction with a...