Mauna Kea Technologies Gets FDA Clearance for its Cellvizio Probe

Mauna Kea Technologies’ Cellvizio 100 Series needle-based laser endomicroscopy platform has received an additional FDA 510(k) clearance.

The new clearance covers the use of the Cellvizio probe with a molecular-imaging agent for real-time visualization during endoscopic, laparoscopic and needle-based procedures.

Cellvizio is now cleared to perform fluorescence imaging of tissues that have taken up indocyanine green or On Target Laboratories’ fluorescent drug Cytalux (pafolacianine).

The 510(k) clearance includes all Cellvizio confocal miniprobes in all cleared clinical indications, Mauna Kea said.