Mauna Kea Technologies: new authorization in the United States

(AOF) – Mauna Kea Technologies announces the first 510(k) clearance from the FDA for the use of the Cellvizio in a new category of endoscopic, laparoscopic and needle procedures guided by molecular imaging. This authorization is for the use of Cellvizio in the fluorescence imaging of tissues targeted by a molecular marker, Pafolacianin, marketed as Cytalux and manufactured by On Target Laboratories, in accordance with its approved use and method of administration. .

Additionally, the authorization includes a new clinical indication for the use of Cellvizio for fluorescence imaging and visualization of ICG (indocyanine green), intravenously or interstitially, in accordance with the use and direction. the approved method of administration of the ICG. The 510(k) includes all Cellvizio Confocal Miniprobes in all authorized clinical indications.


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